Home » Lumbopelvic

Lumbopelvic

Author Names
Mehyar, F., Santos, M., Wilson, S. E., Staggs, V. S., and Sharma, N. K.
Reviewer Name
Abby Bergeron, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract
Background: Lumbar mobilization is a standard intervention for lower back pain (LBP). However, its effect on the activity of back muscles is not well known.
Objectives: To investigate the effects of lumbar mobilization on the activity/contraction of erector spinae (ES) and lumbar multifidus (LM) muscles in people with LBP.
Design: Randomized controlled study.
Methods: 21 subjects with LBP received either grade III central lumbar mobilization or placebo (light touch) intervention on lumbar segment level 4 (L4). Surface electromyography (EMG) signals of ES and ultrasound (US) images of LM were captured before and after the intervention. The contraction of LM was calculated from US images at L4 level. The normalized amplitude of EMG signals (nEMG) and activity onset of ES were calculated from the EMG signals at both L1 and L4 levels.
Results: Significant differences were found between the mobilization and placebo groups in LM contraction (p=0.03), nEMG of ES at L1 (p=0.01) and L4 (p=0.05), and activity onset of ES at L1 (p=0.02).
Conclusion: Lumbar mobilization decreased both the activity amplitude and the activity onset of ES in people with LBP. However, the significant difference in LM contraction was small and may not have clinical significance.

NIH Risk of Bias Tool
Quality Assessment of Controlled Intervention Studies
1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
-Yes
2. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
-Yes
3. Was the treatment allocation concealed (so that assignments could not be predicted)?
-Cannot Determine, Not Reported, or Not Applicable
4. Were study participants and providers blinded to treatment group assignment?
-No
5. Were the people assessing the outcomes blinded to the participants’ group assignments?
-No
6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
-Cannot Determine, Not Reported, or Not Applicable
7. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
-Yes
8. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
-Yes
9. Was there high adherence to the intervention protocols for each treatment group?
-Yes
10. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
-Yes
11. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
-Yes
12. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
-Cannot Determine, Not Reported, or Not Applicable
13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
-Yes
14. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
-Cannot Determine, Not Reported, or Not Applicable

Key Finding #1
There was a significant difference between the mobilization and placebo groups in the changes of lumbar multifidus contraction, normalized amplitudes of EMG of erector spinae, and activity onset of erector spinae.
Key Finding #2
Mobilization led to reduced EMG activity of the erector spinae compared to the placebo group in participants with severe pain. Erector spinae EMG changes were not statistically significant in participants with moderate pain.
Key Finding #3
Mobilization led to increased lumbar multifidus contraction compared to the placebo group in only the participants with moderate pain.
Key Finding #4
The mobilization intervention significantly decreased the time of erector spinae onset compared to the placebo intervention.

Please provide your summary of the paper
As low back pain has been found to be associated with increased activity of erector spinae (superficial back muscle) and decreased activity of lumbar multifidus (deep back muscle), this 2020 randomized controlled trial aimed to examine how grade III lumbar mobilization impacts the activity of these muscles. Twenty-one participants with low back pain were randomly assigned to either the mobilization group (10 subjects) or the placebo group (11 subjects). The mobilization group received grade III central lumbar mobilizations at L4, while the placebo group received light touch to the same area. The intervention was delivered in four bouts of sixty seconds at two separate sessions (2 to 4 days apart). At each session, a normalization back-lift task and arm-lift task were performed by the subject and ultrasound, EMG, and pressure pain threshold measures were obtained to assess muscle activation and quantify pain. There was a statistically significant difference between the mobilization and placebo groups in the changes of lumbar multifidus contraction, EMG activity of erector spinae, and activity onset of erector spinae. However, the increases in lumbar multifidus contraction were only significant in subjects with moderate pain, and the change (3%) was lower than the reported minimum detectible change for this measure (11-13%). Further, the reduction in EMG activity of erector spinae was only significant in participants with severe pain. The participants in the mobilization group also demonstrated a significantly reduced time of erector spinae activity onset compared to the placebo group. The authors of this study concluded that this could indicate improved synergistic activity of the erector spinae and posterior deltoid during the prone arm-lift task.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.

Abnormal activity of superficial and deep muscles in patients with low back pain may lead to increased pain and function limitations. Previous studies have examined how manual therapy interventions, such as thrust manipulation and lumbar mobilizations, can reduce pain and promote hypoalgesia. This study indicates that implementing grade III lumbar manipulations into the plan of care for such patients could normalize erector spinae and lumbar multifidus activation to better manage their chronic pain. Though the change in lumbar multifidus contraction may not be clinically significant, grade III mobilizations may still benefit patients by providing analgesic effects and decreasing erector spinae activity.

Author Names

Peterson, C; Haas, M; Gregory, W

Reviewer Name

Sophie Zubella, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy.  Methods: Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events.  Results: Fifty-seven participants were randomized into the exercise (n = 22), spinal manipulation (n = 15), and Neuro Emotional Technique (n = 20) treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically meaningful or statistically significant differences between groups in any analysis.  Conclusions: This pilot study demonstrated feasibility for recruitment, compliance, safety, and affordability for conducting a larger study in the future. Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain, but the study was not powered to detect the between-group differences as statistically significant.  Trial registration: ClinicalTrials.gov (Identifier: NCT00937365).

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • No
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • No
  1. Was there high adherence to the intervention protocols for each treatment group?
  • No
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

Clinically meaningful improvement in function and pain were found in both the exercise and spinal manipulative therapy groups.

Key Finding #2

It is feasible to conduct research on how manual therapy affects pregnancy related low back pain in a safe manner with adherence to care.

Key Finding #3

The spinal manipulation group experienced the largest improvement in function and pain.

 

Please provide your summary of the paper

This paper discusses the feasibility of conducting research on conservative methods of treating pregnancy-related low back pain (PRLBP) and analyzes the effects of exercise, spinal manipulative therapy, and nero-emotional technique PRLBP. The authors conducted a randomized control study where each participant was randomly assigned one of the three conservative treatments to treat LBP during their pregnancy. The study showed that all groups showed clinically meaningful improvement in function, and the spinal manipulative therapy and exercise groups both showed clinically meaningful improvements in function and pain, with the spinal manipulative therapy group having the greatest improvement. The study also found that it is feasible to conduct research of this nature on the pregnant population, and a larger scale study should be implemented to have the power to detect detailed between-group differences. Limitations of the study include that the researcher was not blinded to the participant groups during the analysis phase, and women were allowed to enter the study at any point in their pregnancies, which made it difficult to gather sufficient data from latecomers.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This paper discusses how pregnancy-related low back pain is a common condition that, if left untreated, can persist years after giving birth. While it’s important to investigate contraindications to treatment in the pregnant population, this study shows that it is safe and effective to perform spinal manipulation for pregnancy related lower back pain. It’s also feasible to conduct research on conservative treatments to pregnancy related low back pain, and important to do so given that pharmacological treatments for this condition are under-researched and long term-consequences for these treatments are not yet known.

Author Names

Rodríguez-Pastor, J., Caro-Puértolasa, B., Caña-Pino, A., Sánchez-Preciado, A., Garrido-Ardila, E., Apolo-Arenas, M.

Reviewer Name

Daniel Vay, SPT, ATC, LAT

Reviewer Affiliation(s)

Duke University Doctorate of Physical Therapy Division

Paper Abstract

BACKGROUND: One of the main problems faced by physiotherapists in primary care is low back pain with or without radiation to lower limbs. There are many different treatment approaches for the management of low back pain. Despite the large amount of published studies, the evidence remains contradictory. OBJECTIVE: To evaluate the influence of the osteopathic manipulation of the sacroiliac joint on low back pain with or without radiation to lower limbs. METHOD: Single-blind randomized clinical controlled trial. Participants with low back pain with or without lower limb radiation were randomized to osteopathic manipulation of the sacroiliac joint group (intervention, 6 sessions) or to an electrotherapy group (control, 15 sessions) for 3 weeks. Measures were taken at baseline (week 0) and post-intervention (week 4). The primary outcome measures were pain (Visual Analogue Scale), functional disability (Oswestry disability index and Roland Morris questionnaire). The secondary outcome measure was pain threshold at muscular tender points in the quadratus lumborum, pyramidal, mayor gluteus, and hamstrings. RESULTS: In all, 37 participants completed the study. The results of the intragroup comparisons showed statistically significant improvements in both groups in the visual analogue scale (Osteopathic manipulation group, P = 0.000; Electrotherapy group, P = 0.005) and Oswestry disability index (Osteopathic manipulation group, P = 0.000; Electrotherapy group- P = 0.026) but not in the Roland Morris questionnaire (P = 0.121), which only improved in the intervention group (P = 0.01). The osteopathic manipulation was much more effective than electrotherapy improving to pain and functional disability. CONCLUSION: Osteopathic manipulation of the sacroiliac joint improves pain and disability in patients with sacroiliac dysfunction after three weeks of treatment.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • No
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • No
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • No
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

Key Finding #1

Both osteopathic manipulation and electrotherapy treatments were effective in reducing pain and disability in patients through the Oswestry Disability Index.

Key Finding #2

Intergroup analysis revealed that osteopathic manipulation was more effective for pain and functional disability than electrotherapy treatment.

Key Finding #3

Osteopathic manipulation required less treatment sessions to achieve improvements in pain (6 sessions maximum) as compared to the electrotherapy group (15 sessions).

Key Finding #4

Electrotherapy only proved to be effective on the Oswestry disability index, when patients are more affected with greater impairment and functional disability.

 

Please provide your summary of the paper

This study looked at the effectiveness of osteopathic manipulations of the SIJ vs electrotherapy on the ratings of pain and functional disability. The primary outcome measures were the Visual Analogue scale (VAS), Oswestry Disability Index, and the Roland Morris Questionnaire. A total of 37 patients out of 150 were included after the exclusion criteria was put in place. The Intervention group (osteopathic manipulation) completed a total of 6 sessions over the span of 3 weeks, 2 sessions per week. The control group (electrotherapy) completed a total of 15 sessions over 3 weeks, 5 sessions per week. Both treatments were performed by a qualified physiotherapist member of the Spanish Chartered Society of Physiotherapists, trained in joint osteopathic manipulation and electrotherapy. The results found that both treatments were effective in reducing pain and disability through the Oswestry Disability Index. Although, through intergroup analysis, the osteopathic manipulation intervention group revealed to be the more effective method.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The direct clinical impacts from this paper include the potential benefits for implementing osteopathic manipulation and electrotherapy for patients with low back pain with or without radiation to the lower limbs. Given the results of the study, the effectiveness of osteopathic manipulation in reducing pain and functional disability over a short duration of treatment sessions shows important consideration for clinicians when comparing the multiple methods of treatment. Further research is needed to investigate long term effects of osteopathic manipulation and further studies with increases in sample size and more specific inclusion criteria can help improve clinical decision making regarding these methods.

Author Names

Farrokhi, S. Bechard, L. Gorczynski, S. Patterson, C. Kakyomya, J. Hendershot, B. Condon, R. Perkins, M. Rhon, D. Delitto, A. Schneider, M. Dearth, C.

Reviewer Name

Emma Velez, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective

The aim of this study was to explore associations between the utilization of active, passive, and manual therapy interventions for low back pain with one-year escalation-of-care events including opioid prescriptions, spinal injections, specialty care visits, and hospitalizations.

Methods

This was a retrospective cohort study of 4827 patients identified via the Military Health System Data Repository who received physical therapist care for low back pain in 4 outpatient clinics between January 1, 2015 and January 1, 2018. One-year escalation-of-care events were evaluated based on type of physical therapist interventions (ie, active, passive, or manual therapy) received using adjusted odds ratios.

Results

Most patients (89.9%) received active interventions. Patients with 10% higher proportion of visits that included at least 1 passive intervention had a 3% to 6% higher likelihood of one-year escalation-of-care events. Similarly, with 10% higher proportion of passive to active interventions used during the course of care, there was a 5% to 11% higher likelihood of one-year escalation-of-care events. When compared to patients who received active interventions only, the likelihood of incurring one-year escalation-of-care events were 50 to 220% higher for those who received mechanical traction and 2 or more different passive interventions, but lower by 50% for patients who received manual therapy.

Conclusion

Greater use of passive interventions for low back pain was associated with elevated odds of one-year escalation-of-care events. In addition, the use of specific passive interventions such as mechanical traction in conjunction with active interventions resulted in suboptimal escalation-of-care events, while the use of manual therapy was associated with more favorable downstream health care outcomes.

Impact

Physical therapists should be judicious in use of passive interventions for management of low back pain as they are associated with greater likelihood of receiving opioid prescriptions, spinal injections, and specialty care visits.

NIH Risk of Bias Tool

Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies

  1. Was the research question or objective in this paper clearly stated?
  • Yes
  1. Was the study population clearly specified and defined?
  • Yes
  1. Was the participation rate of eligible persons at least 50%?
  • Yes
  1. Were all the subjects selected or recruited from the same or similar populations (including the same time period)? Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants?
  • Yes
  1. Was a sample size justification, power description, or variance and effect estimates provided?
  • No
  1. For the analyses in this paper, were the exposure(s) of interest measured prior to the outcome(s) being measured?
  • Yes
  1. Was the timeframe sufficient so that one could reasonably expect to see an association between exposure and outcome if it existed?
  • Yes
  1. For exposures that can vary in amount or level, did the study examine different levels of the exposure as related to the outcome (e.g., categories of exposure, or exposure measured as continuous variable)?
  • Yes
  1. Were the exposure measures (independent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?
  • Yes
  1. Was the exposure(s) assessed more than once over time?
  • No
  1. Were the outcome measures (dependent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?
  • Yes
  1. Were the outcome assessors blinded to the exposure status of participants?
  • Yes
  1. Was loss to follow-up after baseline 20% or less?
  • Yes
  1. Were key potential confounding variables measured and adjusted statistically for their impact on the relationship between exposure(s) and outcome(s)?
  • Yes

 

Key Finding #1

36.8% of patients who received only active therapeutic interventions during their time in PT received opioid prescriptions within the following year. The rate of opioid prescription rises as more passive therapies were used in the PT plan of care.

Key Finding #2

Using manual therapy in conjunction with active interventions decreases the likelihood of spinal injections and the incidence of seeking further specialty care for follow-up.

Key Finding #3

The longer a plan of care went on, the more likely it was to see additional passive therapies included in treatment. The rates of opioid prescription of the exclusively passive therapies group and the active therapies plus two or more passive interventions were comparable at 47.8% and 46.4% respectively.

Please provide your summary of the paper

Passive interventions to treat LBP increase the likelihood of long-term adverse events, especially opioid use. This research best supports the use of active therapeutic interventions as a first-line treatment of LBP, with the addition of manual therapy techniques to help further improve health outcomes. Limitations of this study include a narrow population, as all subjects were obtained from the Military Health System. This resulted in 77.2% of participants being male with an average age of 34 years old. The types of therapies studied were determined exclusively by CPT codes. No treatment details were determined or analyzed from the therapists’ session notes.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This study further supports the 2021 APTA CPG recommendations for patients with acute, subacute, and chronic LBP that state that these patients should be treated with a combination of exercise and manual therapies. The dosage of these interventions requires clinical reasoning and will vary amongst patients.

Author Names

Liddle, Sarah D; Pennick, Victoria

Reviewer Name

Darice Upchurch, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

More than two‐thirds of pregnant women experience low‐back pain and almost one‐fifth experience pelvic pain. The two conditions may occur separately or together (low‐back and pelvic pain) and typically increase with advancing pregnancy, interfering with work, daily activities and sleep.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses

  1. Is the review based on a focused question that is adequately formulated and described?
  • Yes
  1. Were eligibility criteria for included and excluded studies predefined and specified?
  • Yes
  1. Did the literature search strategy use a comprehensive, systematic approach?
  • Yes
  1. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?
  • Cannot Determine, Not Reported, Not Applicable
  1. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?
  • Yes
  1. Were the included studies listed along with important characteristics and results of each study?
  • Yes
  1. Was publication bias assessed?
  • Yes
  1. Was heterogeneity assessed? (This question applies only to meta-analyses.)
  • Yes

 

Key Finding #1

Exercise can significantly reduce low-back pain and functional disability more than just prenatal care alone.

Key Finding #2

No change in low back or pregnancy related pelvic pain who received spinal manipulations.

Key Finding #3

Multi-modal interventions such as manual therapy, exercise, and education can be a benefit to reduce low-back pain and functional disability short term.

Key Finding #4

 

Please provide your summary of the paper

This study did a randomized controlled trial to find methods of treatment used to prevent or treat pregnancy related pain. The results of this study was based on pregnant women ages 16-45 who are experiencing low-back, pelvic pain, or a combination of both. There is an understanding that as the pregnancy progresses, so does the pain and it tends to affect sleep, work, and daily activities. Each treatment method was added in addition to the usual prenatal care. Exercise was shown to be the most successful with reducing low back pain and functional disability for short-term treatment. There was no difference between group and independent exercise. Other interventions such as yoga, spinal manipulations, and TENS were assessed and no improvements in pain were noted.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

There are many interventions that are given to patients who have an increase in low back pain and pelvic pain while pregnant. While some interventions may work it is only for a short amount of time and this will vary between patients. This study gave insight that although we may not be able to completely stop the pain, we are able to implement and instruct patients on how to minimize it in order to reduce the limitations. Improvements in pain and functional disability can have an effect on sleep, daily activities, and work.  This study could have been better organized if it was stated whether this was the first pregnancy or not, tracking how consistent the patients were with their intervention, and grouping the stage of the pregnancy (how far along in pregnancy). Pain increases the further along in pregnancy so it would be unique to note the difference between the pain during the different stages.

Author Names

Satpute, K., Hall, T., Bisen, R., Lokhande, P.

Reviewer Name

Bree Tucker, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objectives: To evaluate the effect of spinal mobilization with leg movement (SMWLM) on low back and leg pain intensity, disability, pain centralization, and patient satisfaction in participants with lumbar radiculopathy.
Design: A double-blind randomized controlled trial.
Setting: General hospital.
Participants: Adults (NZ60; mean age 44y) with subacute lumbar radiculopathy.
Interventions: Participants were randomly allocated to receive SMWLM, exercise and electrotherapy (nZ30), or exercise and electrotherapy alone (nZ30). All participants received 6 sessions over 2 weeks.
Main Outcome Measures: The primary outcomes were leg pain intensity and Oswestry Disability Index score. Secondary variables were low back pain intensity, global rating of change (GROC), straight leg raise (SLR), and lumbar range of motion (ROM). Variables were evaluated blind at baseline, post-intervention, and at 3 and 6 months of follow-up.
Results: Significant and clinically meaningful improvement occurred in all outcome variables. At 2 weeks the SMWLM group had significantly greater improvement than the control group in leg pain (MD 2.0; 95% confidence interval [95% CI], 1.4-2.6) and disability (MD 3.9; 95% CI, 5.5- 2.2). Similarly, at 6 months, the SMWLM group had significantly greater improvement than the control group in leg pain (MD 2.6; 95% CI, 1.9- 3.2) and disability (MD 4.7; 95% CI, 6.3-3.1). The SMWLM group also reported greater improvement in the GROC and in SLR ROM.

Conclusion: In patients with lumbar radiculopathy, the addition of SMWLM provided significantly improved benefits in leg and back pain, disability, SLR ROM, and patient satisfaction in the short and long term.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

The inclusion of spinal mobilization with leg movement (SMWLM) in conjunction with exercise and TENS proved to significantly improve leg and low back pain, as well as disability and SLR ROM. Leg pain intensity and ODI scores reduced significantly more in those who received SMWLM post-intervention, at 3 months, and at 6 months than that of the control group.

Key Finding #2

Participants reported centralization of leg pain immediately after 2 weeks of intervention, more significantly in the SMWLM group in comparison to the control group. By the end of the trial, 100% of participants in the SMWLM group reported centralization.

Key Finding #3

Both groups showed improvements in all outcome measures performed; however, the SMWLM group demonstrated more significant improvements immediately after intervention that maintained throughout the duration of the trial.

Key Finding #4

Results of this study are consistent with those of others related to manual therapy treatment for lumbar radiculopathy; however, the addition of SMWLM resulted in more rapid and greater improvements in leg pain severity.

 

Please provide your summary of the paper

This study aimed to examine the benefits to spinal mobilization with leg movement (SMWLM) when added to traditional interventions in patients with lumbar radiculopathy. The trial followed a double-blind randomized control design which included patients presenting with unilateral radiating leg pain below the knee with associated low back pain. Sixty participants with severe disability ratings received 6 treatment sessions over 2 weeks and reported follow-ups at 3-months and 6-months. Participants either received SMWLM with exercise and TENS, or only exercise and TENS. Primary outcome measures of the visual analog scale (VAS) and Oswestry Disability Index (ODI), along with other supplemental outcome measures, were used to measure change in leg pain and disability.

Results of the study showed both groups demonstrated improvements on all outcome measures; however, the SMWLM group showed more significant improvements immediately after intervention that persisted 6 months later. Reports of leg pain reduced significantly more, as well as a reduction in ODI scores, in the SMWLM group at all three time-points of the trial in comparison to the control group. It was therefore concluded that the addition of SMWLM to exercise and TENS provided improvements in leg and low back pain, disability, and ROM in those with lumbar radiculopathy.

This was the first randomized control trial to evaluate the efficacy of SMWLM in the management of lumbar radiculopathy. Limitations to the study include not monitoring for compliance with the home exercise program and longer treatment sessions for the SMWLM group compared to the control. This study also only included participants who positively responded to a trial of SMWLM during examination.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

Low back pain is a common musculoskeletal problem and can often be associated with radiculopathy. Manual therapy has been studied as an effective treatment for radicular symptoms. From this article, we learn that the inclusion of exercise and TENS alone for this patient population can help to further manage symptoms. However, the additional adaptation of SMWLM within therapy sessions may produce more rapid and long-lasting benefits for these patients suffering with severe leg pain secondary to suspected lumbar radiculopathy. Any manual therapy practitioner, or general physical therapist, can use this data to justify the implementation of similar treatment programs for this patient population. Pain-free mobilizations of nerves are preferable making the SMWLM a useful tool for management of radiculopathy to implement in regular PT practice. Future studies are recommended to identify the mechanism of action of SMWLM, as well as to investigate the efficacy of SMWLM compared to surgical treatment options.

Author Names

Saracoglu, I., Isintas, A.M., Afsar, E., Gokpinar, H.H.

Reviewer Name

Abigail Tolstyka, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Objectives: The aim of this study was to investigate the short- and mid-term effects of pain neuroscience education (PNE) combined with manual therapy (MT) and a home exercise program (HEP) on pain intensity, back performance, disability, and kinesiophobia in patients with chronic low back pain (CLBP). Methods: This study was designed as a prospective, randomized, controlled, single-blind study in which 69 participants were randomly assigned to three groups. Participants in Group 1 received PNE, MT, and the HEP, while Group 2 received MT and the HEP. Participants in the control group did the HEP only. All interventions lasted 4 weeks. The participants’ pain intensity, disability, low back performance, and kinesiophobia were assessed. All assessments were executed before intervention, at 4 weeks, and at 12 weeks post-intervention by the same blinded physiotherapist. A mixed model for repeated measures was used for each outcome measure. Results: Analysis of pain level (p < .05), back performance (p < .05), disability (p < .05) and kinesiophobia (p < .05) revealed significant time, group, and time-by-group interaction effects. The participants in Group 1 exhibited greater improvement in terms of pain intensity and kinesiophobia compared to the participants in Group 2 and the control group. Level of disability was significantly decreased in both Group 1 and Group 2 compared to the control group. Conclusion: This study suggests that a multimodal treatment program combining PNE, MT, and HEP is an effective method for improving back performance and reducing pain, disability, and kinesiophobia in the short (4 weeks) and midterm (12 weeks).

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

Key Finding #1

A multimodal program including pain neuroscience education (PNE), manual therapy, and home exercise programs to treat chronic LBP improved pain levels, disability, low back performance, and kinesiophobia within 4 weeks of treatment.

Key Finding #2

Combining manual therapy and exercise with cognitive and behavioral approaches may provide greater benefit in patients with chronic low back pain or other chronic pain. The implementation of manual therapy and exercise alone may be inadequate in comparison.

 

Please provide your summary of the paper

This study aimed to evaluate several factors contributing to low back pain including low back performance, pain intensity, kinesiophobia, and disability to determine the short term effects of a combined treatment approach. Interventions for the chronic low back pain (CLBP) participants in this study consisted of manual therapy, home exercise programs, and pain neuroscience education. There was a total of 69 participants, ages 18-65 years old, split into three different groups. Each participant had experienced CLBP for at least 6 months and reported their pain intensity as 5/10 or higher. The first group received PNE, manual therapy, and home exercise programs. The second group received strictly manual therapy and home exercise programs. Finally, the third group (i.e. control group) only participated in the home exercise programs. The study lasted approximately 4 weeks. Each week, a scheduled PNE session was held for group one participants. These sessions lasted about 40-45 minutes long and were conducted by the same physiotherapist weekly. For groups one and two, manual therapy was given twice per week for 30 minutes each. The joint mobilization techniques for LBP were provided, including low velocity, mid-range, posterior-to-anterior force to the lower lumbar spine in a prone position. As stated previously, all three groups were assigned a home exercise program. This consisted of lumbar and pelvis stretching, as well as strength training interventions. All participants were asked to perform each exercise for ten repetitions, three times per day for four weeks. All three groups were reevaluated at the end of the four weeks of interventions, then again after 12 weeks. The study found that the multimodal program including PNE, manual therapy, and home exercise programs assigned to group one was associated with clinically significant improvements in pain level, disability, low back performance, and kinesiophobia at the 12-week follow-up. Furthermore, group two also showed significant improvements in pain intensity when participating in manual therapy and home exercise programs. The control group, only participating in home exercise programs, showed no clinical improvements at the 12-week follow-up.   Limitations in this study included a variation of education levels among the participants and inability to track consistency during home exercise programs. The differing levels of education may have potentially impacted patient’s ability to learn PNE or understand the home exercise program. Along with this, adherence of the home exercise program may have lacked consistency among participants, making it difficult to determine whether the 12-week follow-up was truly accurate. Strengths of this study included similarities among participants in terms of age, body weight, body mass index, or duration of CLBP, no matter the group assigned. With this, all participants in each group had similar baseline scores for pain intensity, back performance, disability, and kinesiophobia.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

In a clinical setting, it is beneficial to implement a well-rounded plan of care to patients with chronic low back pain. By providing pain neuroscience education, physical therapists would adequately incorporate cognitive and behavioral approaches to the patient’s treatment. Common factors that negatively impact patient’s plan of care include stress, anxiety, fear avoidance, and kinesiophobia. Each topic is addressed during PNE via the fear-avoidance model. In addition to education, manual therapy and home exercise programs should be implemented for greater benefits in patients with CLBP or other chronic pain. This multimodal treatment program is associated with significant improvements in pain levels, disability, low back performance, and kinesiophobia, and would be beneficial in an outpatient orthopedic setting for CLBP.

Author Names

Walston, Z., Hernandez, L., Yake, D.

Reviewer Name

Kechao Tang, SPT

Reviewer Affiliation(s)

Duke University School of Medicine

Paper Abstract

Background and purpose: Conservative therapies for complex regional pain syndrome (CRPS) have traditionally focused on exercise and desensitization techniques targeted at the involved extremity. The primary purpose of this case series is to report on the potential benefit of utilizing manual therapy to the lumbar spine in conjunction with traditional conservative care when treating patients with lower extremity CRPS.  Case description: Two patients with the diagnosis of lower extremity CRPS were treated with manual therapy to the lumbar spine in conjunction with education, exercise, desensitization, and soft tissue techniques for the extremity.  Outcomes: Patient 1 received 13 sessions over 6 weeks resulting in a 34-point improvement in oswestry disability index (ODI) and 35-point improvement in lower extremity functional scale (LEFS). Patient 2 received 21 sessions over 12 weeks resulting in a 28-point improvement in ODI and a 41-point improvement in LEFS.  Discussion: Both patients exhibited reductions in pain and clinically meaningful improvements in function. Manual therapies when applied to the lumbar spine in these patients as part of a comprehensive treatment plan resulted in improved spinal mobility, decreased pain, and reduction is distal referred symptoms. Although one cannot infer a cause and effect relationship from a case series, this report identifies meaningful clinical outcomes potentially associated with manual physical therapy to the lumbar spine for two patients with complex regional pain syndrome type 1.

NIH Risk of Bias Tool

Quality Assessment Tool for Case Series Studies

  1. Was the study question or objective clearly stated?
  • Yes
  1. Was the study population clearly and fully described, including a case definition?
  • Yes
  1. Were the cases consecutive?
  • Cannot Determine, Not Recorded, Not Applicable
  1. Were the subjects comparable?
  • No
  1. Was the intervention clearly described?
  • Yes
  1. Were the outcome measures clearly defined, valid, reliable, and implemented consistently across all study participants?
  • No
  1. Was the length of follow-up adequate?
  • Cannot Determine, Not Recorded, Not Applicable
  1. Were the statistical methods well-described?
  • Yes
  1. Were the results well-described?
  • Yes

Key Finding #1

Mobilizations were utilized on patient #1, who saw improvements in pain, ODI, and LEFS that met MCID.

Key Finding #2

Both mobilizations and manipulations were utilized on patient #2, who also saw improvements in pain, ODI, and LEFS that met MCID.

Key Finding #3

Spinal manual therapy is an effective way for a therapist to elicit change in the perception of pain and sensation and alter motor recruitment.

Key Finding #4

Both mobilization and manipulation techniques have shown benefits in addressing central and peripheral nervous system components.

 

Please provide your summary of the paper

The study showed that mobilizations and manipulations of the lumbar spine can be effective for both alleviating pain and hypersensitivity in the region, as well as improving function. They looked at two drastically different subjects: a 52-year-old male with a bilateral total hip arthroscopy and a 33-year-old female with a bilateral bunionectomy. Subject 1, the 52 year old male, went through 13 PT visits over 6 weeks, undergoing soft tissue mobilization along lumbar paraspinals and gluteus medius and non-thrust mobilizations targeting the lumbar spine. Over the course of treatment he improved his lumbar spine active range of motion and no longer had any spinal mobility limitations affecting activities of daily living. Subject 2, the 33 year old female, received 23 treatments over 12 weeks and underwent both soft tissue mobilization as well as thrust manipulations. Roughly halfway through the treatment the patient reported significant improvements in her ability to ambulate and decreased pain. Both subjects also performed therapeutic exercises as part of their treatment, progressing from open chain to closed chain with increasing resistance.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This is a study with a limited sample size, so it is difficult to draw any overarching conclusions. Still, it does show that manual therapy used in conjunction with exercises can be effective at both alleviating pain and helping restore physical function. However, given that no negative outcomes were reported, it is fair to say that manual therapy techniques are safe unless contraindicated. Whether a therapist decides to perform these techniques depends entirely on how skilled they feel they are. In case 1, the PT decided not to perform thrusts due to not having the confidence to perform them without aggravating symptoms.

Author Names

Selhorst, M., & Selhorst, B.

Reviewer Name

Michelle Su

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Objectives: Low back pain (LBP) is a common condition in adolescents. Although much has been written about the efficacy of lumbar manipulation for adults with LBP, little is known about its effectiveness in adolescents. This study had two primary aims: (1) to assess the efficacy of adding lumbar manipulation to an exercise program in adolescents with acute (>90 days) LBP and (2) to report and assess any adverse reactions associated with lumbar manipulation noted in this study. Methods: Patients were randomly assigned to receive lumbar manipulation or sham manipulation. All patients performed 4 weeks of physical therapy exercise. Pain, patient-specific functional scale (PSFS), and global rating of change (GROC) scores were measured at evaluation, 1 week, 4 weeks, and 6 months. Relative risk was calculated for adverse reactions noted. Results: We recruited 35 consecutive patients with acute LBP. One patient was excluded after being diagnosed with a spondylolysis, 34 patients remained for analysis. Both groups experienced significant improvement over time in all measures. There were no differences between groups for pain, PSFS, or GROC scores. No increased risk of adverse reaction from lumbar manipulation was noted. Discussion: The addition of lumbar manipulation to exercise did not benefit adolescents with acute LBP. There was not an increased risk of an adverse reaction noted in this study from lumbar manipulation performed on adolescents. Further research needs to be done to identify factors that predict positive outcomes following lumbar manipulation in adolescents.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • No
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

Lumbar manipulation adds no benefit to exercise in pain-rating or function in adolescents aged 13-17 with acute mechanical low back pain at 1 week, 4 week, and 6 month follow-ups.

Key Finding #2

At 6-month follow-up, 65% of patients in both groups still had LBP or had a recurrence of symptoms.

Key Finding #3

13 of 31 patients sought additional treatment for LBP symptoms after the 4 weeks of exercise ended.

Key Finding #4

Outcomes measures of PSFS, pain, and GROC are not established in the adolescent population.

 

Please provide your summary of the paper

This article studied the effects of lumbar manipulation with exercise, compared to sham manipulation with exercise in adolescents with mechanical LBP with duration of symptoms <90 days. The study used patient-specific functional scale (PSFS), numeric pain-rating scale (NPRS), and GROC to determine outcomes. The physical therapist performing the manipulation was different than exercise therapist and both the exercise therapists and patients were blinded   The results showed that the addition of lumbar manipulation to exercise did not benefit adolescence with acute LBP, though there is no increased risk of an adverse reaction from lumbar manipulation. A limitation to this study is that the MCIDs of NPRS, PSFS and GROC have not been established in the adolescent population. Additionally, only one type of manual therapy was prescribed.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

Seeing that both groups had unresolved LBP despite exercise interventions, future research should focus on reducing acute and long-term LBP in adolescents. Furthermore, the author states that they have experienced a population of adolescents that benefit from lumbar manipulation for the duration of the treatment session, suggesting that we should not fully negate the option of lumbar manipulation for pain reduction.

Author Names

Daniels, C., Cupler, Z., Gliedt, J., Walters, S., Schielke, A., Hinkeldey, N., Golley, D., & Hawk, C.

Reviewer Name

Sarah Stokes, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Abstract  Background and Purpose  Pain and disability may persist following lumbar spine surgery and patients may subsequently seek providers trained in manipulative and manual therapy (MMT). This systematic review investigates the effectiveness of MMT after lumbar surgery through identifying, summarizing, assessing quality, and grading the strength of available evidence. Secondarily, we synthesized the impact on medication utilization, and reports on adverse events.  Methods  Databases and grey literature were searched from inception through August 2020. Article extraction consisted of principal findings, pain and function/disability, medication consumption, and adverse events.  Results  Literature search yielded 2025 articles,117 full-text articles were screened and 51 citations met inclusion criteria.  Conclusion  There is moderate evidence to recommend neural mobilization and myofascial release after lumbar fusion, but inconclusive evidence to recommend for or against most manual therapies after most surgical interventions. The literature is primarily limited to low-level studies. More high-quality studies are needed to make recommendations.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses

  1. Is the review based on a focused question that is adequately formulated and described?
  • Yes
  1. Were eligibility criteria for included and excluded studies predefined and specified?
  • Yes
  1. Did the literature search strategy use a comprehensive, systematic approach?
  • Yes
  1. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?
  • Yes
  1. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?
  • Yes
  1. Were the included studies listed along with important characteristics and results of each study?
  • Yes
  1. Was publication bias assessed?
  • Yes
  1. Was heterogeneity assessed? (This question applies only to meta-analyses.)
  • Cannot Determine, Not Reported, Not Applicable

 

Key Finding #1

There is a lack of quality research regarding the use of manual and manipulative  therapy following lumbar surgery, so no conclusions about its efficacy can be drawn from the existing literature.

Key Finding #2

No significant adverse events from the use of manual therapy following lumbar surgery were found in any of the studies.

Key Finding #3

Some evidence suggests that following a lumbar fusion surgery, patients benefit more from a combination of neural mobilization and stabilization exercise than a combination of myofascial release and stabilization exercises or solely stabilization exercises.

 

Please provide your summary of the paper

Manual therapy is commonly used in the treatment of chronic low back pain, however there is a lack of consensus on the use of manual therapy for post-surgical patients. The authors sought to evaluate the current research regarding the use of manual therapy in patients post-lumbar surgery through a systematic review. 51 studies were reviewed including case reports, randomized control trials, systematic reviews, narrative reviews, and cross-sectional surveys. Findings were grouped by type of lumbar surgery. A lack of quality research specific to the use of manual therapy following discectomies, disc replacements, and lumbar fusion made it difficult to create recommendations for or against the use of manual therapy following these procedures. For laminectomy, one randomized control trial found that grade 3 or 4 mobilizations post-surgery increase lumbar extension ROM but had no effect on pain or function. However, there is no other evidence available for laminectomies, so no conclusions can be drawn based on this one study. For lumbar fusion, there is some evidence to suggest that neural mobilizations in conjunction with stabilization exercises has a greater effect than myofascial release in conjunction with stabilization exercises or stabilization exercises alone. There is no evidence, however, for the use of manual or manipulative therapies following lumbar fusion.  Overall, the lack of research on this topic makes it difficult for any recommendations for or against the use of manual therapy for patient post-spinal surgery and identifies an area in need of further research in the profession.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

There is a significant gap in the literature regarding the use of manual and manipulative therapies for patients who have had lumbar surgeries. This is important research to have because many of the individuals who undergo these procedures will have recurrence of chronic low back pain post-surgery. Some of the low-level studies suggest that manual therapy could be a viable pain management strategy for this population, but more research is needed to draw any conclusions. While there is a CPG for chronic low back pain, there are no existing guidelines for the treatment of this special sub-section of the chronic low back pain population regarding the use of manual therapy. One positive finding from the current research is that of all 51 studies included in this systematic review, none had any adverse events following the application of manual therapy. This means, at the very least, manual therapy is not significantly harmful to this population. The use of manual therapy for the treatment of patients post-lumbar surgery lacks high-quality research and no findings from this paper can be applied to clinical practice. This topic must be investigated further in order to determine how to best treat this patient population.

Author Names

Kamali, F. and Shokri, E.

Reviewer Name

Kiara Smith, LAT, ATC, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Summary  Objectives To compare the effect of sacroiliac joint (SIJ) manipulation with SIJ and lumbar manipulation for the treatment of SIJ syndrome.  Methods Thirty-two women with SIJ syndrome were randomly divided into two groups of 16 subjects. One group received the high-velocity low-amplitude (HVLA) manipulation to the SIJ and the other group received both SIJ and lumbar HVLA manipulation to both the SIJ and lumbar spine in a single session. The outcomes were assessed using visual analogue scale (VAS) at baseline, immediately, 48 h and one month after the treatment for pain and also Oswestry Disability Index (ODI) questionnaire at baseline, 48 h and one month after the treatment.  Results Analysis revealed a statistically significant improvement immediately, at 48 h and one month after treatment for pain and significant improvement at 48 h and one month after treatment for functional disability in the SIJ manipulated group. A significant improvement immediately, at 48 h and one month after treatment for pain and significant improvement at 48 h and one month after treatment for functional disability in the SIJ and lumbar manipulated group was also found. Furthermore, there were significant differences within groups in ODI and VAS when using Friedman test in both groups. By using Wilcoxon rank sum test no differences were observed in change scores between the two groups immediately, 48 h and one month after the treatment for VAS, or after 48h and one month after the treatment for the ODI.  Conclusion A single session of SIJ and lumbar manipulation was more effective for improving functional disability than SIJ manipulation alone in patients with SIJ syndrome. Spinal HVLA manipulation may be a beneficial addition to treatment for patients with SIJ syndrome.

NIH Risk of Bias Tool

Quality Assessment Tool for Before-After (Pre-Post) Studies With No Control Group

  1. Was the study question or objective clearly stated?
  • Yes
  1. Were eligibility/selection criteria for the study population prespecified and clearly described?
  • Yes
  1. Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest?
  • Yes
  1. Were all eligible participants that met the prespecified entry criteria enrolled?
  • No
  1. Was the sample size sufficiently large to provide confidence in the findings?
  • No
  1. Was the test/service/intervention clearly described and delivered consistently across the study population?
  • Yes
  1. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ exposures/interventions?
  • No
  1. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis?
  • Cannot Determine, Not Reported, Not Applicable
  1. Did the statistical methods examine changes in outcome measures from before to after the intervention? Were statistical tests done that provided p values for the pre-to-post changes?
  • Yes
  1. Were outcome measures of interest taken multiple times before the intervention and multiple times after the intervention (i.e., did they use an interrupted time-series design)?
  • No
  1. If the intervention was conducted at a group level (e.g., a whole hospital, a community, etc.) did the statistical analysis take into account the use of individual-level data to determine effects at the group level?
  • Cannot Determine, Not Reported, Not Applicable

 

Key Finding #1

BOTH lumbar and SIJ manipulations are unnecessary when treating SIJ dysfunction as SIJ manipulations alone can produce the same results without altering the mechanics of the lumbar spine.

Key Finding #2

There was a significant improvement in pain (via VAS) and functional disability (via ODI) in both groups when assessed 48 hours after treatment and one month after treatment.

Key Finding #3

Spinal HVLA manipulation may be a beneficial addition when treating SIJ dysfunction.

Key Finding #4

One session of SIJ manipulation can produce the same degree of improvement as multiple sessions of joint manipulation treatments.

 

Please provide your summary of the paper

The study examined the efficiency of using two manipulative therapy techniques to treat SIJ dysfunction. Researchers took a sample of 30 women, ages 20-30, and randomly assigned them to two groups. The first group received an HVLA manipulation to the SIJ while the other groups received both SIJ and lumbar HVAL manipulation. Previous research suggested that due to the relationship between the lumbar spine and the sacroiliac joint, the lumbar spine should be manipulated before implementing any SIJ manipulations. It was suggested that the involvement of one structure would affect the positioning and mobility of the other structure. Researchers assessed pain (via VAS) and functional disability (via ODI) before treatment as well as 48 hours post-treatment and one month post-treatment. Results of the study suggested that implementing both lumbar and SIJ manipulations is not necessary when treating SIJ dysfunction. Both groups saw clinically significant improvements in both pain and functional disability and there was no statistically significant difference between the two groups. This study did not consist of a control group therefore it can not serve as proof of the clinical efficacy of using spinal manipulation to treat SIJ. The small sample size and lack of diversity in patient demographics do not help improve the understanding of SIJ dysfunction and its treatment across various patient populations.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This study encourages clinicians to think about whether or not they are over-treating their patients. It also provides insight into the short-term benefits of implementing manipulative therapy when treating SIJ dysfunction. The exclusion criteria of this study included patients who had joint manipulation performed previously to help mitigate the placebo effect. While the treatments did show significant improvements, clinicians should also consider that there are other plausible explanations as to why participants saw improvements. The lack of a control group and long-term follow-up do not provide insight into the long-term effectiveness of manipulation-only-based treatment. Therefore, we cannot assess how these results would compare to exercise-based treatments both short-term and long-term in a similar population.

Author Names

Franke, H., Franke, J., Belz, S., Fryer, G.

Reviewer Name

Joy Senkungu, SPT

Reviewer Affiliation(s)

Duke University School of Medicine Department of Physical Therapy

Paper Abstract

Background Low back pain (LBP) is a common complaint during pregnancy. This study examined the effectiveness of osteopathic manipulative treatment (OMT) for LBP in pregnant or postpartum women.  Methods Randomized controlled trials unrestricted by language were reviewed. Outcomes were pain and functional status. Mean difference (MD) or standard mean difference (SMD) and overall effect size were calculated.  Results Of 102 studies, 5 examined OMT for LBP in pregnancy and 3 for postpartum LBP. Moderate-quality evidence suggested OMT had a significant medium-sized effect on decreasing pain (MD, −16.65) and increasing functional status (SMD, −0.50) in pregnant women with LBP. Low-quality evidence suggested OMT had a significant moderate-sized effect on decreasing pain (MD, −38.00) and increasing functional status (SMD, −2.12) in postpartum women with LBP.  Conclusions This review suggests OMT produces clinically relevant benefits for pregnant or postpartum women with LBP. Further research may change estimates of effect, and larger, high-quality randomized controlled trials with robust comparison groups are recommended.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses

  1. Is the review based on a focused question that is adequately formulated and described?
  • Yes
  1. Were eligibility criteria for included and excluded studies predefined and specified?
  • Yes
  1. Did the literature search strategy use a comprehensive, systematic approach?
  • Yes
  1. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?
  • Yes
  1. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were the included studies listed along with important characteristics and results of each study?
  • Yes
  1. Was publication bias assessed?
  • Yes
  1. Was heterogeneity assessed? (This question applies only to meta-analyses.)
  • Yes

Key Finding #1

Osteopathic manual therapy improves low back pain and functional status in postpartum women.

Key Finding #2

Osteopathic manual therapy can be beneficial and there have been minor adverse effects seen through one study, although more research should be done on longevity of results.

 

Please provide your summary of the paper

This study was a systematic review of osteopathic manipulative therapy during and after pregnancy on the low back and pelvic girdle pain. It found that there was a significant improvement in both pain and function in the low back for pregnant women as well as postpartum. Overall greater research is needed for longer periods of time in order to increase the quality of evidence needed to solidify longterm effects.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This paper may impact clinical practice minimally due to a lack of follow-up results. More research would need to be done to see the longevity of decreased pain and increased function in both pregnant women and those who are postpartum. Because there are not many adverse effects and some significant findings, these results can be applied to cases where OMT may be beneficial.

Author Names

Short, S., Short, G., Strack, D., Anloague, P., & Brewster, B.

Reviewer Name

Arienne Sauvignon Howard LAT, ATC, SPT

Reviewer Affiliation(s)

Student within Duke’s Doctorate of Physical Therapy Program Class of 2025

Paper Abstract

Background/Purpose Athletes experiencing hip, groin, and low back pain often exhibit similar clinical characteristics. Individuals with hip, groin and low back pain may have the presence of multiple concurrent pathoanatomical diagnoses. Regardless, similar regional characteristics and dysfunction may contribute to the patient’s chief complaint, potentially creating a sub-group of individuals that may be defined by lumbopelvic and hip mobility limitations, motor control impairments, and other shared clinical findings. The purpose of this case series is to describe the conservative management of elite athletes, within the identified aforementioned sub-group, that emphasized regional manual therapy interventions, and therapeutic exercise designed to improve lumbopelvic and hip mobility, stability and motor control. Case Descriptions Five elite athletes were clinically diagnosed by a physical therapist with primary pathologies including adductor-related groin pain (ARGP), femoral acetabular impingement (FAI) with acetabular labral lesion and acute, mechanical low back pain (LBP). Similar subjective, objective findings and overall clinical profiles were identified among all subjects. Common findings aside from the chief complaint included, but were not limited to, decreased hip range of motion (ROM), impaired lumbopelvic motor control and strength, lumbar hypomobility in at least one segment, and a positive hip flexion-adduction-internal rotation (FADIR) special test. A three-phase impairment-based physical therapy program was implemented to resolve the primary complaints and return the subjects to their desired level of function. Acute phase rehabilitation consisted of manual therapy and fundamental motor control exercises. Progression to the sub-acute and terminal phases was based on improved subjective pain reports and progress with functional impairments. As the subjects progress through the rehabilitation phases, the delivery of physical therapy interventions were defined by decreased manual therapies and an increased emphasis and priority on graded exercise. Outcomes Significant reductions in reported pain (>2 points Numeric Pain Rating Scale), improved reported function via functional outcome measures (Hip and Groin Outcome Score), and continued participation in sport occurred in all five cases without the need for surgical intervention. Discussion The athletes described in this case series make up a common clinical sub-group defined by hip and lumbopelvic mobility restrictions, lumbopelvic and lower extremity motor control impairments and potentially other shared clinical findings. Despite differences in pathoanatomic findings, similar objective findings were identified, and similar treatment plans were applied, potentially affecting the movement system as a whole. Subjects were conservatively managed allowing continued participation in sport within their competitive seasons. Conclusion Comprehensive conservative treatment of the athletes with shared impairments, as described in this case series, may be of clinical importance when managing athletes with hip, groin, and low back pain.

 

NIH Risk of Bias Tool

Quality Assessment of Case-Control Studies

  1. Was the study question or objective clearly stated?
  • Yes
  1. Was the study population clearly and fully described, including a case definition?
  • Yes
  1. Were the cases consecutive?
  • Yes
  1. Were the subjects comparable?
  • Yes
  1. Was the intervention clearly described?
  • Yes
  1. Were the outcome measures clearly defined, valid, reliable, and implemented consistently across all study participants?
  • Yes
  1. Was the length of follow-up adequate?
  • No
  1. Were the statistical methods well-described?
  • Yes
  1. Were the results well-described?
  • Yes

 

Key Finding #1

By the completion of the 3-phase program, reduction within reported pain was noted by greater than 2 points via the Numeric Pain Rating Scale. Improved reported function was detected via functional outcome measures such as Hip and Groin Outcome Score. Return to sport including continued participation within the respective seasons occurred for all 5 cases.

Key Finding #2

By the 2nd phase of the 3-phase rehabilitation program; the Sub Acute phase, 4 out of the 5 subjects returned to sport participation and/or competition. “All subjects were managed conservatively within their competitive seasons and training cycles. Players were able to maintain sport performance at or above their prior levels of function with significant reductions in reported pain upon returning to participation and competition” (Short, S. et al. 2017).

Key Finding #3

Subject Response To Manual Therapy:

  • Subject 1- The application of soft tissue mobilization and dry needling resulted in reports of decreased groin ‘tightness’ and overall pain reductions on the Numeric Pain Rating Scale. In addition to this, along the course of the 3-phase rehabilitation program, graded hip mobilization was introduced which resulted in decreased pain with single leg squatting.
  • Subject 2- Responded well to soft tissue mobilization as well as graded joint mobilization of the lumbar spine that resulted in the improved capability of abdominal drawing-in exercises, which decreased reported pain in the groin.
  • Subject 3- The application of spinal manipulation and graded lumbar mobilization resulted in visual and palpable improvements in motor control during the performance of a posterior pelvic tilt. These manipulations and mobilizations also provided a decrease in the patient’s report of ‘pinching’ in his groin during the performance of a double leg squat and forward lunge. In addition to this, along the course of the 3-phase rehabilitation program, hip joint mobilization and using mobilization with movement techniques along with soft tissue mobilizations resulted in pain-free performance of the double leg squat, forward lunge and single leg squat.
  • Subject 4- The application of spinal manipulation and graded lumbar and hip mobilizations were utilized throughout the 3-phase rehabilitation program.
  • Subject 5- The application of soft tissue mobilization, hip mobilization with movement, followed by a long axis hip thrust manipulation, and supine lumbopelvic manipulation technique resulted in immediate reduction in both his inferior lumbar and medial hip symptoms.

 

Please provide your summary of the paper

A combined treatment approach emphasizing impairment- based manual therapy and exercise for hip-related compensatory injury in elite athletes: A case series.” by Short, S. et al. ( 2017), was based on five male athletes between the ages of 19-27 years-old who participate in contact sports varying between collegiate to the professional level that have been experiencing signs/symptoms of discomfort within the low back, hip and/or groin. In addition to common findings regarding the chief complaints, additional examinations included palpation, range of motion, strength assessment and special test all of which confirmed correlation between each subject as they had similar diagnoses. With the information gathered during the beginning of examination, a three-phase rehabilitation program was developed and implemented as a comprehensive conservative treatment approach to assist in return to sport for each subject within their respective seasons. Within each phase the incorporation of exercise and manual therapy was utilized to ensure improvements with lumbopelvic and hip mobility, stability, and motor control. By the end of the program, reduction within reported pain was noted by greater than 2 points via the Numeric Pain Rating Scale, improved reported function was detected via functional outcome measures such as Hip and Groin Outcome Score, and return to sport including continued participation occurred for all 5 cases. Though return to sport occurred with subjects missing at least 1 game and practice to at most subjects returning 12-weeks post-injury, during the 1 year follow up it was recognized that 2 out of the 5 subjects encountered re-injury 6 months to a year following the completion of the 3-phase rehabilitation program.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The study presented within the article, “A combined treatment approach emphasizing impairment- based manual therapy and exercise for hip-related compensatory injury in elite athletes: A case series.” by Short, S. et al. (2017), impacts clinical practice by giving insight on how to approach similar instances in the future more effectively by understanding what worked and what could have been done better in respect to treatment of elite athletes. Expanding on this insight allows for clinicians to take a more targeted approach towards allowing for the success of conservative management of elite athletes (within the identified aforementioned sub-group) with an emphasis on regional manual therapy interventions and therapeutic exercise designed to improve lumbopelvic and hip mobility, stability, and motor control.

Regarding execution, results can be implemented via recognition of two important key components; addressing the body as a whole and continuation of rehabilitation/intervention after signs/symptoms have subsided. Addressing the body as a whole and not just focusing on what or how the patient presents themselves is pivotal as “asymptomatic findings and concurrent pathoanatomical diagnosis make treating specific structures challenging” and complex. For instance, for those who had chronic pathologies within the study, taking into consideration biomechanics as well as other coexisting diagnoses are crucial factors as they can also be why/how the patient presents themselves. Furthermore, ensuring the continuation of rehabilitation is important to warrant the prevention of injury recurrence as already stated in the article “once symptoms are improved, continuing an individualized program may be beneficial in further reducing this risk” Short, S. et al. (2017).

Author Names

Deodato, M., Grosso, G., Drago, A., Martini, M., Dudine, E., Murena, L., & Buoite Stella, A.

Reviewer Name

Roxanne Ruther, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Physical Therapy Division

Paper Abstract

Background: Primary dysmenorrhea represents one of the most common causes of pelvic and low back pain. Pharmacological treatment can present some side effects, and non-pharmacological treatments should be considered to improve the symptoms of primary dysmenorrhea. The aim of this study was to evaluate the efficacy of manual therapy (MT), pelvic floor exercises (PFE), and their combination (MT + PFE) to improve clinical outcomes and pain sensitivity in women with primary dysmenorrhea.  Methods: A prospective observational study was conducted. Thirty females (age 25.0 ± 6.1 y) with history of primary dysmenorrhea participated to 8 sessions of 60 min of either MT, PFE or MT + PFE, twice per week. They participated to the different treatments according to the different services offered by the school of physiotherapy. A 0–10 numeric rating scale (NRS) was administered to assess subjective pain, while short-form 36 (SF-36) was used to evaluate quality of life. The pressure pain threshold (PPT) was assessed with a portable algometer on different pelvic and lumbar areas. Results: Independently from the treatment, significant improvements were reported for general pain NRS (p &lt; 0.001; pη2 = 0.511), as well as most the domains of the SF-36, although the general health domain did not reach statistical significance (p = 0.613; pη2 = 0.010). PPT revealed a general improvement in all tested body areas, although on the quadratus lumborum, the PFE treatment did not induce a significant improvement compared to the MT and MT + PFE protocols (p = 0.039). Conclusions: These findings highlight the importance of proposing physiotherapy treatments to females with primary dysmenorrhea to improve symptoms, with manual therapy combined with active pelvic floor exercise providing the best outcomes including an improvement of lumbar pain thresholds.

NIH Risk of Bias Tool

Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies

  1. Was the research question or objective in this paper clearly stated?
  • Yes
  1. Was the study population clearly specified and defined?
  • Yes
  1. Was the participation rate of eligible persons at least 50%?
  • Yes
  1. Were all the subjects selected or recruited from the same or similar populations (including the same time period)? Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants?
  • Yes
  1. Was a sample size justification, power description, or variance and effect estimates provided?
  • Cannot Determine, Not Reported, Not Applicable
  1. For the analyses in this paper, were the exposure(s) of interest measured prior to the outcome(s) being measured?
  • Yes
  1. Was the timeframe sufficient so that one could reasonably expect to see an association between exposure and outcome if it existed?
  • Yes
  1. For exposures that can vary in amount or level, did the study examine different levels of the exposure as related to the outcome (e.g., categories of exposure, or exposure measured as continuous variable)?
  • No
  1. Were the exposure measures (independent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?
  • Yes
  1. Was the exposure(s) assessed more than once over time?
  • Yes
  1. Were the outcome measures (dependent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?
  • Yes
  1. Were the outcome assessors blinded to the exposure status of participants?
  • Yes
  1. Was loss to follow-up after baseline 20% or less?
  • Yes
  1. Were key potential confounding variables measured and adjusted statistically for their impact on the relationship between exposure(s) and outcome(s)?
  • Yes

 

Key Finding #1

According to an analysis of subjective rating of pain, improvements in pelvic, lumbar and general pain were unanimous for all three treatment groups, pelvic floor exercises, manual therapy and combination of both.

Key Finding #2

Use of the pain pressure threshold revealed that pelvic floor exercises were less effective than the other treatment groups in reducing pain threshold in lumbar muscles.

Key Finding #3

The largest magnitude of change in symptoms was indicated in the combination treatment group, despite the treatment time split evenly between manual therapy and pelvic floor exercises.

 

Please provide your summary of the paper

Women with a history of primary dysmenorrhea were randomly assigned to pelvic floor exercise, manual therapy and combination treatment groups. Treatment was provided twice a week for four weeks. Manual therapy treatment included diaphragm mobilization, myofascial release on the internal side of the ischial tuberosities, and post-isometric release exercise with tender point therapy of TFL, piriformis, and lumbar paravertebrals. Exercise was focused on improving proprioception and isolated control of the pelvic floor, as well as improving respiratory muscle control. Pain and quality of life were evaluated using the numeric rating scale and SF-36, in combination with the pain pressure threshold for pelvic and lumbar areas. Pelvic floor exercises and manual therapy treatment significantly improve symptoms of pain and quality of life.  Every treatment group demonstrated reduction of pain in overall rating, as well as pelvic and lumbar regions. The combination of both treatment techniques contributes to the best outcomes in the reduction of lumbar pain.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The use of pelvic floor exercise and manual therapy is relevant to the treatment of lumbar and pelvic pain resulting from primary dysmenorrhea. Both manual therapy techniques and pelvic floor exercise should be utilized to target the lumbopelvic region and respiratory musculature. A multi-faceted approach to pelvic and lumbar pain is most effective in reduction of symptoms and patient perception of pain. Because the duration was four weeks, additional data are required to draw conclusions about long-term improvements for women with primary dysmenorrhea.

Author Names

Hicks, G. E., George, S. Z., Pugliese, J. M., Coyle, P. C., Sions, J. M., Piva, S., Simon, C. B., Kakyomya, J., & Patterson, C. G.

Reviewer Name

Ciara Roche, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background

Previously, we identified a population of older adults with chronic low back pain, hip pain, and hip muscle weakness who had worse 12-month low back pain and functional outcomes than age-matched adults with only low back pain, indicating an increased risk for future mobility decline. We sought to determine whether tailored, hip-focused physical therapy reduced pain and functional limitations in this high-risk population compared with non-tailored, spine-focused physical therapy.

Methods

We did a multicentre, single-masked, randomised controlled trial at three research-based sites in the USA. We recruited older adults (aged 60–85 years) with hip pain and weakness who reported moderate low back pain intensity at least half the days in the last 6 months. Patients were randomly assigned to hip-focused physical therapy or spine-focused physical therapy using permuted blocks with random block size, stratified by site and sex (ie, male or female). The primary outcomes were self-reported disability using the Quebec Back Pain Disability Scale (QBPDS) and performance-based 10-Meter Walk Test (10MWT) at 8 weeks. All analyses were done in the intention-to-treat population. Adverse events were collected by study staff via a possible adverse event reporting form and then adjudicated by site investigators. This trial was registered with ClinicalTrials.gov, NCT04009837.

Findings

Between Nov 1, 2019, and April 30, 2022, 184 participants were randomly assigned to receive hip-focused (n=91) or spine-focused physical therapy (n=93) interventions. The mean age was 70·7 (SD 6·2) years. 121 (66%) of 184 participants were women, 63 (34%) were men, and 149 (81%) were White. At 8 weeks, the mean between-group difference on the QBPDS was 4·0 (95% CI 0·5 to 7·5), favouring hip-focused physical therapy. Both groups had similar, clinically meaningful gait speed improvements (10MWT) at 8 weeks (mean difference 0·004 m/s [95% CI –0·044 to 0·052]). No serious adverse events were related to study participation.

Interpretation

Tailored hip-focused physical therapy demonstrated greater improvements in low back pain-related disability at 8 weeks. However, both hip-focused physical therapy and spine-focused physical therapy produced clinically meaningful improvements in disability and function for this high-risk population at 6 months. These findings warrant further investigation before clinical implementation.

Funding

US National Institute on Aging of the National Institutes of Health.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

Hip-focused interventions may be more beneficial for short-term pain improvement in older adults with chronic low back pain.

Key Finding #2

Hip-focused interventions may be more beneficial in improving lower extremity strength and endurance in older adults with chronic low back pain.

Key Finding #3

Both hip- and spine-focused interventions may be beneficial in improving functioning of older adults with chronic low back pain.

Key Finding #4

Hip-focused interventions may be more beneficial for short-term improvement in low back pain related disability in older adults with chronic low back pain.

 

Please provide your summary of the paper

This study aimed to investigate how older adults with chronic low back pain who are at risk for functional decline respond to different physical therapy interventions. This study was significant because much of the existing research on low back pain interventions studies the adult population, not older adults. Older adults are at a higher risk of chronic pain and subsequent decrease in function, therefore it is important for physical therapists to identify and implement the treatment strategy with the greatest improvement in outcomes. This randomized controlled trial compared hip-focused interventions with spine-focused interventions including a combination of manual therapy and exercise.  Men and women aged 60-85 years with chronic moderate low back pain, hip pain, and hip weakness were included. The primary outcomes assessed were Quebec Back Pain Disability Scale and 10-Meter Walk Test, and they were assessed at baseline, 8 weeks, and 6 months. All participants were seen for intervention sessions 2 times per week for 8 weeks. The hip-intervention group received manual therapy to each hip including long axis distraction, mobilizations in all directions, and manual stretching to the hip flexors and hamstrings. They participated in functional hip exercises including partial wall squats, hip abduction with elastic band, forward step-ups, wall squats, side-stepping with band, and lateral step-ups. Finally, their home exercise program consisted of hip strengthening in abduction, extension, internal rotation and external rotation with an elastic band, and trunk muscle training exercises such as bracing, curl-ups, side bridges, and alternating arm lifts in quadruped. The spine-intervention group received manual therapy to the lumbar spine including P-A mobilizations and effleurage. They participated in trunk muscle training exercises such as bracing, curl-ups, alternating arm lifts in quadruped, and stationary cycling without resistance. Their home exercise program consisted of general lumbar flexibility stretches, bracing, curl-ups, and alternating arm lifts in quadruped. Both groups received moist heat during HEP education at the end of each session. Secondary physical performance measures including 6-Minute Walk Test, 30-Second Chair Stand Test, and Timed Up and Go were also assessed at baseline and the two follow-up assessments. Self-report questionnaires, Low Back Activity Confidence Scale, the Pain Catastrophizing Scale, hip isometric strength, and Quantitative Sensory Testing were also collected at each assessment.  At 8 weeks, the hip-intervention group had statistically significantly higher improvements in self-reported disability and 6-MWT distance than the spine-intervention group. At 6 months, the hip-intervention group had statistically significantly higher improvements in 6-MWT and 30SCST than the spine-intervention group. The hip-intervention group also had higher improvements in self-reported pain and pain interference measures at 8 weeks.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

Although many of the outcomes favored the hip-focused intervention group at the 8-week follow up assessment but not at the 6-month follow up assessment, both groups continued to improve from 8-weeks to 6-months, indicating that both hip- and spine-focused interventions may produce favorable outcomes in the population that was studied. Hip-focused interventions may provide quicker short-term improvements, but more research is necessary to determine if clinically significant improvements are made earlier than the 8-week timepoint. The results of this study can guide physical therapists in treating this population: a combination of manual therapy and exercise during a plan of care 2 times per week for 8 weeks should result in improved pain, self-selected gait speed, strength and functioning at 6 months from baseline. These findings cannot be extrapolated to individuals with cognitive impairment, rheumatoid arthritis, artificial hip joint, or red flag symptoms, or who are wheelchair users, as they were excluded from the study.

Author Names

Didehdar, D., Kamali, F., Yoosefinejad, A.K., Lotfi, M.

Reviewer Name

Maggie Quarles, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: In patients with chronic nonspecific low back pain (NCLBP), brain function changes due to the neuroplastic changes in different regions. Aim: The current study aimed to evaluate the brain metabolite changes after spinal manipulation, using proton magnetic resonance spectroscopy (1 H-MRS). Methods: In the current study, 25 patients with NCLBP aged 20–50 years were enrolled. Patients were randomly assigned to lumbopelvic manipulation or sham. Patients were evaluated before and 5 weeks after treatment by the Numerical Rating Scale (NRS), the Oswestry Disability Index (ODI), and 1 H-MRS. Results: After treatment, severity of pain and functional disability were significantly reduced in the treatment group vs. sham group (p &lt; 0.05). After treatment, N-acetyl aspartate (NAA) in thalamus, insula, dorsolateral prefrontal cortex (DLPFC) regions, as well as choline (Cho) in the thalamus, insula, and somatosensory cortex (SSC) regions, had increased significantly in the treatment group compared with the sham group (p &lt; 0.05). A significant increase was further observed in NAA in thalamus, anterior cingulate cortex (ACC), and SCC regions along with Cho metabolite in thalamus and SCC regions after treatment in the treatment group compared with the baseline measures (p &lt; 0.05). Also, a significant increase was observed in Glx (glutamate and glutamine) levels of thalamus (p = 0.03). There was no significant difference in terms of brain metabolites at baseline and after treatment in the sham group. Conclusion: In the patient with low back pain, spinal manipulation affects the central nervous system and changes the brain metabolites. Consequently, pain and functional disability are reduced.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • No
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

Spinal manipulation can increase brain metabolite concentration in specific areas of the brain, which can help reduce pain.

Key Finding #2

5 weeks following intervention, the group who received spinal manipulation reported less disability compared to the “sham” group.

 

Please provide your summary of the paper

This study examined the impact of spinal manipulation on brain metabolite activity, and the resultant effect on pain and functional disability. The study randomly assigned 25 participants to an intervention group (10 participants) and a sham group (15 participants). The intervention group received 3 sessions of lumbar and sacroiliac thrust manipulations, while the sham group received 3 sessions with similar positions to the manipulations, without receiving the actual thrust technique. The results concluded that after 5 weeks, the patients in the intervention group had increased brain metabolite concentration in the thalamus, and reported less pain and functional disability, measured by the Numerical Rating Scale (NRS) and Oswestry Disability Index (ODI). There were no significant differences in pain and disability rating in the sham group.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This is the first study to look at brain metabolite activity after lumbopelvic manipulation in patients with non-specific low back pain. The results of the study help to reveal that spinal manipulation can impact the CNS, which can result in a significant impact on pain and disability. One drawback to this study is the small sample size, but overall the conclusions can be useful in the utilization of manual therapy in patients with low back pain.

Author Names

Molins-Cubero, S., Rodríguez-Blanco, C., Oliva-Pascual-Vaca, A., Heredia-Rizo, A.M., Boscá-Gandía, J.J., Ricard, F.

Reviewer Name

Michelle Metzger, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective: This study aims to evaluate the immediate effect of a global pelvic manipulation (GPM) technique, bilaterally applied, on low back pelvic pain in women with primary dysmenorrhea (PD). Design: A prospective, randomized, double-blind, controlled trial. Setting: Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Spain. Methods: The sample group included 40 women (30 ± 6.10 years) that were divided into an experimental group (EG) (N = 20) who underwent a bilateral GPM technique and a control group (CG) (N = 20) who underwent a sham (placebo) intervention. Evaluations were made of self-reported low back pelvic pain (visual analog scale), pressure pain threshold (PPT) in sacroiliac joints (SIJs), and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels. Results: The intragroup comparison showed a significant improvement in the EG in the self-perceived low back pelvic pain (P = 0.003) and in the mechanosensitivity in both SIJs (P = 0.001). In the between-group comparison, there was a decrease in pain perception (P = 0.004; F(1,38) = 9.62; R(2) = 0.20) and an increase in the PPT of both SIJs, in the right side (P = 0.001; F(1,38) = 21.29; R(2) = 0.35) and in the left side (P = 0.001; F(1,38) = 20.63; R(2) = 0.35). There were no intergroup differences for catecholamines plasma levels (adrenaline P = 0.123; noradrenaline P = 0.281; dopamine P = 0.173), but there were for serotonin levels (P = 0.045; F(1,38) = 4.296; R(2) = 0.10). Conclusion: The bilateral GPM technique improves in a short term the self-perceived low back pelvic pain, the PPT in both SIJs, and the serotonin levels in women with PD. It shows no significant differences with a sham intervention in catecholamines plasma levels.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

The global pelvic manipulation thrust technique applied bilaterally resulted in decreased short-term self-perceived low back pain compared to the control group for people experiencing primary dysmenorrhea.

Key Finding #2

Pain pressure threshold for both Sacroiliac Joints increased on both sides for those who received the thrust technique, while those in the control group showed a decrease in pain pressure threshold on the left side.

Key Finding #3

Those who received the thrust technique showed higher levels of adrenaline, serotonin, and dopamine and reduced levels of noradrenaline after receiving the intervention compared to the control group.

Key Finding #4

The global pelvic manipulation thrust technique resulted in positive changes related to pain compared to the control group when tested immediately after receiving the intervention suggesting short-term changes.

 

Please provide your summary of the paper

This study examined the efficacy of a global pelvic manipulation thrust technique applied bilaterally for the treatment of patients experiencing primary dysmenorrhea. The results demonstrated that participants who received the thrust technique had decreased short-term self-perceived low back pain (measured with VAS), increased pain pressure threshold for both sides of the Sacroiliac Joint (measured with a digital dynamometer), and higher levels of adrenaline, serotonin, and dopamine and reduced levels of noradrenaline (measured through blood extraction). These results suggest global pelvic manipulation thrusts may be a viable treatment option for the short-term in this population and are effective at modulating pain.  However, it should be noted that the change in VAS score did not meet the VAS MDC value likely due to the low baseline VAS score for participants. This study examined only the immediate effects of the thrust manipulation and therefore no long-term effects can be described. While short-term effects are important to assess, long-term effects should be considered in future studies. This study was also limited by the lack of control of subject’s intake of NSAIDs and/or clyclo-oxygenase-2 specific inhibitors, as well as oral contraceptives (all of which can influence pelvic pain levels). Furthermore, patient’s comfortability and fear of spinal manipulation and blood extraction and their recent food intake, stress level, and circadian rhythm could have impacted catecholamines and serotonin plasma levels.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This study supports the use of the global pelvic manipulation thrust technique applied bilaterally when treating patients with primary dysmennorhea for short-term results. This is important considering the most common therapeutic approach is medical management with NSAIDs and oral contraceptives, which may involve adverse side effects. While the long-term effects of this technique are not currently known, it is a quick and simple treatment with immediate effects that can help decrease pain during the current treatment session with a lower risk of adverse effects. This technique can be used for patients being treated for pelvic concerns and those experiencing primary dysmennorhea being treated for other conditions to benefit the treatment session.

Author Names

Boff T.A, Pasinato F., Ben Â.J., Bosmans J., Tulder M., Carregaro R.

Reviewer Name

Said Mendez LAT, ATC, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Study Design: Randomized Control Trial with three months follow up. Objective: To investigate the effectiveness of spinal manipulation combined with myofascial release compared with spinal manipulation alone, in individuals with chronic non-specific low back pain (CNLBP). Participants: Seventy-two individuals (between 18 and 50 years of age; CNLBP ≥12 consecutive weeks) were enrolled and randomly allocated to one of two groups: (1) Spinal manipulation and myofascial release – SMMRG; n = 36) or (2) Spinal manipulation alone (SMG; n=36). Interventions: Combined spinal manipulation (characterized by high velocity/low amplitude thrusts) of the sacroiliac and lumbar spine and myofascial release of lumbar and sacroiliac muscles vs manipulation of the sacroiliac and lumbar spine alone, twice a week, for three weeks. Main Outcome measures: Assessments were performed at baseline, three weeks post intervention and three months follow-up. Primary outcomes were pain intensity and disability. Secondary outcomes were quality of life, pressure pain-threshold and dynamic balance. Results: No significant differences were found between SMMRG vs SMG in pain intensity and disability post intervention and at follow-up. We found an overall significant difference between-groups for CNLBP disability (SMG-SMMRG: mean difference of 5.0; 95% confidence interval of difference 9.9; −0.1), though this effect was not clinically important and was not sustained at follow-up. Conclusion: We demonstrated that spinal manipulation combined with myofascial release was not more effective compared to spinal manipulation alone for patients with CNLBP.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • No
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

Key Finding #1

There were significant improvements in pain, disability, and quality of life post intervention for both groups, but was not sustainable during the 3-month follow-up visit.

Key Finding #2

There was no significant differences in improvements of pain and quality of life in groups. However, there was significant difference between groups for disability.

Key Finding #3

The authors were unable to reject their null hypothesis that a combination of spinal manipulation and myofacial release would be superior to spinal manipulation alone.

 

Please provide your summary of the paper

This study showed that a three-week intervention program, twice a week, for participants with non-specific low back pain showed no clinically significant results between participants who received spinal manipulation and myofascial release vs spinal manipulation alone. Although there was significant improvement in pain, disability, and quality of life in both groups, post treatment, these improvements did not carry over to their three month follow up visit. Spinal manipulation has been shown to have analgesic effects within the central nervous system and, therefore, it is possible the improvements where solely due to spinal manipulation while myofascial release did not provide additional benefits. Limitations of the study that should be taken into consideration include therapists that administered the interventions were not blinded, some participants reported doing intense exercise apart from the interventions due to feeling improvement, and overall, it was a short intervention period.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This study provided some insight about using myofascial release techniques along with spinal manipulation techniques to help improve pain, disability, and quality of life in a short period of time. However, these results had no carry over to a 3-month follow-up. Physical therapists want to promote maintenance of health to help maintain independence and functional mobility. This research study further supports that therapy for non-specific low back pain is a marathon not a sprint for a patient to see sustainable improvements. Further research needs to be performed to see if a longer intervention program with appropriate home exercise programs, myofascial techniques, and spinal manipulations would provide long term maintenance of functional mobility and independence.

Author Names

Bond, B. M., Kinslow, C. D., Yoder, A. W., & Liu, W.

Reviewer Name

Bonnie Leung

Reviewer Affiliation(s)

Duke University School of Medicine, Physical Therapy Division

Paper Abstract

Objectives: The long-term goal of this study is to improve the understanding of the biological mechanisms associated with spinal manipulative therapy (SMT) in low back pain. Methods: This project involved a pilot randomized, blinded clinical trial (ClinicalTrials.gov registration number NCT03078114) of 3-week SMT in chronic nonspecific low back pain (CNSLBP) patients. Researchers recruited 29 participants and randomly assigned them into either a SMT (n = 14) or sham SMT (n = 15) group. Pre- and post intervention, we quantified the effect of SMT on clinical outcomes (Numeric Pain Rating Scale and Oswestry Disability Index) and pressure pain threshold (PPT) at local (lumbar spine), regional (lower extremity), and remote (upper extremity) anatomical sites. Results: We observed a significant main effect for time signifying reduced hypersensitivity (increased PPT) at local (p = .015) and regional (p = .014) locations at 3 weeks. Furthermore, there were significant main effects of time indicating improvements in pain (p &lt; .001) and disability (p = .02) from baseline among all participants regardless of intervention. However, no between-group differences were observed in PPT, clinical pain, or disability between the SMT and sham SMT groups over 3 weeks. Conclusions: After 3 weeks of SMT or sham SMT in CNSLBP patients, we found hypoalgesia at local and remote sites along with improved pain and low back-related disability.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • No
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • No
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • No
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

Both SMT and sham SMT had reduced hypersensitivity (increased PPT) at local and regional locations from pre-intervention to 3 weeks.

Key Finding #2

No immediate or 3-week hypoalgesia at a remote testing site—suggesting SMT may not have a widespread hypoalgesic effect on CNSLBP patients.

Key Finding #3

Regardless of intervention, there was an observed mean decrease in low back pain-related disability from baseline.

 

Please provide your summary of the paper

Following a 3-week course of SMT or sham SMT in CNSLBP patients, researchers found hypoalgesia at local and regional sites along with improved pain and low back- related disability. However, both groups (SMT and sham SMT) achieved similar outcomes in terms of PPT and clinical outcomes (NPRS and ODI). Therefore, this study suggests the method of SMT force application may not play a large influence on biological outcomes. However, the results should be interpreted with caution, as researchers acknowledge the sample does not accurately reflect the CNSLBP population. Furthermore, monitoring subjects over a longer period of time (i.e. 6 m/o) may help us discover if SMT produces long-term benefits for individuals experiencing CNSLBP.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The study suggests that within a short-term period (3 weeks), individuals with CNSLBP who receive SMT achieve the same results as those who do not receive it. Therefore, clinicians should conduct more research on the topic to determine if it is clinically necessary (and beneficial) for their respective patient populations. In the future, more longitudinal studies are required to develop hypotheses regarding the long-term effects of SMT for various patient populations.

Author Names

Peter O’Sullivan, Anne Smith, Darren Beales, Leon Straker

Reviewer Name

Madison Lapsley, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Synopsis Low back pain (LBP) is the leading cause of disability worldwide. It often begins in adolescence, setting a course for later in life. We have tracked the course of LBP in the Raine Study cohort from the age of 14 years into early adulthood. Our work has found that LBP is already prevalent in individuals at 14 years of age and increases throughout adolescence and into early adulthood. It is often comorbid with other musculoskeletal pain. For some adolescents, LBP has little impact; for others, its impact includes care seeking, taking medication, taking time off from school and work, as well as modifying physical and functional activity. Of concern is the increasing prevalence of LBP with impact across adolescence, reaching adult rates by 22 years of age. The predictors of disabling LBP in adolescence are multidimensional. They include female sex, negative back pain beliefs, poor mental health status, somatic complaints, involvement in sports, and altered stress responses. Genetics also plays a role. Ironically, the factors that we have historically thought to be important predictors of LBP, such as “poor” spinal posture, scoliosis, carrying school bags, joint hypermobility, and poor back muscle endurance, are not strong predictors. This challenges our clinical beliefs and highlights that adolescent LBP needs a flexible and targeted multidimensional approach to assessment and management. In most cases, we recommend a cognitive functional approach that challenges negative LBP beliefs, educates adolescents regarding factors associated with their LBP, restores functional capacity where it is impaired, and encourages healthy lifestyle habits.

NIH Risk of Bias Tool

Quality Assessment of Case-Control Studies

  1. Was the research question or objective in this paper clearly stated and appropriate?
  • Yes
  1. Was the study population clearly specified and defined?
  • Yes
  1. Did the authors include a sample size justification?
  • Yes
  1. Were controls selected or recruited from the same or similar population that gave rise to the cases (including the same timeframe)?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were the definitions, inclusion and exclusion criteria, algorithms or processes used to identify or select cases and controls valid, reliable, and implemented consistently across all study participants?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were the cases clearly defined and differentiated from controls?
  • Cannot Determine, Not Reported, Not Applicable
  1. If less than 100 percent of eligible cases and/or controls were selected for the study, were the cases and/or controls randomly selected from those eligible?
  • Cannot Determine, Not Reported, Not Applicable
  1. Was there use of concurrent controls?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were the investigators able to confirm that the exposure/risk occurred prior to the development of the condition or event that defined a participant as a case?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were the measures of exposure/risk clearly defined, valid, reliable, and implemented consistently (including the same time period) across all study participants?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were the assessors of exposure/risk blinded to the case or control status of participants?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were key potential confounding variables measured and adjusted statistically in the analyses? If matching was used, did the investigators account for matching during study analysis?
  • Cannot Determine, Not Reported, Not Applicable

Key Finding #1

“Interventions that reinforce positive back pain beliefs, functional restoration, and a healthy lifestyle hold promise to reduce the disability burden of this disorder.”

Key Finding #2

“A systematic review on physical therapy treatments for LBP in children and adolescents concluded that only 8 studies of limited quality had been conducted. Interventions in these trials consisted of education, exercise, or manual therapy, or a combination of the 3. Meta-analysis showed a positive effect for these interventions over control interventions, although the low number of studies and methodological limitations prevent definitive conclusions from being made.”

 

Please provide your summary of the paper

The overarching conclusion of this study was that a multidimensional approach consisting of the Cognitive Functional Approach alongside manual therapy techniques, exercise, education, etc for teens and adolescents with low back pain. Teens and adolescents are the most susceptible to back pain and issues due to environmental factors. The authors want to use the Cognitive Functional Approach to explore areas such as “Levels of disability and pain responses to functional activities, Avoidant coping behaviors, such as taking time off school or avoiding physical activity and activities of daily living, Back pain beliefs and fear of movement and activity, Levels of psychological and social distress, Lifestyle behaviors, such as sleep patterns and activity levels, Red flags, specific pathology, and comorbid health conditions.” The authors of this study recommend the use of multidimensional screening questionnaires to facilitate this process. This approach “combined with specific targeting of certain negative functional and lifestyle behavioral responses to low back pain” will hopefully reach the goal of the study. The hope is that with this approach, there is a shift in the perception of low back pain.

During this study, they found modifiable factors for the interview and examination components of the examination process. This includes 3 broad areas: Education, Functional Restoration, and Healthy Lifestyle. Under the Education component, using Reflective Questioning and Experimental Learning to “reinforce positive back pain beliefs” is the central component. For Functional Restoration, the overarching goal is to gradually engage in activities that usually cause pain by employing graduating conditioning and other techniques to build confidence. Lastly, a Healthy Lifestyle is always a good way to look at the health of the body globally. In this context, it will be used to build self-management strategies. The authors of this study want to modify these factors to provide multidimensional care to teens and adolescents with low back pain.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The use of this approach would only benefit teens and adolescents dealing with low back pain. It would allow clinicians to view all aspects of the patient’s life to effectively manage their care. I also believe that, as stated in the literature, a strong therapeutic approach is needed so that patients learn to move effectively and combat negative perceptions of low back pain. The authors want to use questionnaires to facilitate a Cognitive Functional Approach to low back pain. The implementation of the use of these questionnaires would require the least amount of effort on staff and be cost-effective for clinics.

Author Names

Behrangrad, S., Kamali, F.

Reviewer Name

Donald Lamotte, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Objective To compare the effectiveness of ischemic compression (IC) directly to the vastus medialis obliquus (VMO) versus lumbopelvic manipulation (LPM) in improving pain, functional status and sensitivity to mechanical stimulation of the VMO trigger point in patients with patellofemoral pain syndrome (PFPS).  Participants 40 patients with unilateral PFPS aged 20–30 years were selected randomly among patients with unilateral PFPS referred to physical therapy clinics of Shiraz University of Medical Sciences in Shiraz, Iran, between March 2014 and July 2014. 30 young adults participated. Participants were blinded to treatment allocation, and 15 patients were allocated to either IC or LPM.  Interventions Patients in both groups were treated in three sessions per week. IC consisted of three sets of continuous pressure applied for on the myofascial trigger point (MTrP) of VMO. LPM consisted of supine rotational glide manipulation of the ipsilateral lumbopelvic region of the involved knee.  Main outcome measures Numeric pain rating scale (VAS) for pain intensity, Kujala questionnaire for functional status, and pressure pain threshold (PPT) for sensitivity to mechanical stimulation. All three were recorded before treatment, 1 week, 1 month and 3 months after the last session.  Results Both groups showed significant improvement (p 0.05, 95% confidence interval) in pain, functional status and PPT values. However, the IC group showed greater improvements, and outcome measures remained significantly better than in the LPM group during post-intervention follow-up.  Conclusions Both groups showed improvements throughout the study and follow-up period. However, the IC showed better short-term and long-term effectiveness than LPM for treating PFPS.

NIH Risk of Bias Tool

Quality Assessment of Case-Control Studies

  1. Was the research question or objective in this paper clearly stated and appropriate?
  • Yes
  1. Was the study population clearly specified and defined?
  • Yes
  1. Did the authors include a sample size justification?
  • No
  1. Were controls selected or recruited from the same or similar population that gave rise to the cases (including the same timeframe)?
  • Yes
  1. Were the definitions, inclusion and exclusion criteria, algorithms or processes used to identify or select cases and controls valid, reliable, and implemented consistently across all study participants?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were the cases clearly defined and differentiated from controls?
  • Yes
  1. If less than 100 percent of eligible cases and/or controls were selected for the study, were the cases and/or controls randomly selected from those eligible?
  • No
  1. Was there use of concurrent controls?
  • Yes
  1. Were the investigators able to confirm that the exposure/risk occurred prior to the development of the condition or event that defined a participant as a case?
  • Yes
  1. Were the measures of exposure/risk clearly defined, valid, reliable, and implemented consistently (including the same time period) across all study participants?
  • No
  1. Were the assessors of exposure/risk blinded to the case or control status of participants?
  • Cannot Determine, Not Reported, Not Applicable
  1. Were key potential confounding variables measured and adjusted statistically in the analyses? If matching was used, did the investigators account for matching during study analysis?
  • No

 

Key Finding #1

Ischemic compression (IC) may be more beneficial than lumbopelvic manipulation (LPM) to improve pain, functional status, and pressure sensitivity in populations with PFPS

Key Finding #2

Patients with PFPS who received greater benefit from IC compared to LPM also had myofascial trigger points in the vastus medialis obliquus and SIJ dysfunction.

Key Finding #3

The studies usefulness is limited as they failed to treat other contributing factors to knee pain in patients and had a relatively small sample size.

 

Please provide your summary of the paper

This study aimed to compare the effectiveness of ischemic compression (IC) versus lumbopelvic manipulation (LPM) in the treatment of patellofemoral pain syndrome (PFPS) in 40 young adults. Participants were randomly selected from those referred to physical therapy clinics. The individuals underwent three sessions per week for both interventions, with outcomes measured using pain intensity  with the visual acuity scale (VAS) functional status (Kujala questionnaire), and sensitivity to mechanical stimulation (pressure pain threshold). Both groups showed significant improvements, but the IC group demonstrated greater short-term and long-term effectiveness than the LPM group, maintaining significantly better outcomes during post-intervention follow-up. The study revealed the presence of myofascial trigger points (MTrP) in the VMO of the symptomatic knee in all participants, emphasizing the importance of considering MTrP in understanding and treating PFPS. Overall, the findings suggest that ischemic compression targeting specific trigger points in the VMO may be a more effective therapeutic approach for PFPS compared to lumbopelvic manipulation.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The results from this study suggest that ischemic compression, targeting specific trigger points in the vastus medialis obliquus, may offer superior outcomes compared to lumbopelvic manipulation in the treatment of patellofemoral pain syndrome. That is not to say the use of LPM in clinic is ineffective as both groups had significant improvements. This may enhance patient outcomes in practice and help with tailoring interventions for the individual.

Author Names

Espí-López, G.V., Ruescas-Nicolau, M., Castellet-García, M., Suso-Martí, L., Cuenca-Martínez, F., Marques-Sule, E.

Reviewer Name

Gabryella Lakes, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Self-massage using foam rolling (FR) has been posited to have similar benefits as those traditionally associated with manual therapy (MT) but more economical, easy, and efficient. Despite the widespread use of this technique for the recovery of athletes, there is no evidence supporting the effectiveness of FR vs. MT. The purpose of this study was to assess the effects of FR self-massage in athletes after a high-intensity exercise session compared with a MT protocol. A randomized controlled trial was performed. Forty-seven volunteer amateur athletes (22.2 ± 2.5 years, 53.2% men) were divided into 3 groups: a FR group ( n = 18, performed FR self-massage), a MT group ( n = 15, received a MT protocol), and a control group ( n = 14, passive recovery). After an intense exercise session, dynamic balance, lumbar and hip flexibility, and leg dynamic force were assessed before and after the intervention and 1 week later. Results showed that, in the FR group, dynamic balance scores increased for both limbs at postintervention ( p = 0.001) and at follow-up ( p = 0.001). These scores were higher for the FR group vs. the MT group at postintervention (right limb, p = 0.048) and at follow-up (right limb: p = 0.049; left limb: p = 0.048), although this variable differed at baseline. In all the groups, lumbar flexion increased at postintervention ( p &lt; 0.05), although it was only maintained in the FR group at follow-up ( p = 0.048). In conclusion, self-massage with FR may be more effective than MT for the recovery of dynamic balance in athletes after intense exercise, although this result should be interpreted with caution. Foam rolling could have a relevant role in postexercise recovery to prevent injuries in athletes.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

The Foam Rolling Technique (FRT) is comparable to a Manual Therapy (MT) protocol in significant overall effectiveness, with FRT showing a tendency to produce greater immediate benefits on dynamic balance.

Key Finding #2

Both the Foam Rolling Technique (FRT) and Manual Therapy (MT) significantly improved lumbar spine flexibility immediately post-intervention, but need further research regarding the effect over time.

Key Finding #3

The intervention protocol used in this study neither impaired nor improved jump performance, but perception of change was significantly greater compared to the control group, indicating a possible indirect effect on athletic performance by significantly affecting lumbar flexibility and dynamic balance, and helping to relieve muscle fatigue.

 

Please provide your summary of the paper

This study aimed to compare the effect of foam rolling versus manual therapy on several factors of athletic performance, following a high-intensity workout session, including dynamic balance, flexibility, and dynamic force. As foam rolling and manual therapy have been compared as having similar benefits, the results of this study presented a more economic, easy, and efficient recovery technique that still targeted combating muscle fatigue and decreasing myalgia in athletes, post-exercise. The effects of these techniques were only analyzed in short-term periods (1 week post initial session); therefore, the overall long-term effects and benefits of these techniques, as compared to one another, have not been determined at this time. Overall, it was found that both foam rolling and manual therapy improved dynamic balance after the intervention; however, there was greater immediate improvement seen in the foam rolling group. It was also found that both foam rolling and manual therapy had immediate and significant effects on improvement in lumbar flexibility, but no effect on leg dynamic force and hip flexibility. Due to these conclusions, it is suggested that foam rolling is as effective as manual therapy in treating post-activity recovery, and that it would be a viable treatment alternative for therapists and trainers to utilize in the athletic population.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This randomized control trial offers clinicians a therapeutic post-exercise intervention that is not only comparable to manual therapy, but also can be recommended to athletes to be used when manual therapy is not available. Balance impairments and muscle flexibility are specifically two factors that can contribute to post-exercise injuries, both of which this study found are significantly impacted by foam rolling. In this regard, the results suggest that foam rolling can be clinically useful as an immediate treatment option in the recovery of dynamic balance and flexibility in athletes. There is currently no long-term evidence of one method being more beneficial than the other since this study only focuses on short-term benefits of foam rolling versus manual therapy. As the target population of this study was amateur athletes, evidence for utilization and effectiveness of foam rolling as compared to manual therapy in the general population has not been determined at this time, which should be considered when using this study as potential evidence/clinical reasoning. Since this is the first study comparing foam rolling to manual therapy, there are still many factors that were not taken into consideration – i.e., muscle fatigue – resulting in the need for continued RCTs to provide additional findings.

Author Names

Oguz Dayanir, I., Birinci, T., Kaya Mutlu, E., Ali Akcetin, M., & Osman Akdemir, A.

Reviewer Name

Madeline Koontz, SPT

Reviewer Affiliation(s)

Duke Doctor of Physical Therapy Division

Paper Abstract

Objectives: This pilot study aimed to compare the efficacy of manual pressure release (MPR), strain counterstrain (SCS), and integrated neuromuscular inhibition technique (INIT) in the management of chronic nonspecific low back pain (LBP).  Design: Single-blind, randomized, controlled pilot trial.  Setting: Neurosurgery clinic.  Subjects: Forty-eight patients (46 women; mean age, 35.47 ± 10.58 years) diagnosed chronic nonspecific LBP and who had at least one active myofascial trigger point (MTrP) in the quadratus lumborum, iliocostalis lumborum, gluteus maximus, gluteus medius, and gluteus minimus muscles were included.  Interventions: Patients received a standard home exercise program in addition to the MPR technique (MPR group), SCS technique (SCS group), and INIT (INIT group) for 12 sessions (2 days/week for 6 weeks).  Outcome measures: The primary outcome was the visual analog scale (VAS). The secondary outcomes were MTrP examination, pressure pain threshold, lumbar active range of motion, Oswestry Disability Index (ODI), Beck depression inventory, and state-trait anxiety inventory.  Results: There is no significant difference in terms of the percentage of deactivated MTrPs after 1st session and 12th session between groups (p &gt; 0.05), but the percentage of deactivated MTrPs was less in MPR group than other groups. The overall group-by-time interaction for the repeated measures analysis of variance was not significant for primary and secondary outcomes (p &gt; 0.05), but the improvement in the VAS-activity and the ODI was slightly better in the SCS group compared with other groups.  Conclusions: These preliminary findings, which might help provide a glimpse into the clinical effectiveness of three manual therapy techniques (MPR, SCS, and INIT) rather than statistical significance, indicated that SCS or INIT might provide slightly better improvement in pain during activity, deactivation of MTrPs, and disability related to pain in chronic nonspecific LBP.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • No
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

Key Finding #1

After a six-week intervention, similar improvements in active range of motion, depression, anxiety, pain-related disability, pain intensity, and pressure pain threshold were found between the three groups. Therefore, no single manual therapy technique stands out in this regard.

Key Finding #2

Improvement on the visual analog scale during activity was greater in the SCS group than the other two groups. Although no significant difference between the three techniques in other areas, the SCS technique may reduce pain with movement more than the MPR and INIT techniques.

Key Finding #3

More trigger points were deactivated in the groups receiving SCS and INIT techniques than in the group receiving the MPR technique, which may lead to less pain later on.

 

Please provide your summary of the paper

This study compares the effects of three different manual therapy techniques combined with a home exercise program on chronic pain levels. It found similar beneficial results in all three treatment groups. However, reduction in pain during activity was greatest in the group receiving SCS.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

While many other studies compare manual therapy as a whole to other treatments, this study stands out as it aims to determine the most effective manual therapy technique on pain reduction. This information is important for clinicians to know, as these techniques are powerful tools when used appropriately. If a patient is experiencing frequent pain with activity, the clinician may consider using the SCS technique. This study contains limitations. It did not include a group that participated in a home exercise program without any manual therapy treatment, which would have been useful to see as a comparison to the three manual therapy technique groups. The relatively small sample size of 46 participants is a limitation in broadly applying the results of this study. Additionally, it would be beneficial to see a gender comparison in the future, as this study used only female participants.

Author Names

Byungho K, Taeyeong K, Junghoon A, Heecheol C, Dongyun K, Bumchul Y

Reviewer Name

Madison Keller, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: Studies have shown late post-operative physical disability and residual pain in patients following lumbar disc surgery despite growing evidence of its beneficial effects. Therefore, rehabilitation is required to minimise the late post-operative complications.  Objective: To assess the feasibility of manipulative rehabilitation to improve late post-operative outcomes.  Methods: Twenty-one patients aged 25-65 years undergoing lumbar microdiscectomy were randomly assigned to the rehabilitation group (n= 14) or active control group (n= 7) by simple randomisation. Eight rehabilitation sessions were initiated 2-3 weeks after surgery. Thirty-minute sessions were conducted twice weekly for four weeks. Post-operative physical disability and pain were assessed at baseline and at the two-year follow-up.  Results: Post-operative physical disability improved more in patients who had undergone rehabilitation than in those who had received control care (63% vs. -23%, P&lt; 0.05). Post-operative residual low back and leg pain were alleviated in the treatment group (26% and 57%, respectively), but intensified in the control group (-5% and -8%, respectively).  Conclusions: This study demonstrated the potential of manipulative rehabilitation and importance of post-operative management after lumbar disc surgery. Definitive trials with larger sample sizes are required to confirm the feasibility and potential therapeutic effectiveness of this approach.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • No
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

Two years post lumbar microdiscectomy, there was a 63% improvement in post-operative physical disability in participants in the osteopathic manipulative treatment (OMT) group, measured with the Roland-Morris Disability questionnaire (RDQ), compared to participants in the active control group which saw a reduction of 23% from their baseline score.

Key Finding #2

The OMT group demonstrated a significant decrease of 26% in low back pain, evaluated with a visual analogue scale (VAS), compared to participants in the active control group which saw a 5% increase in pain.

Key Finding #3

The OMT group demonstrated a 57% decrease in leg pain, evaluated with a VAS, compared to participants in the active control group which saw an 8% increase in pain.

 

Please provide your summary of the paper

This article evaluated the effect of manipulative therapy on outcomes of late-stage, two-years post-operative, post-lumbar microdiscectomy patients. Participants were randomized into two groups, the osteopathic manipulative treatment (OMT) group and the active control group. Techniques included in the biweekly OMT rehabilitation protocol included myofascial release techniques, osteopathic soft-tissue techniques, osteopathic joint mobilization techniques, counter-strain techniques, neuromuscular techniques, and muscle energy techniques. The active control group included verbal education on a home exercise program and prescription medications for pain and inflammation. The results of this study demonstrate significant improvements in outcomes including low back pain, leg pain, and disability in the OMT group compared to the active control group. However, this study has several limitations. Some of these limitations include lack of blinding of participants and researchers to the groups, lack of placebo group, and a small sample size of 21 participants. Based on the results of this study, there is evidence that OMT is effective in improving patient’s self-reported outcomes in late stage post-operative participants.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This study demonstrates the effectiveness of osteopathic manipulative therapy on patients post lumbar disc surgery. However, there are many study limitations to consider when applying this research to clinical practice. Due to the small sample size, the results of this study should be further evaluated with a larger sample size for more generalizable clinical implications. Furthermore, replicating the methods of this study could prove difficult due to the fact that intensity and sequence of treatment techniques were individualized to each participant. It is important to have an individualized, patient-centered approach to treatment, and although the dosing of the treatment was not specified, there was an overall improvement in patient reported outcome measures with the OMT group, showing the effectiveness of this treatment on pain and disability scores.

Author Names

Thomas, J., Clark, B., Russ, D., France, C., Ploutz-Snyder, R., Corcos, D.

Reviewer Name

Julianna Hom, SPT

Reviewer Affiliation(s)

Duke University DPT

Paper Abstract

Importance  Low back pain (LBP) is one of the most common reasons for seeking medical care. Manual therapy is a common treatment of LBP, yet few studies have directly compared the effectiveness of thrust (spinal manipulation) vs nonthrust (spinal mobilization) techniques.  Objective  To evaluate the comparative effectiveness of spinal manipulation and spinal mobilization at reducing pain and disability compared with a placebo control group (sham cold laser) in a cohort of young adults with chronic LBP.  Design, Setting, and Participants  This single-blinded (investigator-blinded), placebo-controlled randomized clinical trial with 3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017. Of 4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups. Recruitment began on June 1, 2013, and the primary completion date was August 31, 2017. Data were analyzed from September 1, 2017, to January 20, 2020.  Interventions  Participants received 6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo) during a 3-week period. Main Outcomes and Measures Coprimary outcome measures were the change from baseline in Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range from 0 to 24, with higher scores indicating greater disability) 48 to 72 hours after completion of the 6 treatments.  Results  A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain) were randomized. Fifty-four participants were randomized to the spinal manipulation group, 54 to the spinal mobilization group, and 54 to the placebo group. There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability. At the primary end point, there was no significant difference in change in pain scores between spinal manipulation and spinal mobilization (0.24 [95% CI, −0.38 to 0.86]; P = .45), spinal manipulation and placebo (−0.03 [95% CI, −0.65 to 0.59]; P = .92), or spinal mobilization and placebo (−0.26 [95% CI, −0.38 to 0.85]; P = .39). There was no significant difference in change in self-reported disability scores between spinal manipulation and spinal mobilization (−1.00 [95% CI, −2.27 to 0.36]; P = .14), spinal manipulation and placebo (−0.07 [95% CI, −1.43 to 1.29]; P = .92) or spinal mobilization and placebo (0.93 [95% CI, −0.41 to 2.29]; P = .17).  Conclusions and Relevance  In this randomized clinical trial, neither spinal manipulation nor spinal mobilization appeared to be effective treatments for mild to moderate chronic LBP.  Trial Registration  ClinicalTrials.gov Identifier: NCT01854892

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • No
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • No
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

There is no difference in change in pain scores when comparing the effects of spinal manipulation, spinal mobilization, and a placebo treatment.

Key Finding #2

There is no difference in self-reported disability scores when comparing the effects of spinal manipulation, spinal mobilization, and a placebo treatment.

Key Finding #3

Sex has no impact on pain scores or self-reported disability scores following spinal manipulation, spinal mobilization, or a placebo treatment.

 

Please provide your summary of the paper

This study featured 162 participants who were randomly assigned to three groups: spinal manipulation, spinal mobilization, or sham cold laser therapy. The latter treatment acted as a placebo treatment. The investigators were blinded to the participants’ group assignments. The participants were selected based on defined inclusion criteria determined by the investigators, but all were young adults with a history of mild to moderate chronic low back pain. The participants received six treatment sessions over the course of three weeks. The spinal manipulation and mobilization groups each received one type of manual therapy technique. The participants’ results were analyzed via the Numerical Pain Rating Scale (NPRS) and the Roland-Morris Disability Questionnaire. The results concluded that there were no significant differences in NPRS and Roland-Morris Disability Questionnaire scores between the three studied groups following the six treatment sessions.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The study determines that spinal manipulation and mobilization techniques have no impact on pain and disability scores when reviewed against a placebo treatment. However, the study only featured one type of spinal manipulation and one type of spinal mobilization. It would have been useful to see other types of manipulations or mobilizations performed to see if one would have a more significant effect on this population. Additionally, clinicians were only allowed two attempts at each manipulation and the presence of cavitations determined if a second attempt would be allowed. However, the article lacks discussion on the reliability of cavitations as an indicator for considering treatment to be “complete.” Furthermore, the article suggests that spinal manipulation and mobilization techniques may be effective in young adults with acute or subacute low back pain or in patients with more severe pain levels. It would be helpful to see the effects of manual therapy within these populations to determine if spinal mobilizations and manipulations are overall indicated in the treatment of low back pain. This study suggests that spinal mobilizations and manipulations may not be effective treatments within this population, but does not offer alternative treatments to implement into clinical practice.