Lumbopelvic

Author Names

Sean Hanrahan; Bonnie L. Van Lunen; Michael Tamburello; Martha L. Walker

Reviewer Name

Jessica Fritson, SPT, ATC

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Context: Although a variety of theories and studies have been cited to support the use of joint mobilization in the spine as an integral part of the treatment and rehabilitation process, information about the short-term effects of joint mobilization on acute low back injury with respect to patient pain and strength changes has been limited.   Objective: To examine the short-term effects of grade 1 and 2 posteroanterior joint mobilizations at the lumbar spine on subject pain and muscle force after an episode of acute, mechanical low back pain.  Design: Group (2) by time (2 or 3).
 Setting: Athletic training clinic. Patients or Other  Participants: Male collegiate athletes (n = 19) with mechanical low back pain as assessed through a standardized evaluation were randomly assigned to a control (n = 10) or experimental (n = 9) group.   Intervention(s): All subjects underwent a standardized treatment protocol of cryotherapy and stretching during data collection. Subjects completed the McGill Pain Questionnaire and a visual analog scale (the latter to assess pain levels during range-of-motion activities) and, using a handheld dynamometer, performed 3 maximum voluntary isometric contractions to determine muscle force. Grade 1 and 2 joint mobilizations were administered to the experimental group, whereas the control group was placed in a prone position of comfort for the time it took to perform the joint mobilizations.   Main Outcome Measure(s): Baseline, immediate post-treatment, and 24-hour post-treatment measurements of pain and muscle force were taken.  Results: Compared with the control group, the experimental group demonstrated significant decreases in the sensory sub-scale scores of the McGill Pain Questionnaire and in pain during lumbar extension and a significant increase in force production.   Conclusions: Grade 1 and 2 joint mobilizations reduced subjects’ pain and increased force production in the short-term stages of mechanical low back pain.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT

• Yes

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

• Cannot Determine, Not Reported, or Not Applicable

Was the treatment allocation concealed (so that assignments could not be predicted)?

• No

Were study participants and providers blinded to treatment group assignment?

• No

Were the people assessing the outcomes blinded to the participants’ group assignments?

• No

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

• Yes

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

• Yes

Was there high adherence to the intervention protocols for each treatment group?

• Yes

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

• Yes

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

• Yes

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

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• Yes

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 was no significant difference in the McGill Pain Questionnaire between the group of athletes who received joint mobilization treatment for mechanical low back pain and those who did not.

Key Finding #2

There was an increase in paraspinal activation for athletes who received joint mobilization intervention in immediate and 24-hour post-testing.

Key Finding #3

Joint mobilization for the lumbar spine in athletes is beneficial for decreasing mechanical low back pain over time during end range flexion and extension.

Key Finding #4

Grade 1 and 2 joint mobilizations for athletes with minor mechanical low back pain injuries aided in the short-term rehabilitation process requiring little time and no cost.

Please provide your summary of the paper

The random control trial in this article consisted of 19 NCAA Division III male athletes with an average age of 20.3 years old. They all report with acute low back pain which started less than 49 hours prior to the experiment and were excluded if they were suspected to have any condition that was not mechanical in nature where joint manipulation was contraindicated. The McGill Pain Questionnaire, dynamometer paraspinal force production, and the visual analog scale during lumber flexion and extension were measures utilized within the study. Participants were tested prior to, immediately after, and 24-hours after treatment to assess the effects of joint mobilization as treatment compared to the control group who only received the standard protocol for all participants consisting of 15 minutes of cryotherapy and a stretching routine of for the hamstrings, hip rotators, and low back. The experimental group received Grade I and II posteroanterior joint mobilizations in prone position for 6 sets of 30 seconds to the 3 spinous processes around the level of pain. Key findings to the study are stated above.

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

Grades 1 and 2 mobilizations can be a beneficial tool used to treat athletes with minor, acute mechanical low back pain when there are no contraindications present. It is important for the physical therapist to perform a thorough examination to rule out radicular involvement, disc involvement, fracture, and potential other causes of pain that were not included in the study. Though there was a decrease in pain in both groups, other areas looked at in the study such as paraspinal activation and pain during end ranges of flexion and extension supported the use of posteroanterior joint mobilizations for this patient population. Looking at clinical practice of low back pain in athletics, joint mobilization could be a good tool to use in certain situations of acute mechanical low back pain as it does not take much time or cost. Using a test-retest method to assess success of joint mobilization treatment can assess whether this treatment is helping decrease pain or increase motion for patients. This study is limited to the short-term (24-hour) effects of joint mobilization treatment, Grade I and II mobilizations, and only specific to 20-year-old male athletes with acute low back pain. It is important to consider all aspects of the patient and skills of the physical therapist when implementing joint mobilizations as treatment.

Author Names

Pierre B.

Reviewer Name

Miranda Frohlich, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest that manual therapy (MT) induces an immediate analgesic effect through neurophysiologic mechanisms at peripheral, spinal and cortical levels. The aim of this pilot study was first, to assess whether MT has an immediate analgesic effect, and second, to compare the lasting effect on functional disability of MT plus AE to sham therapy (ST) plus AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Immediate analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index), fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire), erector spinae and abdominal muscles endurance (Sorensen and Shirado tests) were assessed before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups. Results: Thirty-seven subjects completed the study. MT intervention induced a better immediate analgesic effect that was independent from the therapeutic session (VAS mean difference between interventions: -0.8; 95% CI: -1.2 to −0.3). Independently from time after treatment, MT + AE induced lower disability (ODI mean group difference: -7.1; 95% CI: -12.8 to −1.5) and a trend to lower pain (VAS mean group difference: -1.2; 95% CI: -2.4 to −0.30). Six months after treatment, Shirado test was better for the ST group (Shirado mean group difference: -61.6; 95% CI: -117.5 to −5.7). Insufficient evidence for group differences was found in remaining outcomes.

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)?

• Yes

4. Were study participants and providers blinded to treatment group assignment?

• Yes

5. Were the people assessing the outcomes blinded to the participants’ group assignments?

• Yes

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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?

• No

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?

• Yes

Key Finding #1

The immediate analgesic effect of intervention was in favor of manual therapy over detuned ultrasound.

Key Finding #2

Manual therapy combined with active exercise (specifically the MT techniques and exercise type, dosage, and progression used in the study) can be efficient to decrease pain for CNSLBP.

Key Finding #3

There was insufficient evidence for the effect of manual therapy + active exercise on FABQ-wk, FABQ-pa and Sorensen scores.

Key Finding #4

The results of this pilot study need to be further confirmed by future studies with appropriate sample sizes.

Please provide your summary of the paper

This study was performed to assess whether manual therapy (MT) has an immediate analgesic effect and to compare the effect of MT combined with active exercise (AE) to a control group on functional disability. The experimental group consisted of MT + AE. The control group consisted of sham therapy (ST) and AE. The ST intervention relied on detuned ultrasound – meaning the ultrasound was inactivated and ineffective. There were several methods used to compare changes in pain and function, including a visual analogue scale (VAS), Oswestry Disability Index (ODI), fear-avoidance beliefs (Fear-avoidance Beliefs Questionnaire), Sorenson (erector spinae), and Shirado (abdominal muscles endurance). These outcome measures are reliable and were assessed before each treatment, after the 8th therapeutic session, and at 3 and 6 month follow ups. To the author’s knowledge, this study is the first controlled study to assess the efficacy of spinal manipulation/mobilization followed by specific active exercises. The findings confirm the immediate analgesic effect of manual therapy (MT) for patients with CNSLBP. It can be strongly suggested from the results of this study that the analgesic effect of MT combined with AE can be productive in decreasing pain for patients with CNSLBP. Furthermore, it has been proposed that MT may allow the patient to perform more accurate active exercises and provide better facilitation of muscle activation.   There are limitations concerning the results (due to small sample size) and future testing with appropriate sample sizes are needed for confirmation of findings. There was insufficient evidence for the effect of MT + active exercise (AE) on FABQ-wk, FABQ-pa or Sorensen scores. Lastly, the process of finding patients was provided solely by the rheumatology clinic of a University hospital, which does not reflect the CNSLBP population as a whole.

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

To begin, I believe the study provided strong evidence for the clinical relevance of MT, itself, and MT combined with AE in the use of treatment for patients with CNSLBP. The organization and plan of treatments, and the specification of interventions for MT/ST and exercises, provides clinicians with the ability to replicate these techniques in clinical practice. In saying this, I think the study could have provided an even greater impact in clinical practice by knowing which MT intervention, out of the three MT intervention(s), correlated most with a decrease in pain for patients with CNSLBP.  Lastly, the findings of the study do need to be further assessed on a larger scale.

Author Names

Fernando de Oliveira, Ronaldo, Pena Costa, Leonardo, Nascimento, Leonardo, Rissato, Livia

Reviewer Name

Erik Furseth SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Question: In people with chronic low back pain, what is the average effect of directing manipulation at the most painful lumbar level compared with generic manipulation of the spine? Design: Randomised controlled trial with concealed allocation, a blinded assessor and intention-to-treat analysis. Participants: 148 people with non-specific chronic low back pain with a minimum level of pain intensity of 3 points (measured from 0 to 10 on the Pain Numerical Rating Scale). Interventions: All participants received 10 spinal manipulation sessions over a 4-week period. The experimental group received treatment to the most painful segment of the lower back. The control group received treatment to the thoracic spine. Outcome measures: The primary outcome was pain intensity, measured at the end of the intervention (Week 4). Secondary outcomes were: pain intensity at Weeks 12 and 26; pressure pain threshold at Week 4; and global perceived change since onset and disability, both measured at Weeks 4, 12 and 26. Results: Each group was randomly allocated 74 participants. Data were collected at all time points for 71 participants (96%) in the experimental group and 72 (97%) in the control group. There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point. The estimate of the effect of directing manipulation at the most painful lumbar level, as compared with generic manipulation, on pain intensity was too small to be considered clinically important: MD 0 (95% CI 20.9 to 0.9) at Week 4 and 20.1 (95% CI 21.0 to 0.8) at Week 26. Conclusion: No clinically important differences were observed between directed manipulation and generic manipulation in people with chronic low back pain.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT

• Yes

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

• Yes

Was the treatment allocation concealed (so that assignments could not be predicted)?

• Yes

Were study participants and providers blinded to treatment group assignment?

• No

Were the people assessing the outcomes blinded to the participants’ group assignments?

• Yes

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

• Cannot Determine, Not Reported, or Not Applicable

Was there high adherence to the intervention protocols for each treatment group?

• Yes

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

• No

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

• Yes

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

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• Yes

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

Were the included studies listed along with important characteristics and results of each study?

• Yes

Key Finding #1

The use of spinal manipulation is effective at reducing pain intensity in those with lumbar back pain.

Key Finding #2

There appears to be no difference in pain modulation difference between a patient receiving a thoracic spinal manipulation or a lumbar spinal manipulation in patients with chronic low back pain.

Please provide your summary of the paper

In this study, the researchers sought to determine if a general vertebral manipulation had the same effect on patient low back pain as a directed manipulation to the specific segment that is feeling pain. Using 148 participants, the researchers assigned 74 of them into 2 groups, an experimental group and a controlled group. The control group received a spinal manipulation to the thoracic spine and the experimental group received the spinal manipulation to the joint that hurt the most. Both groups experienced pain relief after 10 sessions over the course of 4 weeks.

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

Based on these findings, it seems that it could be more of a placebo effect when getting joint manipulations. If the patient feels like they are getting something, they may feel like they are getting better. It could also be that increasing mobility at a more distal joint could aid in increasing range of motion of the spine as a whole. Since each segment has limited movement, an issue with one joint could cause limitations further up the chain. What makes this study important is it shows that there may not be a great need to learn multiple spinal manipulations for different patients. If a patient is too irritated to perform a spinal manipulation to their lumbar region, it would be just as beneficial to perform a thoracic manipulation to help relieve their pain. This would also be true for patients that may not be mobile enough to get into a certain position or have injuries/body issues that might not let them lie or twist a specific way.

Author Names

Nowall A. Al-Sayegh, PhD, Susan E. George, DPT, Michael L. Boninger, MD, Joan C. Rogers, PhD, Susan L. Whitney, PhD, Anthony Delitto, PhD*

Reviewer Name

Kayla Grace, SPT, B.S Exercise Physiology

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective: To develop a clinical prediction rule (CPR) for identifying postpartum women with low back pain (LBP) and/or pelvic girdle pain (PGP) whose functional disability scores improve with a high-velocity thrust technique (HVTT) conducted by a physical therapist.

Design: Prospective cohort.

Setting: Outpatient physical therapy departments.

Participants: Sixty-nine postpartum women referred to physical therapy with the complaint of LBP and/or PGP.

Methods: Subjects underwent a physical examination and a HVTT to the lumbopelvic region. Main Outcome Measures: Success with treatment was determined by the use of percent changes in disability scores and served as the reference standard for determining accuracy of the examination variables. Variables with univariate prediction of success and nonsuccess were combined into multivariate CPRs.

Results: Fifty-five subjects (80%) had success with the HVTT. A CPR for success with 4 criteria was identified. The presence of 2 of 4 criteria (positive likelihood ratio ? 3.05) increased the probability of success from 80% to 92%. A CPR for treatment failure with 3 criteria was identified. The presence of 2 of 3 criteria (positive likelihood ratio ? 11.79) increased the probability of treatment failure from 20% to 75%.

Conclusions: The pretest probability of success (80%) is sufficient to reassure the clinician about the decision to use a HVTT to the lumbopelvic region in postpartum women with LBP and/or PGP. If 2 of 3 criteria for treatment failure are met in the CPR, an alternative approach is warranted. An intervention such as the HVTT is compelling, given the need to minimize pharmaceutical remedies in women who are potentially breast-feeding postpartum.

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

2. Were eligibility/selection criteria for the study population prespecified and clearly described?

• Yes

3. 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

4. Were all eligible participants that met the prespecified entry criteria enrolled?

• No

5. Was the sample size sufficiently large to provide confidence in the findings?

• Yes

6. Was the test/service/intervention clearly described and delivered consistently across the study population?

• Yes

7. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?

• Yes

8. Were the people assessing the outcomes blinded to the participants’ exposures/interventions?

• Cannot Determine, Not Reported, Not Applicable

9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis?

• Yes

10. 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

11. 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

12. 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

Among the patient history and self-report variables, the use of oral contraceptives was most predictive of success, whereas among the physical examination variables, symmetrical posterior superior iliac spine (PSIS) test in the seated position was most predictive of success.

Key Finding #2

Among the patient history and self-report variables, age was most predictive of nonresponse to the intervention, whereas among the physical examination variables, a positive PSIS symmetry test in the seated position and a positive SIJ stiffness test were most predictive of nonresponse.

Key Finding #3

The CPR for women who responded less favorably to the HVTT consisted of 3 variables: age 35 years (women older than 35 less likely to respond to HVTT), VASBest score 3, and a negative prone knee bend test.

Please provide your summary of the paper

This study follows 69 postpartum individuals who indicate LBP and/or PGP.  Each participant at baseline completes an ODQ form to measure a reference standard to be compared to following HVTT (high-velocity thrust techniques) intervention in order to develop a clinical prediction rule to identify patients most likely to benefit from HVTT intervention. An initial ODQ had to be at least 30% to participate, and patients were required to complete multiple validated self-reported measures related to their pain.  Qualified patients then received HVTT to their most symptomatic side in the form of passively being side bent toward their painful side, rotated trunk in the direction opposite the side bent side, and a PT delivered grade V thrust in a posterior and inferior direction. 2 attempts were permitted if an audible pop was not heard following the first thrust (a pop is not indicative of successful intervention performance). Pts were then asked to perform 10 reps of a hand-heel rock range of motion exercise and to follow up 2-4 days later to complete a subsequent ODQ form.  Following the study, clinicians emphasized the importance of greater PT exposure by other disciplines to promote awareness of the role PT can have in treating LBP and PGP.  A clinical prediction rule was successfully created, however, in order to validate the rule, a randomized clinical trial will now need to be implemented.

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

Following this paper, it would be beneficial to complete a randomized clinical trial to validate the CPR stated.  It would also be helpful to further investigate LBP and PGP in postpartum individuals separate from the general population to provide better, individualized care to this pt population.  Being able to narrow down clinical presentation and pinpoint trends will allow clinicians to better implement hypothetico-deductive reasoning.  Emphasizing early PT intervention for this pt population will allow the opportunity for better outcomes, and the use of manual therapy to be potentially implemented as standardized care during and following pregnancy to mitigate LBP and PGP.

Author Names

Ulger, O

Reviewer Name

Laurel Hale, Duke SPT ‘24

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

BACKGROUND AND OBJECTIVES: To determine the effects of spinal stabilization exercises (SSE) and manual therapy methods on pain, function and quality of life (QoL) levels in individuals with chronic low back pain (CLBP). METHODS: A total of one-hundred thirteen patients diagnosed as CLBP were enrolled to the study.The patients allocated into Spinal Stabilization group (SG) and manual therapy group (MG), randomly. While SSE performed in SG, soft tissue mobilizations, muscle-energy techniques, joint mobilizations and manipulations were performed in MG. While the severity of pain was assessed with Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and Short Form 36 (SF-36) assessments were performed to evaluate the functional status and QoL, respectively. All assessments were repeated before and after the treatment.  Results: Intragroup analyses both treatments were effective in terms of sub parameters of pain, function and life quality (p < 0.05). Inter group analyses, there was more reduction in pain and improvement in functional status in favor of MG (p <0.05). CONCLUSIONS: This study showed that SSE and manual therapy methods have the same effects on QoL, while the manual treatment is more effective on the pain and functional parameters in particular.   Keywords: Low back pain, pain, rehabilitation, exercise, quality of life

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)?

• Yes

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?

• Yes

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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?

• Yes

13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• No

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?

• Yes

Key Finding #1

Exercise and manual therapy can decrease pain and improve function in patients with CLBP (chronic low back pain).

Key Finding #2

Manual therapy group produced more significant improvements in severity of pain, functional improvements, and disability measures (e.g: ODI) over exercise group.

Please provide your summary of the paper

While this study found that exercise and manual therapy both decrease pain, disability, and quality of life in similar ways, manual therapy was found to be more effective in reducing pain and measures of disability.

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

While reading the interventions for the exercise group, I feel that the exercises could have been advanced further in the later weeks to make them more functional for ADLs (activities of daily living) but I thought they started off at an appropriate level for patients with CLBP (chronic low back pain), who could get easily irritated in early weeks of the study. It would be interesting to see further research comparing exercise AND manual therapy to manual therapy alone to exercise alone in a similar demographic population of patients with CLBP.

Author Names

Paige NM, Miake-Lye IM, Booth MS, Beroes JM, Mardian AS, Dougherty P, Branson R, Tang B, Morton SC, Shekelle PG

Reviewer Name

Kimberlyn Hayes, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Importance  Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT.  Objective  To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain.  Data Sources  Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms.  Data Extraction and Synthesis  Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.  Main Outcomes and Measures  Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.  Findings  Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.  Conclusions and Relevance  Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

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

2. Were eligibility criteria for included and excluded studies predefined and specified?

• Yes

3. Did the literature search strategy use a comprehensive, systematic approach?

• Yes

4. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• Yes

5. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• Yes

6. Were the included studies listed along with important characteristics and results of each study?

• Yes

7. Was publication bias assessed?

• Yes

8. Was heterogeneity assessed? (This question applies only to meta-analyses.)

• Yes

Key Finding #1

Spinal manipulative therapy (SMT) treatments for patient with acute low back pain was associated with a modest improvement in pain and function at up to 6 weeks.

Key Finding #2

There was minimal harm to the musculoskeletal system that lasted for a short period of time following SMT treatments in patients with acute low back pain.

Please provide your summary of the paper

This systematic review and meta-analysis found that spinal manipulative therapy (SMT) treatments were associated with modest improvement in pain and function in patients with acute low back pain. Additionally, there was minimal musculoskeletal harm that only lasted for a short period of time. One notable study limitation was the large heterogeneity in treatment effects which may be an area for further research. While this article has a low risk for bias, it must also be noted that of the studies that were reviewed, more of them were classified as low quality than high quality. Nonetheless, SMT appears to be a safe and effective treatment for this patient population.

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

Clinically, it may be beneficial to implement spinal manipulative therapy techniques with patients that have acute low back pain. The potential benefits appear to outweigh the potential harms. However, with only a modest improvement in pain and function, it may be beneficial to use a multimodal approach when considering treatments.

Author Names

Zafereo, J., Wang-Price, S., Roddey, T., & Brizzolara, K.

Reviewer Name

Jada Holmes, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objectives: Clinical practice guidelines recommend a focus on regional interdependence for the management of chronic low back pain (CLBP). This study investigated the additive effect of regional manual therapy (RMT) when combined with standard physical therapy (SPT) in a subgroup with CLBP. Methods:  Forty-six participants with CLBP and movement coordination impairments were randomly assigned to receive SPT consisting of a motor control exercise program and lumbar spine manual therapy, or SPT with the addition of RMT to the hips, pelvis, and thoracic spine. Outcome measures included disability level, pain intensity, pain catastrophizing, fear avoidance beliefs, and perceived effect of treatment. Appropriate parametric and non-parametric testing was used for analysis. Results:  Both groups demonstrated improvements in disability level, pain intensity, pain catastrophizing, and fear avoidance beliefs across time (P < .001). There was no difference between groups for any variable over 12 weeks, although a significantly greater proportion of participants in the RMT group exceeded the minimal clinically important difference (MCID) for disability. The perceived effect of treatment also was significantly higher in the group receiving RMT at two weeks and four weeks, but not 12 weeks. Discussion:  SPT with or without RMT resulted in significant improvements in disability level, pain intensity, pain catastrophizing, and fear avoidance beliefs over 12 weeks in persons with CLBP and movement coordination impairments. RMT resulted in greater perceived effect of treatment, and a clinically meaningful improvement in disability, across four weeks compared to SPT alone.

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)?

• Yes

4. Were study participants and providers blinded to treatment group assignment?

• Yes

5. Were the people assessing the outcomes blinded to the participants’ group assignments?

• Yes

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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?

• Yes

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?

• Yes

Key Finding #1

Manual therapy, including thrust manipulation, applied to the thoracic spine, pelvis, and hips may provide some additional short-term benefits over localized lumbar treatment alone for patients with CLBP and movement coordination impairments.

Key Finding #2

The addition of RMT resulted in a significantly greater magnitude of change in disability level, and a significantly higher perceived change due to treatment, at two weeks and four weeks from the start of care.

Please provide your summary of the paper

This study shows both standard PT and manual therapy improves disability level, pain intensity, pain catastrophizing and fear avoidance beliefs across 12 weeks in patients with chronic LBP. New research shows that doing both manual therapy and exercise has significant benefits in the same outcomes as stated previously. When comparing the application of the 2 different groups (regional manual therapy and standard physical therapy), disability level, fear avoidance beliefs at work, and pain catastrophizing saw more of a decrease in scores in the manual therapy group across each time point (2 weeks, 4 weeks, and 12 weeks). Further, pain intensity saw more of a decrease in the manual therapy group at the 2-week point that then plateaued across 4 weeks and 12 weeks, where then the PT group saw more of a decrease in scores at the 4-week and 12-week mark. The fear avoidance beliefs with physical activity outcome saw more of a decrease in the PT group at the 2-week mark that then plateaued across 4 weeks and 12 weeks, where then the manual therapy group saw more of a decrease in scores at the 4-week and 12-week mark. Lastly, the manual therapy group reported higher perceived levels of effect of treatment when compared to the PT group.

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 standard PT or manual therapy can provide short-term benefits when assessing disability level, pain intensity, fear avoidance at work and doing physical activity, and pain catastrophizing. Both cause decreases in these outcome measures, but manual therapy seems to decrease levels of these outcome measures more than standard PT. However, assessing the use of both would be beneficial to explore whether additional decreases in scores could be made.

Author Names

Fiore, P., Panza, F., Cassatella, G., Russo, A., Frisardi, V., Solfrizzi, V., Ranieri, M., Di Teo, L., & Santamato, A.

Reviewer Name

Jada Holmes, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background. Low back pain (LBP) is a common musculoskeletal disorder that is highly prevalent in the general population. Management of this pathology includes numerous interventions depending on pain severity: analgesic, nonsteroidal anti-inflammatory drugs, steroid injections. However, the effect size and duration of symptom relief are limited. Physical therapy (ultrasound [US], laser therapy, manual therapy, interferential current therapy, Back School, aerobic work, therapeutic aquatic exercise acupuncture) have been reported often with mixed results. Aim. To evaluate the short-term effectiveness of high-intensity laser therapy (HILT) versus ultrasound (US) therapy in the treatment of LBP. Design. Randomized clinical trial. Setting. University hospital. Populations. Thirty patients with LBP were randomly assigned to a HILT group or a US therapy group. Methods. Study participants received fifteen treatment sessions of HILT or US therapy over a period of three consecutive weeks (five days/week). Results. For the 30 study participants there were no between-group differences at baseline in Visual Analogic Scale (VAS) and Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) scores. At the end of the 3-week intervention, participants in the HILT group showed a significantly greater decrease in pain (measured by the VAS) and an improvement of related disability (measured by the OLBPDQ) compared with the group treated with US therapy. Conclusion. Our findings obtained after 15 treatment sessions with the experimental protocol suggested greater effectiveness of HILT than of US therapy in the treatment of LBP, proposing HILT as a promising new therapeutic option into the rehabilitation of 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

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)?

• Yes

4. Were study participants and providers blinded to treatment group assignment?

• Yes

5. Were the people assessing the outcomes blinded to the participants’ group assignments?

• Yes

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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?

• Yes

13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• No

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

Although further studies are needed to confirm the effectiveness of physical therapy interventions in this syndrome, the results of the present study suggested that HILT may have greater benefit in comparison with US therapy in reducing pain and related disability in LBP.

Key Finding #2

The results of the present report are encouraging but other studies with greater samples, longer-term findings, and possible comparisons with other conservative interventions or placebo control groups are needed in the next future.

Please provide your summary of the paper

This study shows that patients with LBP saw a greater reduction in pain and a greater short-term improvement in functionality of the spine when using high-intensity laser therapy (HILT) versus ultrasound therapy (US), as the modalities were only provided to patients 15 times over a 3-week period. However, in previous literature there isn’t evidence for either modality in the results from past studies. Some other studies looked at low-intensity laser therapy (LILT), but still found that there were no significant effects when compared to exercise. HILT quickly reduces inflammation and painful symptomatology. The action of HILT has an analgesic effect, so there’s no evidence of it actually lessening the inflammation of an injury.

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

Previous literature contrasts whether laser therapy or ultrasound therapy is beneficial in treating LBP and seeing improvements in pain or functionality. More studies need to be done before I could recommend this as a standardized treatment for patients with LBP. However, if PTs feel that their patient shows benefits that are worthwhile, then either HILT could be implementing on an individualized basis.

Author Names

Rubinstein, S and Zoete, A and Middlekoop, M and Assendelft, W and Boer, M and Tulder, M

Reviewer Name

Annemarie Jacob

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

The objective of this study was to assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain.  Design Systematic review and meta-analysis of randomised controlled trials.  Data sources Medline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews.  Eligibility criteria for selecting studies Randomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting.  Review methods Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months. Quality of evidence was assessed using GRADE. A random effects model was used and statistical heterogeneity explored.  Results 47 randomised controlled trials including a total of 9211 participants were identified, who were on average middle aged (35-60 years). Most trials compared SMT with recommended therapies. Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief (mean difference −3.17, 95% confidence interval −7.85 to 1.51) and a small, clinically better improvement in function (SMD −0.25, 95% confidence interval −0.41 to −0.09). High quality evidence suggested that compared with non-recommended therapies SMT results in small, not clinically better effects for short term pain relief (mean difference −7.48, −11.50 to −3.47) and small to moderate clinically better improvement in function (SMD −0.41, −0.67 to −0.15). In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy. Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Statistical heterogeneity could not be explained. About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event (relative risk 1.24, 95% confidence interval 0.85 to 1.81) or duration of the event (1.13, 0.59 to 2.18) compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.  Conclusion SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses (6/8)

Key Finding #1

SMT has benefits to the patient but, as it is a passive treatment, should be done as part of a fuller rehab plan to promote patient independence and empowerment

Key Finding #2

Patients should be fully informed on the adverse effects associated with manual therapy, seeing as there is still limited research on the prevalence overall.

Key Finding #3

More data needs to be collected on the specific level of pain relief that was achieved for patients that went through SMT and better understanding of why patients were receiving SMT could strengthen the research on this topic.

Please provide your summary of the paper

From this review, it is clear that there is still an overall lack of evidence on whether SMT is necessary or not. There is also still a lack of evidence apparent on whether the benefits outweigh the risk of musculoskeletal adverse effects when performing manual therapy. However, this review had results that were consistent with other previously done high-quality studies. SMT can have some more benefit over performing non-recommended therapies, but overall effects are similar.

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 confirmed the need to perform SMT as an adjuvant therapy, and not a stand-alone treatment. It is considered a passive intervention and in order to promote patient self-efficacy and growth, it should not be done alone. Specific evidence is still needed to fully understand the pros and cons of this therapy, but overall it is crucial to fully inform your patient on the benefits and potential harms of adverse events associated with SMT, since there is still limited evidence overall.

Author Names

Santos, T.S; Oliveira K.K.B; Martins, L.V; Vidal, A.P.C

Reviewer Name

Jordan Jaklic, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background

Several clinical trials investigated the effectiveness of MT on body posture, but a systematic review grouping the results of these studies was not found in the literature.

Research question

Does manual therapy (MT) cause postural changes?

Methods

Inclusion criteria were: randomized controlled trials in any population; studies in which the primary intervention was the use of any MT technique; studies that evaluated the immediate, short, medium, or long-term effects of interventions on body posture; and studies published in peer-reviewed scientific journals in any year and language. In March 2022, we conducted a search in the PUBMED, Cinahl, Embase, PEDro, and Cochrane Central databases that yielded 6627 articles, of which 38 including 1597 participants were eligible; of these, 35 could be grouped into 12 meta-analyses. The risk of bias was assessed using the PEDro scale and the certainty in the scientific evidence rated through the GRADE system.

Results

The results allowed us to conclude with moderate certainty in the evidence that, when compared to no intervention or sham, in the short and medium term, MT reduced the forward head posture (14 studies, 584 individuals, 95%CI 0.38, 1.06), reduced thoracic kyphosis (5 studies, 217 individuals, 95%CI 0.37, 0.94), improved lateral pelvic tilt (5 studies, 211 individuals, 95%CI 0.11, 0.67) and pelvic torsion (2 studies, 120 individuals, 95%CI 0.44, 1.19) and increased plantar area (3 studies, 134 individuals, 95%CI 0.04, 0.74). With moderate certainty, there was no significant effect on shoulder protrusion (5 studies, 176 individuals, 95%CI −0.11, 0.61), shoulder alignment in the frontal plane (3 studies, 160 individuals, 95%CI −0.15, 0.52), scoliosis (2 studies, 26 individuals, 95%CI −1.57, 2.19), and pelvic anteversion (5 studies, 233 individuals, 95%CI −0.02, 0.51). With low certainty, MT had no effect on scapular upward rotation (2 studies, 74 individuals, 95%CI −0.76, 2.17). With low to very low certainty, it is possible to conclude that MT was not superior to other interventions in the short or medium term regarding the improvement of forward head posture (5 studies, 170 individuals, 95%CI −1.39, 0.67) and shoulder protrusion (3 studies, 94 individuals, 95%CI −4.04, 0.97).  Significance MT can be recommended to improve forward head posture, thoracic kyphosis and pelvic alignment in the short and medium term, but not shoulder posture and scoliosis. MT reduces the height of the plantar arch and this must be taken into account in physical therapy planning. PROSPERO registration number: CRD42021244423.

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

2. Were eligibility criteria for included and excluded studies predefined and specified?

• Yes

3. Did the literature search strategy use a comprehensive, systematic approach?

• Yes

4. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• Yes

5. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• Yes

6. Were the included studies listed along with important characteristics and results of each study?

• Yes

7. Was publication bias assessed?

• Cannot Determine, Not Reported, Not Applicable

8. Was heterogeneity assessed? (This question applies only to meta-analyses.)

• Yes

Key Finding #1

Manual therapy is shown to have an effect on forward head posture and thoracic kyphosis in the short and medium term, suggesting its effects are more likely immediate than cumulative.

Key Finding #2

There is evidence that shows manual therapy can improve frontal plane alignment of the pelvis and increasing plantar support area by correcting muscular imbalances.

Key Finding #3

Manual therapy has not been shown to change pelvic anteversion posture and hyper lordotic posture in the short term.

Key Finding #4

Manual therapy has not been shown to affect the posture of the shoulder or scoliosis in those with a forward head and rounded shoulders posture.

Please provide your summary of the paper

This systematic review/meta-analysis was hard to follow due to the large amount of studies considered with a heterogenous participant pool. Given the explanation about manual therapy addressing muscular imbalances, it is reasonable to see changes in body posture such as arch height and pelvis symmetry. Although manual therapy was concluded to be a short- and medium-term effector, more research needs to be done on manual therapy in the long term. It is possible that a patient’s perception may contribute to long term effectiveness of manual therapy. In regard to body posture, manual therapy was shown to be effective for a forward posture and thoracic kyphosis, but manual therapy was not shown to be any more effective than other interventions or sham interventions.

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

Given that manual therapy was effective in the short and medium term, it may be a way to make patients comfortable, build rapport, and eventually follow it with exercise. However, since manual therapy is not more effective than other interventions, it may be best for some patients to combine manual therapy with exercise and other interventions or forego manual therapy all together.

Forward head posture is common and can be caused by muscular imbalances. According to the meta analysis, manual therapy has worked to correct muscular imbalances in other areas of the body. Manual therapy can be option to correct these imbalances if the patient is comfortable. Clinicians should consider muscular imbalances in upper-crossed syndrome and use manual therapy in the cervical region to target short and tight muscles/lengthened and weak muscles.

A key aspect of the meta analysis was that manual therapy does not work in the long term. If clinicians decide to use manual therapy, there needs to be an intervention given to the patient to use between treatments. Manual therapy coupled with interventions between sessions may be able to make the most difference long term.

Author Names

Sharma, S., Akmal, S., & Sharma, S.

Reviewer Name

Emily LaPlante, LAT, ATC, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: Subacute mechanical low back pain (MLBP) has been found to increase significantly in athletes in the past decade. Manual therapy combined with exercises seems to be promising option; however, its potential effect in athletes is not fully known yet.  Aim: The study aimed to compare between the effects of mulligan sustained natural apophyseal glides (SNAG) combined with exercise, muscle energy technique (MET) combined with exercise therapy and exercise therapy alone on pain, strength and muscle activity in athletes with subacute mechanical low back pain (MLBP).  Methods: The athletes were screened for inclusion into the study using physical examination and Oswestry Disability Index (ODI). The study was a randomized 3 arm repeated measure design and a total of thirty athletes completed the study (n=30). Athletes in group 1 received mulligan sustained natural apophyseal glides (SNAG) combined with exercise, group 2 received muscle energy technique (MET) combined with exercise while those in group 3 were submitted to exercise only. Athletes in all groups received treatment 3 times a week for 4 weeks. The outcome measures were visual analog scale (VAS) scores, back extensor strength and electromyographic (s EMG) muscle activity of longissimus lumborum (LL) and transversus abdominis (Tr A). Results: The VAS score decreased in all three groups (p<0.05); however, group 2 and group 1 were more effective than group 3 (p<0.05). The back extensor strength increased in two groups (p<0.05): group 2 showed a significant increase compared to group 1. The s EMG muscle activity of LL and Tr A increased in two groups (p<0.05): group 2 showed a significant increase compared to group 1. There were significant time, group and interaction effects for the three outcome measures (p<0.05).  Conclusion: The addition of MET combined with exercise therapy reduces pain level, improves back extensor strength and muscle activity of LL and TrA in athletes suffering with subacute MLBP more than mulligan SNAG combined with exercise therapy and exercise therapy alone.

NIH Risk of Bias Tool :

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?

• Yes

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

• Yes

Was the treatment allocation concealed (so that assignments could not be predicted)?

• Yes

Were study participants and providers blinded to treatment group assignment?

• No

Were the people assessing the outcomes blinded to the participants’ group assignments?

• Yes

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

• Yes

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

• Cannot Determine, Not Reported, or Not Applicable

Was there high adherence to the intervention protocols for each treatment group?

• Yes

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

• Cannot Determine, Not Reported, or Not Applicable

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

• Yes

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

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• Yes

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

Were the included studies listed along with important characteristics and results of each study?

• Yes

Key Finding #1

The results of the study found all three groups showed significant improvement in all brain levels.

Key Finding #2

The largest mean difference of pain was demonstrated in the MET combined with exercise followed by the group that performed the mulligan SNAG combined with exercise.

Key Finding #3

Back extensor strength increased in both the MET group and the SNAG group but showed a greater difference in the MET group.

Please provide your summary of the paper

The effects of manual therapy and muscle energy techniques when combined with exercises are unknown in athletes with subacute mechanical low back pain. Nonsurgical strategies for subacute MCLP include rest, physical therapy inclusive of manual therapy, cortisone injections and acupuncture. This study looked at the effect of mulligan SNAG techniques combined with exercise, MET combined with exercise and just exercise on subacute MCLP in the fields of pain and back extensor strength. 35 athletes were recruited for the study and all had to have MLBP from 6-12 weeks and were then randomly divided into one of the three groups. Each group received a total of 12 sessions for 4 weeks by physical therapists with manual therapy certifications. Manual therapy techniques included the SNAG mobilization applied unilaterally and centrally at the lumbar level. Muscle energy techniques performed for the Longissimus lumborum (LL) and transversus abdominis (Tr A). Exercises included abdominal crunches, bridging and pelvic tilting for all groups. Results revealed that MET combined with exercise and mulligan SNAG combined with exercise showed a significant improvement in the outcome measures of pain, back extensor strength and muscle activity of the longissimus lumborum, transversus abdominis in athletes with subacute MLBP.

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

The addition of manual therapy techniques to exercise programs for nonsurgical approaches to treating MLBP in athletes could have a potential benefit over exercise alone. Athletes often are hesitant to limit their sport specific activity levels regardless of pain levels and may find relief with the addition of manual therapy from the physical therapist. Participants in the study were recruited from cricket, hockey, volleyball and basketball and were excluded from the study if there were signs of non-mechanical LBP, neurological deficits, history of spinal surgery, spondylolysis or spondylolisthesis. Future studies may consider the application of MET and SNAG mobilizations with an exercise program as a potential treatment plan for athletes with LBP. In addition, more participants and more sports will be useful in attempting to reproduce the results of this study.

Author Names

Florian Schwerla , Katrin Rother , Denis Rother , Michaela Ruetz and Karl-Ludwig Resch

Reviewer Name

Deja Linton, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

The purpose of this study was to evaluate the effectiveness of osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) in women with persistent LBP and functional disability after childbirth. A pragmatic randomized controlled trial was conducted among a sample of women with a history of pregnancy-related LBP for at least 3 months after delivery. Participants were identified from the general population in Germany. By means of external randomization, women were allocated to an OMTh group and a waitlist control group. Osteopathic manipulative therapy was provided 4 times at intervals of 2 weeks, with a follow-up after 12 weeks. The OMTh was tailored to each participant and based on osteopathic principles. The participants allocated to the control group did not receive OMTh during the 8-week study; rather, they were put on a waiting list to receive OMTh on completion of the study. Further, they were not allowed to receive any additional treatment (ie, medication, physical therapy, or other sources of pain relief) during the study period. The main outcome measures were pain intensity as measured by a visual analog scale and the effect of LBP on daily activities as assessed by the Oswestry Disability Index (ODI). A total of 80 women aged between 23 and 42 years (mean [SD], 33.6 [4.5] years) were included in the study, with 40 in the OMTh group and 40 in the control group. Pain intensity decreased in the OMTh group from 7.3 to 2.0 (95% CI, 4.8-5.9; P<.001) and in the control group from 7.0 to 6.5 (95% CI, -0.2 to -0.9; P=.005). The between-group comparison of changes revealed a statistically significant improvement in pain intensity in the OMTh group (between-group difference of means, 4.8; 95% CI, 4.1-5.4; P<.001) and level of disability (between-group difference of means, 10.6; 95% CI, 9.9-13.2; P<.005). The follow-up assessment in the OMTh group (n=38) showed further improvement. During 8 weeks, OMTh applied 4 times led to clinically relevant positive changes in pain intensity and functional disability in women with postpartum LBP. Further studies that include prolonged follow-up periods are warranted.

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)?

• Yes

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?

• Cannot Determine, Not Reported, or Not Applicable

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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?

• Yes

13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• No

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?

• Yes

Key Finding #1

During the 8 weeks, OMTh applied 4 times led to clinically relevant positive changes in pain intensity and functional disability in women with postpartum LBP

Key Finding #2

In the OMTh group, pain intensity improved by more than 70%. This finding corresponds to an effect size of about 3, which is remarkably high.

Key Finding #3

Analysis of mean VAS and ODI scores at baseline and conclusion of the trial indicate a significant change for the OMTh group and marginal change for the untreated control group.

Please provide your summary of the paper

Low back pain (LBP) is a common complaint among women both during and after pregnancy. The effects of this condition can impact one’s activities of daily living (ADL’s) to the point that quality of life diminishes. This randomized control trial evaluates the possible benefits and effectiveness of osteopathic manipulative therapy (OMTh) by pragmatically modeling the real-life decision of seeking OMTh treatment versus not, aiding in clinical decision-making. While this study had significant strengths (low risk of bias, no adverse outcomes, clinically relevant findings), it also had limitations that include lack of blinding which should be taken into consideration when coupled with self-assessment outcome measures. 

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

The findings of this study may be of interest to any manual therapy practitioners (or other healthcare professionals with the ability to refer patients outward) who are, or intend to, treat persons in the postpartum period. Future studies including prolonged follow-up periods and the effects of specific manipulations may be the fundamental next step to aid in clinical decision-making for both clinicians and patients.

Author Names

Khorsan, R.; Hawk, C.; Lisi, Anthony J.; Kizhakkeveettil, A.

Reviewer Name

Deja Linton, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

The objective of this review is to evaluate the evidence on the effects of Spinal Manipulative Therapy (SMT) on back pain and other related symptoms during pregnancy. A literature search was conducted using Pubmed, Manual, Alternative and Natural Therapy Index System, Cumulated Index to Nursing and Allied Health, Index to Chiropractic Literature, the Cochrane Library, and Google Scholar. In addition hand searches and reference tracking were also performed, and the citation list was assessed for comprehensiveness by content experts. This review was limited to peer-reviewed manuscripts published in English from 1966 until September 2008. The initial search strategy yielded 140 citations of which 12 studies were reviewed for quality. The methodological quality of the included studies was assessed independently using quality checklists of the Scottish Intercollegiate Guidelines Network and Council on Chiropractic Guidelines and Practice Parameters. The review indicates that the use of SMT during pregnancy to reduce back pain and other related symptoms is supported by limited evidence. Overall, this body of evidence is best described as emergent. However, since effective treatments for pregnancy-related back pain are limited, clinicians may want to consider SMT as a treatment option, if no contraindications are present.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses

Is the review based on a focused question that is adequately formulated and described?

• No

Were eligibility criteria for included and excluded studies predefined and specified?

• Yes

Did the literature search strategy use a comprehensive, systematic approach?

• Yes

Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• Yes

Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• Yes

Were the included studies listed along with important characteristics and results of each study?

Was publication bias assessed?

• Yes

Was heterogeneity assessed? (This question applies only to meta-analyses.)

• Not Applicable

Key Finding #1

At the time of publication, evidence to support manipulative therapies during pregnancy to reduce back pain and other symptoms was limited.

Key Finding #2

While there was no definitive evidence supporting the effectiveness of this treatment, there was also no definitive evidence supporting a lack of effectiveness.

Key Finding #3

The treatment options for low back pain in pregnancy are limited.

Key Finding #4

Research available on the use of manipulative therapies during pregnancy could be described as emergent at best.

Please provide your summary of the paper

Majority of women experience some form of musculoskeletal pain or related symptoms during their pregnancy. This systematic review was performed in an attempt to evaluate evidence of the effects of spinal manipulative therapy (SMT) on back pain and other related symptoms experienced during pregnancy. This was accomplished by evaluating peer-reviewed manuscripts ranging from the mid 1960s to the late 2000s. Both available research and evidence on the effectiveness of this treatment were limited at the time of publication. While the reviewed publications failed to prove significant effectiveness, they also failed to prove any lack thereof. The resulting conclusion is that the research surrounding this treatment method is emergent at best and requires further development.

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

The findings of this review may be of interest to any manual therapy practitioners (or other healthcare professionals with the ability to refer patients outward) who are, or intend to, treat persons in the postpartum period. Exploration of definitive effects of manipulative therapies continues to be limited by the scarcity of literature. Future trials and studies are needed with larger sample sizes, longer durationo f follow-up, control of co-interventions, in-detail descriptions of manipulative therapy procedures, and much more to fully investigate the eeffectiveness of this treatment option.

Author Names

Danazumi, M; Bello, B; Yakasai, A; Kaka, B

Reviewer Name

Adrienne Maniktala, LAT, ATC

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Context: Evidence has shown that spinal mobilization with leg movement (SMWLM) and progressive inhibition of neuromuscular structures (PINS) are individually effective in the management of lumbar radiculopathy. However, previous evidence reported data for only a short-term study period and did not investigate the effect of the combined manual therapy techniques. Objectives: To compare the combined effects of two manual therapy techniques (SMWLM and PINS) with the individual techniques alone (SMWLM or PINS) in the management of individuals with lumbar radiculopathy. Methods: A total of 60 patients diagnosed with unilateral lumbar radiculopathy secondary to disc herniation were randomly allocated into three groups: 20 participants each in the SMWLM, PINS, and combined SMWLM + PINS groups. Each group attended two treatments per week for 30 min each, for three months. Participants were assessed at baseline, immediately posttreatment, and then at three, six, and nine months follow-up using the Visual Analog Scale (VAS), Rolland-Morris Disability Questionnaire (RMDQ), and Sciatica Bothersomeness Index (SBI). Results: Between-groups analyses using a two-way repeated-measures analysis of variance indicated significant interactions between groups and follow-up times for all outcomes (p=0.001). Participants receiving combined SMWLM + PINS treatment experienced greater improvement in leg pain, back pain, disability, and sciatica at all timelines (immediately posttreatment, and three, six, and nine months follow-up) than the participants receiving SMWLM or PINS alone (p<0.05). However, participants receiving SMWLM alone showed better improvement than the participants receiving PINS alone at all timelines (p<0.05). Conclusions: A combined SMWLM + PINS treatment protocol showed greater improvement than the individual techniques alone in the management of individuals with LR in this study.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT

• Yes

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

• Yes

Was the treatment allocation concealed (so that assignments could not be predicted)?

• Yes

Were study participants and providers blinded to treatment group assignment?

• No

Were the people assessing the outcomes blinded to the participants’ group assignments?

• Yes

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

• Yes

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

• Yes

Was there high adherence to the intervention protocols for each treatment group?

• Yes

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

• Yes 

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

• Yes

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

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• Yes

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

Patients receiving the combined treatment of SMWLM and PINS, resulted in improvement in leg pain, back pain, disability and sciatica at all of the timeline assessments.

Key Finding #2

Patients receiving only SMWLM showed better improvement than patients receiving only PINS at all of the timeline assessments.

Key Finding #3

The addition of the home exercise plan with the combined treatment of SMWLM and PINS showed greater improvements.

Please provide your summary of the paper

Low back pain has been determined as one of the most common conditions seen in patients. Previous studies for lumbar radiculopathy have shown that SMWLM relieves nerve compression and PINS relaxes reflex activity in the neuromuscular structures. This study analyzed information achieved from previous studies of SMWLM and PINS treatment for lumbar radiculopathy to determine if the combination of these two treatments and the addition of therapeutic exercise would develop better results initially and long-term. The study was able to prove that the combination SMWLM and PINS with therapeutic exercise had greater improvement in all of the outcomes at all of the different timeline assessments, but also that all three groups showed improvements in general at all timeline assessments. The patients in the combined group with exercise were also categorized to have a higher mean BMI compared to the other group’s patients. They also determined that the SMWLM only group had greater improvement compared to the PINS groups because of the PA glides, proven to relieve pressure off the nerves thus decreasing pain, that was associated with the SMWLM. Additionally, the study concluded that the therapeutic exercises could not be used as a single intervention for lumbar radiculopathy.

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 will be helpful for clinical approach because lumbar radiculopathy is a very common condition seen among patients. A limitation of this study includes not assessing the psychosocial components that are most associated with low back pain. Additionally, the study assessed therapeutic exercise combined with the different mobilization groups but, stated that the use of therapeutic exercise only would not be beneficial for this patient population and did not state why. Despite their limitations the results achieved from this study helps clinicians to focus their treatment more to improve pain associated with the condition.

Author Names

Coulter, I; Crawford, C; Hurwitz, E; Vernon, H; Khorsan, R; Booth, M; Herman, P

Reviewer Name

Giulia Marsella, Duke SPT Class of 2024

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

The purpose of this study is to determine the efficacy, effectiveness and safety of various mobilization and manipulation therapies for treatment of chronic low back pain. The study design is a systemic literature review and meta-analysis; the study measures self-reported pain, function, health-related quality of life and adverse events. We searched multiple electronic databases from January 2000 to March 2017 and selected randomized controlled trials comparing manipulation or mobilization therapies with sham, no treatment, other active therapies, and multimodal therapeutic approaches. 51 trials were included in the systematic review and 9 trials were judged similar enough to be pooled for meta-analysis. Mobilization interventions, compared with other active comparators including exercise regimens, significantly reduced pain but not disability, while manipulation significantly reduced pain and disability, compared with other active comparators including exercise and therapy. Overall, there is moderate-quality evidence that manipulation and mobilization are likely to reduce pain and improve function for patients with low back pain; manipulation appears to produce a larger effect than mobilization.

NIH Risk of Bias Tool
Quality Assessment of Systematic Reviews and Meta-Analyses

Key Finding #1

Thrust (manipulation) or non-thrust (mobilization) interventions were statistically significant for
the reduction of pain and disability when compared to active counterparts of exercise or
physical therapy.

Key Finding #2

Subgroup meta-analyses data favored thrust intervention over non-thrust intervention for pain
reduction in patients with chronic low back pain.

Key Finding #3

Subgroup meta-analysis data favored thrust intervention for the reduction in disability when
compared to active counterparts, yet non-thrust interventions were not statistically significant
when compared to active counterparts.

Key Finding #4

Thrust interventions had an increasing effect at both 3 and 6 month follow-up for pain and
disability reduction, while non-thrust interventions did not from post-treatment.

Please provide your summary of the paper.

This study included unimodal randomized control trials in a systematic review to compare thrust and non-thrust interventions to active therapy of exercise or physical therapy, which yielded moderate evidence in support of both thrust and non-thrust interventions. There was intentional exclusion of multimodal studies and studies analyzing the relationship between dose and outcomes due to unwanted heterogeneity.

Standardized mean differences (SMDs) using REVMAN were utilized for the meta-analysis. Pain and disability outcomes were rendered into VAS and Roland-Morris Disability Questionnaire for interpretation across studies.

This study has high external validity, meaning the study participants reflect the population of interest and high model validity, making the results less real-world applicable. Some weaknesses were data limitations and insufficient similar studies. The data limitations made it challenging to draw conclusions on patient’s health-related quality of life and insufficient similar studies made it challenging to pool data across subgroups. The strengths of this study include low risk bias across studies, clear and defined eligibility criteria of chronic low back pain, 3 and 6 month follow-up of patients, and unimodal comparison for the systemic review to avoid heterogeneity.

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 has the potential to directly impact care of patients with chronic low back pain, which according to this study, may have a lifetime prevalence rate up to 84% in the U.S. This moderate quality evidence in support of mobilization and manipulation can encourage the use of manual therapy in conjunction with other active treatment. Manipulation specifically demonstrated larger effects than mobilization, which supports the use of thrust techniques in clinical practice in patients with chronic low back pain.

Author Names

Stevinson, C., Ernst, E.

Reviewer Name

Mallory Martlock SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

The aim of this systematic review was to summarize the evidence about the risks of spinal manipulation. Articles were located through searching three electronic databases (MEDLINE, EMBASE, Cochrane Library), contacting experts (n =9), scanning reference lists of relevant articles, and searching departmental files. Reports in any language containing data relating to risks associated with spinal manipulation were included, irrespective of the profession of the therapist. Where available, systematic reviews were used as the basis of this article. All papers were evaluated independently by the authors. Data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.  Spinal manipulation is practiced by chiropractors, osteopathic physicians, physiotherapists, physicians, and other health care providers. It is a manual form of treatment aimed mainly at reducing spinal (and other joint) pain and increasing range of motion. It often involves a high velocity thrust, a technique in which the joints are adjusted rapidly, often accompanied by popping or snapping sounds. The technique results in transient stretching of joint capsules and is believed to reset the position of the spinal cord and nerves, allowing the nervous system to function optimally and improve the body’s biomechanical efficiency (1). The thrust is exerted through either a long lever arm, in which force is applied distant from the joint, or a short lever arm, when force is applied close to the joint. Although spinal manipulation is deemed by experts to be an effective form of treating back pain (2), the evidence from randomized clinical trials remains contradictory 3, 4, 5.  The use of spinal manipulation differs considerably according to time and location. One-year usage rates from 7% (1997, United States), 10% (1998, Austria), 15% (1996, Australia), 16% (1998, United States), to 33% (1996, United Kingdom) have been reported (6). Given its popularity, it seems imperative to define the risks of spinal manipulation as closely as possible.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses

Is the review based on a focused question that is adequately formulated and described?

• Yes

Were eligibility criteria for included and excluded studies predefined and specified?

• No

Did the literature search strategy use a comprehensive, systematic approach?

• Yes

Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• No

Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• No

Were the included studies listed along with important characteristics and results of each study?

Was publication bias assessed?

• Cannot Determine, Not Reported, Not Applicable

Was heterogeneity assessed? (This question applies only to meta-analyses.)

• Cannot Determine, Not Reported, Not Applicable

Key Finding #1

Spinal manipulation is frequently associated with non-serious adverse events and rarely associated with serious adverse events.

Key Finding #2

Many studies argued that there is far less risk associated with spinal manipulation compared to other treatments for the same conditions (ex. NSAIDs).

Key Finding #3

The most common minor adverse event reported was local discomfort which was found to be more common than any serious adverse event which included vertebrobasilar accidents, disc herniations, cauda equina and other cerebral complications.

Please provide your summary of the paper

This paper reviewed articles found from MEDLINE, EMBASE and Cochrane Library based on the search terms “adverse effects, adverse events, chiropractic, complications, manual therapy, osteopathy, risk, safety, spinal manipulation, stroke and vascular accident”. The article also consulted nine experts. After reviewing the articles, the systematic review concluded that more non serious adverse events occurred after spinal manipulation compared with serious adverse events. The evidence found was anecdotal and often incomplete so it was hard to understand if the spinal manipulation was always the cause of the adverse event, whether serious or non serious. The article also touched on the evidence that was found stating that other treatments (NSAIDs) for the same condition (low back pain) were potentially more dangerous than spinal manipulation. The article concluded that serious events following spinal manipulation were rare and continued to emphasize the important of having patient consent and informing them of the risks prior to treatment.

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 is a useful resource to help better understand some of the adverse events associated with spinal manipulation and how often they occur in clinical practice. Since this review was completed in 2002, it would be interesting to see if there was more recent evidence, either for or against spinal manipulation, that differed greatly from the information found in this article. However, this review is helpful in providing evidence that serious adverse events are rare in the implementation of spinal manipulation, which can have a direct impact on clinical practice by supporting manual therapy as a treatment option. The article still emphasized the importance of informing the patient of what spinal manipulation is and the risks associated with it before gaining their consent. This is an important aspect of implementing spinal manipulation into clinical practice and should constantly be a priority for clinicians when prescribing this treatment.

Author Names

Jung, A;  Adamczyk, W; Ahmed, A; van der Schalk, L; Poesl, M; Luedtke, K; Szikszay, T

Reviewer Name

Rachel Plzak; Student Physical Therapist

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Spinal manual therapy (SMT) is often used to treat patients with spinal disorders; however, the underlying mechanisms of SMT are not fully understood. This systematic review and meta-analysis investigates the effect of SMT compared to sham treatment or no intervention on local or remote (segmental or nonsegmental) pressure pain thresholds (PPT) in patients with chronic musculoskeletal conditions and people who are pain free.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses

Is the review based on a focused question that is adequately formulated and described?

• Yes

Were eligibility criteria for included and excluded studies predefined and specified?

• Yes

Did the literature search strategy use a comprehensive, systematic approach?

• Yes

Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• Yes

Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• Yes

Were the included studies listed along with important characteristics and results of each study?

Was publication bias assessed?

• Yes

Was heterogeneity assessed? (This question applies only to meta-analyses.)

• Yes

Key Finding #1

The study found that spinal manual therapy provided no immediate hypoalgesic effect on pressure pain thresholds in participants with chronic pain disorders or those who were pain free.

Key Finding #2

It should be noted that the studies selected for this systematic review and meta-analysis had varying control groups. Some control groups received no treatment, while others received sham treatments.

Please provide your summary of the paper

This paper found no significant or meaningful difference between spinal manual therapy and control treatments (no treatment or sham treatments) on patients with either chronic pain disorders or those who were pain free. As stated above, it is important to note the the varying control treatments among the different studies reviewed, as this could influence the overall results of this paper. The immediate hypoalgesic effects studied were measured using pain pressure thresholds.

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

I found this systematic review and meta-analysis very interesting as it did not find significant immediate hypoalgesic effects of spinal manual therapy. It led me to think about the purpose behind using spinal manual therapy on patients, and whether the treatment was primarily used for pain relief or for other benefits. I think this is something important to think about and keep in mind when working with patients, especially those with chronic pain disorders. I believe there is value in more studies being conducted to further investigate the immediate hypoalgesic effects of spinal manual therapy.

Author Names

Hall H, Cramer H, Sundberg T, Ward L, Adams J, Moore C, Sibbritt D, Lauche R

Reviewer Name

Aria Mathew

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Study Design

Systematic Review with Meta-Analysis

Abstract:

Objective: The aim of this systematically review was to critically appraise and synthesize the best available evidence regarding the effectiveness of manual therapies for managing pregnancy-related low back and pelvic pain.

Methods: Seven databases were searched from their inception until April 2015 for randomized controlled trials. Studies investigating the effectiveness of massage and chiropractic and osteopathic therapies were included. The study population was pregnant women of any age and at any time during the antenatal period. Study selection, data extraction, and assessment of risk of bias were conducted by 2 reviewers independently, using the Cochrane tool. Separate meta-analyses were conducted to compare manual therapies to different control interventions.

Results: Out of 348 nonduplicate records, 11 articles reporting on 10 studies on a total of 1198 pregnant women were included in this meta-analysis. The therapeutic interventions predominantly involved massage and osteopathic manipulative therapy. Meta-analyses found positive effects for manual therapy on pain intensity when compared to usual care and relaxation but not when compared to sham interventions. Acceptability did not differ between manual therapy and usual care or sham interventions.

Conclusions: There is currently limited evidence to support the use of complementary manual therapies as an option for managing low back and pelvic pain during pregnancy. Considering the lack of effect compared to sham interventions, further high-quality research is needed to determine causal effects, the influence of the therapist on the perceived effectiveness of treatments, and adequate dose–response of complementary manual therapies on low back and pelvic pain outcomes during pregnancy.

NIH Risk of Bias Score: 8/8 (Low risk of bias)

Key Finding #1

Results from the systematic review indicated a moderate effect of manual therapies for decreasing pain in comparison to usual care and relaxation, however, there were no positive effects for manual therapies in decreasing pain when compared to sham interventions.

Key Finding #2

Positive results were found with craniosacral techniques and osteopathy in decreasing pain disability, which is consistent with findings in a recent Cochrane review.

Key Finding #3

The process of having an intervention conducted on the individual (versus a self-conducted intervention) may have influenced the perceived effectiveness of the treatment, suggesting a “practitioner effect”.

Reviewer Summary: After reviewing the results included in the meta-analysis, there does seem to be a positive effect of manual therapy on pain intensity in pregnant women. However, it is uncertain if these results are due to the “practitioner effect” or the specific intervention itself. For example, when comparing manual therapies with sham interventions, pain reduction was similar, suggesting the importance of therapeutic activities regardless of type. Few adverse effects of manual therapy were reported. Due to the safety and effectiveness in treating low back pain and pelvic girdle pain in pregnant women, manual therapy is recommended.

Clinical Implication: Because of its effectiveness in decreasing low back and pelvic pain, manual therapy is a recommended option when treating pregnant women. The therapist should be aware that these results could be due to the “practitioner effect” versus the effectiveness of the specific intervention itself. Therapists should evaluate the need for manual therapy and assess each patient’s needs on an individual basis.

Author Names

Smith C, Levett K, Collins C, Dahlen H, Ee C, Suganuma M

Reviewer Name

Aria Mathew

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Study Design

Systematic Review

Abstract:

Background: Many women would like to avoid pharmacological or invasive methods of pain management in labour, and this may contribute towards the popularity of complementary methods of pain management. This review examined the evidence currently available on manual methods, including massage and reflexology, for pain management in labour. This review is an update of the review first published in 2012.

Objectives: To assess the effect, safety and acceptability of massage, reflexology and other manual methods to manage pain in labour.

Search methods: For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register (30 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6), MEDLINE (1966 to 30 June 2017, CINAHL (1980 to 30 June 2017), the Australian New Zealand Clinical Trials Registry (4 August 2017), Chinese Clinical Trial Registry (4 August 2017), ClinicalTrials.gov, (4 August 2017), the National Center for Complementary and Integrative Health (4 August 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (4 August 2017) and reference lists of retrieved trials.

Selection criteria: We included randomised controlled trials comparing manual methods with standard care, other non‐pharmacological forms of pain management in labour, no treatment or placebo. We searched for trials of the following modalities: massage, warm packs, thermal manual methods, reflexology, chiropractic, osteopathy, musculo‐skeletal manipulation, deep tissue massage, neuro‐muscular therapy, shiatsu, tuina, trigger point therapy, myotherapy and zero balancing. We excluded trials for pain management relating to hypnosis, aromatherapy, acupuncture and acupressure; these are included in other Cochrane reviews.

Data collection and analysis: Two review authors independently assessed trial quality, extracted data and checked data for accuracy. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE approach.

Main results: We included a total of 14 trials; 10 of these (1055 women) contributed data to meta‐analysis. Four trials, involving 274 women, met our inclusion criteria but did not contribute data to the review. Over half the trials had a low risk of bias for random sequence generation and attrition bias. The majority of trials had a high risk of performance bias and detection bias, and an unclear risk of reporting bias. We found no trials examining the effectiveness of reflexology.

Massage: We found low‐quality evidence that massage provided a greater reduction in pain intensity (measured using self‐reported pain scales) than usual care during the first stage of labour (standardised mean difference (SMD) −0.81, 95% confidence interval (CI) −1.06 to −0.56, six trials, 362 women). Two trials reported on pain intensity during the second and third stages of labour, and there was evidence of a reduction in pain scores in favour of massage (SMD −0.98, 95% CI −2.23 to 0.26, 124 women; and SMD −1.03, 95% CI −2.17 to 0.11, 122 women). There was very low‐quality evidence showing no clear benefit of massage over usual care for the length of labour (in minutes) (mean difference (MD) 20.64, 95% CI −58.24 to 99.52, six trials, 514 women), and pharmacological pain relief (average risk ratio (RR) 0.81, 95% CI 0.37 to 1.74, four trials, 105 women). There was very low‐quality evidence showing no clear benefit of massage for assisted vaginal birth (average RR 0.71, 95% CI 0.44 to 1.13, four trials, 368 women) and caesarean section (RR 0.75, 95% CI 0.51 to 1.09, six trials, 514 women). One trial reported less anxiety during the first stage of labour for women receiving massage (MD ‐16.27, 95% CI −27.03 to −5.51, 60 women). One trial found an increased sense of control from massage (MD 14.05, 95% CI 3.77 to 24.33, 124 women, low‐quality evidence). Two trials examining satisfaction with the childbirth experience reported data on different scales; both found more satisfaction with massage, although the evidence was low quality in one study and very low in the other.

Warm packs: We found very low‐quality evidence for reduced pain (Visual Analogue Scale/VAS) in the first stage of labour (SMD −0.59, 95% CI −1.18 to −0.00, three trials, 191 women), and the second stage of labour (SMD −1.49, 95% CI −2.85 to −0.13, two trials, 128 women). Very low‐quality evidence showed reduced length of labour (minutes) in the warm‐pack group (MD −66.15, 95% CI −91.83 to −40.47; two trials; 128 women).

Thermal manual methods: One trial evaluated thermal manual methods versus usual care and found very low‐quality evidence of reduced pain intensity during the first phase of labour for women receiving thermal methods (MD −1.44, 95% CI −2.24 to −0.65, one trial, 96 women). There was a reduction in the length of labour (minutes) (MD −78.24, 95% CI −118.75 to −37.73, one trial, 96 women, very low‐quality evidence). There was no clear difference for assisted vaginal birth (very low‐quality evidence). Results were similar for cold packs versus usual care, and intermittent hot and cold packs versus usual care, for pain intensity, length of labour and assisted vaginal birth.

Music: One trial that compared manual methods with music found very low‐quality evidence of reduced pain intensity during labour in the massage group (RR 0.40, 95% CI 0.18 to 0.89, 101 women). There was no evidence of benefit for reduced use of pharmacological pain relief (RR 0.41, 95% CI 0.16 to 1.08, very low‐quality evidence).

Of the seven outcomes we assessed using GRADE, only pain intensity was reported in all comparisons. Satisfaction with the childbirth experience, sense of control, and caesarean section were rarely reported in any of the comparisons.

Authors’ conclusions: Massage, warm pack and thermal manual methods may have a role in reducing pain, reducing length of labour and improving women’s sense of control and emotional experience of labour, although the quality of evidence varies from low to very low and few trials reported on the key GRADE outcomes. Few trials reported on safety as an outcome. There is a need for further research to address these outcomes and to examine the effectiveness and efficacy of these manual methods for pain management.

NIH Risk of Bias Score: 8/8 (Low risk of bias)

Key Finding #1

Manual therapy such as massage, warm packs, and thermal manual methods may have an analgesic effect on pain during labor, however the quality of evidence used to form these conclusions are low.

Key Finding #2

Manual therapy may have an impact on improving a woman’s sense of control and emotional experience during labor.

Key Finding #3

Personal control and decision making are related to satisfaction with the childbirth experience

Reviewer Summary: Pain management interventions often used during labor include mind-body interventions, traditional medicine, manual therapy, and pharmacologic treatments. This systematic review included studies on the use of these interventions and their effects on pain intensity. Although manual therapy such as massage, warm packs, and thermal manual methods may have an analgesic effect on pain during labor, the studies that were conducted were of low quality, and more research needs to be performed to determine the relationship between manual therapy and pain management during labor.

Clinical Implication: Therapists might find manual therapy to be useful when treating patients during labor (or immediately before), however, interventions must be patient specific.

Author Names

Nejati, P., Safarcherati, A., & Karimi, F.

Reviewer Name

Haley Mills, SPT, BS Exercise Physiology

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: The sacroiliac joint dysfunction (SIJD) has been found to be the primary culprit for lower back pain (LBP), but it is still overlooked and treated as LBP. There are no guidelines or appropriate therapeutic protocols for SIJD. Thus, there is a need for an effective treatment strategy for SIJD. Objective: To compare exercise therapy (ET), manipulation therapy (MT), and a combination of the 2 (EMT) in terms of their effectiveness in treating SIJD. Study Design: A comparative, prospective, single-blind randomized controlled trial. Setting: Sports Medicine Department of Rasoul Akram Hospital. Methods: A total of 51 patients with lower back or buttock pain resulting from SIJD were randomly assigned to 1 of 3 study groups: ET, MT, or EMT. The ET group received posterior innominate self-mobilization, sacroiliac joint stretching, and spinal stabilization exercises. The MT group underwent posterior innominate mobilization and SIJ manipulation. Lastly, the EMT group received manipulation maneuvers followed by exercise therapy. Pain and disability were assessed at 6, 12, and 24 weeks after the interventions. Results: All 3 groups demonstrated significant improvement in pain and disability scores compared to the baseline (P < 0.05). The difference among these therapeutic protocols was found to be a function of time. At week 6, MT showed notable results, but at week 12, the effect of ET was remarkable. Finally, at week 24, no significant difference was observed among the study groups. Limitations: A major limitation of the present study is lack of a control group receiving a type of intervention other than the experimental protocols. Another limitation is the short duration of follow-ups. Conclusions: Exercise and manipulation therapy appear to be effective in reducing pain and disability in patients with SIJD. However, the combination of these 2 therapies does not seem to bring about significantly better therapeutic results than either approach implemented separately. Key words: Exercise therapy, manipulation therapy, sacroiliac joint dysfunction

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?

• Cannot Determine, Not Reported, or Not Applicable

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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?

• Cannot Determine, Not Reported, or Not Applicable

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?

• No

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?

• Yes

Key Finding #1

All three treatment options succeeded in relieving pain and improving functionality for a period of 24 weeks compared to baseline.

Key Finding #2

The therapeutic effect of manual therapy appeared more quickly (at week 6) than exercise therapy alone.

Key Finding #3

Exercise therapy proved to be more effective in improving functionality at week 12 than manual therapy alone.

Key Finding #4

No significant difference observed between exercise therapy, manual therapy, or exercise therapy and manual therapy after 6 weeks.

Please provide your summary of the paper

This single-blind randomized controlled trial followed 56 patients with SI joint dysfunction (SIJD) over a 24-week span. They assessed effects at 6, 12, and 24 weeks to discover the impact, immediately and over time, of exercise therapy and manual therapy combined versus manual therapy or exercise therapy alone on SIJD. The exercise therapy group performed assigned exercises at home and at one in-person office visit per week. The manual therapy group received 2 maneuvers from the same clinician each session, with the clinician repeating the maneuvers until the patient scored negatively on the Standing Forward Bending Test and the Gillet Test. The manual therapy and exercise therapy combined group received both interventions with the same parameters as noted above. The Visual Analog Scale, Oswestry Disability Index, and Roland Morris Back Pain Questionnaire were used to subjectively assess effects, while the timed up-and-go and self-paced walk tests were used to objectively assess effects. Results were recorded before intervention and at the 6, 12, and 24-week marks. At the 6-week mark, the manual therapy showed better results than both other groups, however, at the 12-week mark the exercise therapy group demonstrated better results. Finally, at the 24-week mark, there were no significant differences between results in the three groups. All three methods can be effective at reducing pain caused by SIJD but the researchers noted that a combination of manual therapy and exercise therapy would likely be the most effective to inact early improvements from the manual therapy intervention and lasting improvements from the exercise therapy intervention.

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 is one of the first to assess the effects of manual therapy as compared to other treatment methods for SI joint dysfunction. While the pool of information is slightly larger for vague LBP, this article takes a specific focus that will likely be very helpful for clinicians treating patients with SI joint dysfunction. While the study may be missing a few nuances surrounding methods, it remains one of the only studies that offers research in this area and therefore can be considered a valuable resource.

Author Names

McCarthy, C., Potter, L., Oldham, J.

Reviewer Name

Miles Moore, SPT CSCS

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: Spinal manipulation is commonly used to treat back pain. The application of spinal manipulation has traditionally involved an element of targeting the technique to a level of the spine where the proposed movement dysfunction is sited. We evaluated the effects of a targeted manipulative thrust versus a thrust applied generally to the lumbar region.  Methods: A randomized controlled clinical trial in patients with low back pain following CONSORT (Consolidated Standards of Reporting Trials) guidelines. Sixty subjects were randomly allocated to two groups: one group received a targeted manipulative thrust (n=29) and the other a general manipulation thrust (GT) (n=31) to the lumbar spine. Thrust was either localized to a clinician-defined symptomatic spinal level or an equal force was applied through the whole lumbosacral region. We measured pressure-pain thresholds (PPTs) using algometry and muscle activity (magnitude of stretch reflex) via surface electromyography. Numerical ratings of pain and Oswestry Disability Index scores were collected.  Results: Repeated measures of analysis of covariance revealed no between-group differences in self-reported pain or PPT for any of the muscles studied.  Summary: A GT procedure-applied without any specific targeting-was as effective in reducing participants’ pain scores as targeted approaches.  Trial registration number: ISRCTN11994230.

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)?

• Yes

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?

• Cannot Determine, Not Reported, or Not Applicable

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

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?

• No

13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• Cannot Determine, Not Reported, or Not Applicable

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?

• Yes

Key Finding #1

There were no differences in disability or pain reduction between the targeted thrust manipulation group and the general thrust manipulation group.

Key Finding #2

There was an increase in stretch reflex surface EMG measurement in lumbar multifidus muscles on the targeted thrust manipulation group across three visits.

Key Finding #3

Targeting a manipulative thrust technique to a clinically-defined, specific level of the lumbar spine does not improve self-reported pain or disability levels.

Key Finding #4

It may be necessary for manual therapy scientists to reevaluate paradigms used to justify therapeutic mechanisms of spinal manipulations and the clinical utility of specialized manipulation training.

Please provide your summary of the paper

The results showed that there was no significant difference in disability level or pain reduction between the targeted thrust (TT) spinal manipulation (SM) group and general thrust (GT) spinal manipulation applied to the lumbar region group. Pre- and post-treatment pain levels were documented using the Visual Analogue Scale (VAS) and algometry was used to assess the pressure-pain threshold (PPT) at the center of the muscle belly being evaluated by surface EMG (sEMG) (iliocostalis and local multifidus). Additionally, there was no significant difference in the magnitude or acceleration of the SM thrust between groups. The results show that TT spinal manipulations amplified the local stretch-reflex response of tested muscle bellies measured by sEMG, however, this could be due to protective muscle activation by participants anticipating TT manipulation to specific areas as they participated in sequential sessions.   These results call into question the need for comprehensive, hands-on SM training in TT manipulation as GT and TT generated equivocal results in disability and pain reduction. If the benefits of SM can be generated through GT intervention, physical therapists without extensive targeted spinal segment manipulation training can provide GT to patients and expect similar outcomes compared to therapists using TT. These findings broadly allow more low back pain patients to receive beneficial SM treatment as therapists won’t have to complete comprehensive training to gain competency using a technique (TT) that was thought to yield superior results.   This study does have several limitations. The study is slightly underpowered, thus, increasing the chance of a false negative. Additionally, this is study is a single-blind study as the spinal manipulator knew which thrust group each subject was allocated into so that the appropriate SM could be applied. This may have introduced bias, impacting the relationship between the manipulator and the subject.

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

Clinically, this allows me to appreciate the ambiguity and complexity of manual therapy treatment mechanisms. The results show similar outcomes between general and targeted thrust techniques, potentially allowing clinicians to save time searching for specific spinal segments contributing to pain. Additionally, these results challenge the clinical utility of extensive specialized, targeted spinal manipulation training if similar outcomes are achieved with broad force thrust techniques. According to the study’s results, therapists could save time locating spinal segment pain generators and more time applying general thrust spinal manipulation techniques or using other interventions in practice.

Author Names

Menke, J

Reviewer Name

Miles Moore, SPT CSCS

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Study design: Meta-analysis methodology was extended to derive comparative effectiveness information on spinal manipulation for low back pain.

Objective: Determine relative effectiveness of spinal manipulation therapies (SMTs), medical management, physical therapies, and exercise for acute and chronic nonsurgical low back pain.

Summary of background data: Results of spinal manipulation treatments of nonsurgical low back pain are equivocal. Nearly 40 years of SMT studies were not informative. Methods: Studies were chosen on the basis of inclusion in prior evidence syntheses. Effect sizes were converted to standardized mean effect sizes and probabilities of recovery. Nested model comparisons isolated nonspecific from treatment effects. Aggregate data were tested for evidential support as compared with shams. Results: Of 84% acute pain variance, 81% was from nonspecific factors and 3% from treatment. No treatment for acute pain exceeded sham’s effectiveness. Most acute results were within 95% confidence bands of that predicted by natural history alone. For chronic pain, 66% of 98% was nonspecific, but treatments influenced 32% of outcomes. Chronic pain treatments also fit within 95% confidence bands as predicted by natural history. Though the evidential support for treating chronic back pain as compared with sham groups was weak, chronic pain seemed to respond to SMT, whereas whole systems of clinical management did not. Conclusion: Meta-analyses can extract comparative effectiveness information from existing literature. The relatively small portion of outcomes attributable to treatment explains why past research results fail to converge on stable estimates. The probability of treatment superiority matched a binomial random process. Treatments serve to motivate, reassure, and calibrate patient expectations–features that might reduce medicalization and augment self-care. Exercise with authoritative support is an effective strategy for acute and chronic low back pain.

NIH Risk of Bias Tool

Quality Assessment of Systematic Reviews and Meta-Analyses

Is the review based on a focused question that is adequately formulated and described?

• Yes

Were eligibility criteria for included and excluded studies predefined and specified?

• No

Did the literature search strategy use a comprehensive, systematic approach?

• No

Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• No

Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• Yes

Were the included studies listed along with important characteristics and results of each study?

Was publication bias assessed?

• No

Was heterogeneity assessed? (This question applies only to meta-analyses.)

• No

Key Finding #1

Change in pain levels for acute low back pain cases occurred in 84% of cases, and 81% of those changes were attributed to nonspecific factors.

Key Finding #2

Change in pain levels for chronic low back pain cases occurred in 98% of cases, 66% of change was attributed to nonspecific factors and 32% was attributed to treatment. Chronic low back pain seems to respond to spinal manipulative therapies.

Key Finding #3

Natural history appears to be more effective than current treatments for acute or chronic low back pain.

Key Finding #4

Patients receiving sham treatments consistently improved while wait-list patients continued to get worse. This illustrates the importance and value of seeing and attending to patients and the beneficial impact it can have on outcomes.

Please provide your summary of the paper

The following paper addresses the efficacy of spinal manipulative therapies (SMTs) as a treatment option for acute (<6 weeks) or chronic (>6 weeks) conditions of low back pain. The paper details how acute and chronic cases of low back pain can resolve via regression to the mean or by their natural history in many cases. According to the results, 3% of low back pain treatments for acute cases influenced pain level variance. Additionally, 32% of low back pain treatments could be attributed to treatment during chronic cases. Natural history is proven to be effective for certain diagnoses in physical therapy and appears to be an effective treatment of the acute low back. However, SMT does appear to be an effective treatment for chronic low back pain cases. It is hard to quantify the effectiveness of SMT when the therapeutic mechanism is ambiguous. However, we must not mistake ambiguity for ineffectiveness. SMTs do have a place in the therapist’s toolbox as an effective pain modulator, further research is needed to assess the value of the treatment as a first line of defense when treating patients experiencing pain.

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 doesn’t provide enough inclusion criteria information in the methods section for me to recognize the legitimacy of the meta-analysis. The paper details how the inclusion criteria took spinal manipulative therapy (SMT) literature from 26 years and classified them into 5 groups: SMT, exercise, physiotherapy modalities, usual medical care, and control groups. A sixth category was separated from the SMT group as whole system case management. Unfortunately, these are all the inclusion criteria given, leaving room for biased studies to enter the pool of data. Due to ambiguous inclusion criteria, we must heavily question the findings of this paper. The paper highlights the strength of natural history and regression to the mean as treatment options for low back pain. Clinically, I think educating patients on this phenomenon has value. Low back pain can be frightening, and educating patients on their condition and their ability to get better without treatment can be valuable. Additionally, this paper supports SMTs in chronic low back pain patients. I believe SMTs can be therapeutic for adequate candidates, and this paper supports that notion. Therapists could potentially use SMTs for pain modulation throughout the continuum of care provided to chronic patients. However, therapists must not confuse the effects of SMTs with the underlying effectiveness of natural history.

Author Names

Rubinstein, S. M., Terwee, C. B., Assendelft, W. J., de Boer, M. R., & van Tulder, M. W.

Reviewer Name

Nikol Papa, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

This review seeks to study the effects of SMT for acute low‐back pain. SMT in this case includes both spinal mobilization and manipulation. Many systematic reviews have been conducted appraising the efficacy of SMT on LBP; however, few have been directed at acute LBP specifically, with even fewer still being meta analyses. This current review seeks to update the previous Cochrane review on SMT for acute LBP for three main reasons. One, previous estimates on the usefulness of SMT were based on smaller studies with a high risk of bias. Two, several RCTs have been conducted since the 2004 review which follow updated methodology for carrying out systemetic reviews, new criteteria for assessing risk of bias, and evaluating the strength of evidence. Three, this review follows the most recent guidelines released by both the Cochrane Collaboration and the Cochrane Back Review Group.

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

2. Were eligibility criteria for included and excluded studies predefined and specified?

• Yes

3. Did the literature search strategy use a comprehensive, systematic approach?

• Yes

4. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• Yes

5. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• Yes

6. Were the included studies listed along with important characteristics and results of each study?

• Yes

7. Was publication bias assessed?

• Yes

8. Was heterogeneity assessed? (This question applies only to meta-analyses.)

• Yes

Key Finding #1

SMT appears to be no better than other existing therapies for pain reduction and improvement of functional status

Key Finding #2

The decision to refer for SMT should be based upon costs, preferences of the patient and providers, and relative safety of the various treatment options

Please provide your summary of the paper

The authors did not find evidence to support the use of SMT on acute LBP similar to the previously released cochrane review. However, the findings rest more in the realm of inconclusivity due to the fact that two thirds of the included studies had a high risk of bias. The task the researchers set for themselves is inherently difficult as individuals with acute LBP have much better odds of their pain resolving on its own compared to chronic low back pain. Additionally, it is hard to catch significant differences in margins of change that are so small considering individuals with acute LBP are more likely to be close to their baseline status. In other words, SMT may be helpful when working with acute LBP patients, but the question is whether or not this intervention actually adds anything to the recovery trajectory patients with acute LBP are most likely going to follow anyway.

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

Most of the studies in this review had a high risk of bias but there were a couple of studies that had small to moderate findings in support of using SMT for treating acute LBP. The article itself mentioned, while the findings are inconclusive at best, there are still clinicians that utilize SMT for acute LBP and note positive outcomes and increased functional ability in their patients. Clinicians reading this article should continue to do their best to stay up to date on the development of outcomes related to using this intervention but also must not discredit their clinical experience and clinical judgement when working with patients that have acute LBP.

Author Names

Namnaqani FI, Mashabi AS, Yaseen KM, Alshehri MA

Reviewer Name

Angelo Pata SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

The aim of this study was to evaluate the effectiveness of the McKenzie method compared to manual therapy in the management of patients with chronic low back pain (CLBP). Randomised controlled trials evaluating the McKenzie method in treating CLBP in adults compared to manual therapy (MT) were searched in MEDLINE, CINAHL, Cochrane Library, and PEDro. The primary outcomes were pain and disability. Five trials were eligible for inclusion in the review, of which, most had a score of 8 out of 11 on the PEDro scale. At 2-3 months, all studies reported significant improvement in the pain level in the McKenzie group, and more than that in the MT group. At 6 months, significant improvements had occurred in the disability index reported by two trials in the McKenzie group than the MT group. At 12 months follow-up, there were no significant differences in measures of LBP, but three studies reported that the McKenzie method group had a better disability level than the MT group. In patients with CLBP, many pain measures showed that the McKenzie method is a successful treatment to decrease pain in the short term, while the disability measures determined that the McKenzie method is better in enhancing function in the long term.

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

2. Were eligibility criteria for included and excluded studies predefined and specified?

• Yes

3. Did the literature search strategy use a comprehensive, systematic approach?

• Yes

4. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias?

• Yes

5. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity?

• Yes

6. Were the included studies listed along with important characteristics and results of each study?

• Yes

7. Was publication bias assessed?

• Yes

8. Was heterogeneity assessed? (This question applies only to meta-analyses.)

• Cannot Determine, Not Reported, Not Applicable

Key Finding #1

In the short term (2-3 months), the McKenzie method was more effective than Manual therapy in terms of pain level in patients with chronic low back pain.

Key Finding #2

In the long term (6 months), the McKenzie method showed better disability index scores than manual therapy for patients with chronic low back pain.

Key Finding #3

The McKenzie method was shown to be superior in this study to manual therapy when treating patients with low back pain. However, both treatment methods were shown to be effective.

Please provide your summary of the paper

This study used randomized control trials (RCTs) to compare the effectiveness of the McKenzie method versus manual therapy when treating patients with chronic low back pain (CLBP). The study utilized qualitative and quantitative methods from The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to perform data analysis. It was found that the McKenzie method and manual therapy were both effective treatment strategies for patients with CLBP. However, in the short term (2-3 months) the McKenzie method was found to have greater decreases in patient pain. Also, compared to manual therapy, the McKenzie method showed improved disability scores in the long term for patients with CLBP.

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

If the goal is to decrease pain in the short term, and improve function in the long term, the McKenzie method would be the preferred choice over manual therapy when treating a patient with CLBP. However, it is critical to keep in mind that manual therapy is also an effective modality for treating CLBP. Clinically, this research indicates utilization of the McKenzie method over manual therapy for a patient with CLBP. However, as clinicians, it is vital to keep in mind that not all methods of treatment shown to be superior through research will be the most effective choice for every patient. Trying the McKenzie method first may be a suitable choice. If the method does not produce the desired results, moving to another validated method like manual therapy would be indicated to treat patients with CLBP.