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Osteopathic manipulation treatment versus therapeutic exercises in patients with chronic nonspecific low back pain: A randomized, controlled and double-blind study

Author Names

Oliveira Meirelles, F. , Oliveira Muniz Cunha, J.C., Silva, E.B.

Reviewer Name

Allison Hinish, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

BACKGROUND: Osteopathic manipulation treatment is widely used in the clinical practice in the care of patients with chronic nonspecific low back pain, however, its benefits still seem uncertain.

OBJECTIVE: This study aimed to verify the efficacy of osteopathic manipulation for chronic nonspecific low back pain.

MATERIALS AND METHODS: Forty-two participants with chronic nonspecific low back pain were selected and randomized into two groups: active control group (ACG – n = 19) and osteopathic manipulation treatment group (OMTG – n = 23). Therapeutic exercises were performed with the ACG and osteopathic manipulation techniques with the OMTG. The interventions were carried out over 5 weeks of treatment, totaling 10 treatments for the ACG and 5 for the OMTG. The visual analogue scale (VAS) was used to measure chronic nonspecific low back pain and the Oswestry Disability Index 2.0, Tampa Scale of Kinesiophobia and Beck Depression Inventory were used to measure disability, kinesiophobia and depression, respectively.

RESULTS: The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p 6 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p = 0.001).

CONCLUSION: This study demonstrated that the treatments were effective in both groups. However, the efficacy of the osteopathic manipulation treatment was greater than that of the therapeutic exercises. Keywords: Osteopathy, osteopathic manipulation treatment, chronic nonspecific 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?

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

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

Were study participants and providers blinded to treatment group assignment?

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

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

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

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?

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

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

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?

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

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

Both groups had statistically significant improvement in pain rating and functional capacity after treatment, measured by the Visual Analogue Scale and Owestry Disability Index. Two way repeated measures ANOVA and post-hoc analysis found the Osteopathic Manipulation Treatment group had significantly greater improvement in these measures compared to the active control group.

Key Finding #2

Two-way repeated measures ANOVA and post-hoc analysis of both groups showed no significant improvement in scores for depression or kinesiophobia in either group after treatment.

Please provide your summary of the paper

This double-blind randomized controlled sough to examine whether therapeutic exercise based treatment or osteopathic manipulation treatment was better for treating patients with chronic nonspecific low back pain. Study participants 30 to 50 years old with chronic low back pain (greater than 3 months duration) with an intensity rating above 30 mm on the Visual Analogue Scale were randomized into either the active control group (ACG) or osteopathic manipulation treatment group (OMTG). Individuals with low back pain caused by fractures or dislocations of the spine, ligament ruptures, muscle ruptures, skin lacerations, sacroiliitis, vertebral osteomyelitis, infections, disc herniation with radicular symptoms, rheumatic disorders, cauda equina syndrome, tumors, visceral referred pain, red flags, or lower limb discrepancy greater than 20 mm were excluded from the study. After a pre-intervention assessment, the ACG group was given 2 sessions per week for 5 weeks, for a total of 10 treatment sessions. The ACG treatment was provided by physical therapy students with supervision from an experienced physical therapist. The OMTG group underwent 1 treatment session per week for 5 weeks for a total of 5 sessions, provided by a physical therapist with a graduate degree in Osteopathy. 4 variables were assessed: pain, functional level, kinesiophobia, and depression. These were measured pre and post treatment using the Visual Analogue Scale, Owestry Disability Index, Tampa Scale of Kinesiophobia, and Beck Depression Inventory, respectively. Results from these measurements were analyzed using a two-way repeated measures ANOVA and post-hoc analysis. Statistical analysis found that both the ACG and OMTG had significant improvement in functional capacity and pain levels after treatment, but the OMTG had significantly greater improvement than the ACG. While both groups demonstrated some improvement in kinesiophobia and depression levels, neither group had statistically significant results. The ultimate conclusion of this study determined osteopathic manipulation is more effective at treating chronic nonspecific low back pain than therapeutic exercise. There were some limitations to this study that may have influenced outcomes. The first is that treatment in the ACG group was being provided by student physical therapists, whereas the OMTG group was being treated by more skilled physical therapists with additional training. This difference in skill level may have influenced efficacy of treatment. Also, it was stated that treatment protocol in this study was very generalized and techniques used were not specified to only one body region, due to the nonspecific nature of the participants low back pain. More targeted or customized treatment methods in either group may have influenced results. Finally, specific details of what exercises and manipulation techniques were used in treatment were not readily accessible for review. Analysis of exercises treatment techniques would lend itself to be more useful for readers looking for successful treatment options.

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 overall was soundly conducted and the paper provided detailed descriptions of the study design, participant selection, group assignment, etc. The researchers made sure to properly design their study for reliable and internally valid results. The biggest fault lies in the difference in skill level of the physical therapists assigned to treat the therapeutic exercise group compared to the osteopathic manipulation group. While there was an experienced clinician present during the active control group treatment, the session was conducted by

student physical therapists. The lack of experience in treatment may have led to less valid results than if an experienced and skilled clinician was providing therapeutic exercise, like in the osteopathic manipulation group. Despite this fact, the study does demonstrate that osteopathic manipulation produces strong improvements in patients’ perceived pain levels and functional levels. While the results can only be applied to patient with nonspecific low back pain with no known origin, it is still helpful to know that manipulation can be effective for this large patient population. The study also demonstrated that therapeutic exercise alone leads to significant improvements in pain levels and functional ability. This suggests that the therapeutic exercise and osteopathic manipulation when used together could compound to create even greater improvements than either treatment alone. These findings could be used as the basis for future research on combining the two approaches.

Effect of Lumbar Spine Manipulation on Asymptomatic Cyclist Sprint Performance and Hip Flexibility

Author Names

Olson, E., Bodziony, M., Ward, J., Coats, J., Koby, B. Goehry, D.

Reviewer Name

Tyler Grissom, SPT

Reviewer Affiliation(s)

Duke DPT Student

Paper Abstract

Objective The purpose of this study was to measure the impact of midlumbar spinal manipulation on asymptomatic cyclist sprint performance and hip flexibility. Methods Twelve cyclists were equally randomized into an AB:BA crossover study design after baseline testing. Six participants were in the AB group, and 6 were in the BA group. The study involved 1 week of rest in between each of the 3 tested conditions: baseline testing (no intervention prior to testing), condition A (bilateral midlumbar spine manipulation prior to testing), and condition B (sham acupuncture prior to testing, as a control). Testing was blinded and involved a sit-and-reach test followed by a 0.5-km cycle ergometer sprint test against 4-kp resistance. Outcome measures were sit-and-reach distance, time to complete 0.5 km, maximum heart rate, and rating of perceived exertion. An additional 8 cyclists were recruited and used as a second set of controls that engaged in 3 testing sessions without any intervention to track test acclimation. An analysis of variance was used to compare dependent variables under each of the 3 conditions for the experimental group and control group #1, and a repeated-measures analysis of variance was used to analyze test acclimation in control group #2. Results Lumbar spine manipulation did not demonstrate statistically significant between-group changes in sit-and-reach (P = .765), 0.5-km sprint performance time (P = .877), maximum exercise heart rate (P = .944), or rating of perceived exertion (P = .875). Conclusions The findings of this preliminary study showed that midlumbar spinal manipulation did not improve hip flexibility or cyclist power output of asymptomatic participants compared with an acupuncture sham and no-treatment control groups.

NIH Risk of Bias Tool

Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies

Was the research question or objective in this paper clearly stated?

Was the study population clearly specified and defined?

Was the participation rate of eligible persons at least 50%?

Were all the subjects selected or recruited from the same or similar populations (including the same time period)? Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants?

Was a sample size justification, power description, or variance and effect estimates provided?

For the analyses in this paper, were the exposure(s) of interest measured prior to the outcome(s) being measured?

Was the timeframe sufficient so that one could reasonably expect to see an association between exposure and outcome if it existed?

For exposures that can vary in amount or level, did the study examine different levels of the exposure as related to the outcome (e.g., categories of exposure, or exposure measured as continuous variable)?

Were the exposure measures (independent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?

Was the exposure(s) assessed more than once over time?

Were the outcome measures (dependent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?

Were the outcome assessors blinded to the exposure status of participants?

Was loss to follow-up after baseline 20% or less?

Were key potential confounding variables measured and adjusted statistically for their impact on the relationship between exposure(s) and outcome(s)?

Key Finding #1

Lumbar spine manipulation did not demonstrate a statistically significant difference in sit and reach.

Key Finding #2

Lumbar spine manipulation did not demonstrate a statistically significant difference in sprint performance time.

Key Finding #3

Lumbar spine manipulation did not demonstrate a statistically significant in maximum exercise heart rate or perceived rate of exertion.

Key Finding #4

Lumbar spine manipulation did not improve hip flexibility or cyclist power output of asymptomatic participants compared with an acupuncture sham and no-treatment control groups.

Please provide your summary of the paper

Participants were placed into 3 different groups. There were 20 participants in total. Group 1 had 8 cyclists and this was the baseline condition where they received no intervention before testing. Group 2 had 6 cyclists who received bilateral lumbar spine manipulation before testing. Group 2 participants also rested in a chair for 15 minutes to match the duration of the acupuncture group. Group 3 had 6 cyclists received sham acupuncture before the intervention for 15 minutes. The cyclists were then tested on a standard sit and reach using a protocol and a cycle ergometer against 4-kp resistance using a protocol. The outcome measures that were collected were sit-and-reach distance, time to complete 0.5km, maximum heart rate, and rating of perceived exertion. There was a one-week period of recovery in between testing. The results of the study were that spinal manipulation did not improve hip flexibility or cyclist power output compared to acupuncture sham and the no-treatment control group.

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

Spinal manipulation has been used in athletes to improve athletic performance. For example, one study performed by Costa et al, found that golfers who received spinal manipulation were able to hit the ball farther. This could be due to tissue or muscle stretching and the ligament can recoil more thus generating more force and power during the rotation of a swing. However, the evidence of spinal manipulation increasing athletic performance requires more research to draw conclusive results. In clinical practice when working with specifically rotational athletes such as baseball pitchers, golfers, and baseball hitters; spinal manipulation may be an intervention to use to help the muscles generate more force to be able to improve performance.

Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy on Pain and Disability for Patients with Chronic Low Back Pain: a Randomized Controlled Trial

Author Names

Tavares, F., Rossiter, J., Lima, G., Oliveira, L., Cavalcante, W., Ávila, M., George, S., Chaves, T.

Reviewer Name

Elise Giannotti, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: Spinal manipulative therapy (SMT) demonstrates small effects on pain intensity in low back pain. Combining SMT with a psychosocial intervention like pain neuroscience education (PNE) could promote additional effect. Objectives: To evaluate the additional effect of PNE when combined to SMT on pain intensity and low back pain-related disability in patients with chronic low back pain (CLBP). Method: One hundred and four patients with CLBP of both sexes aged between 18 and 55 years were treated with PNE + SMT compared to SMT alone. The primary outcome measures were pain intensity and disability post-treatment (4 weeks). Secondary outcomes were fear-avoidance beliefs, global perceived effect of improvement, and pain self-efficacy. Results were obtained immediately post-treatment and at three follow-ups (30-days, 90-days, and 180-days). Results: No significant between-group difference was observed for pain intensity and disability post-treatment. In contrast, our results showed a significantly longer additional effect for the group treated with SMT + PNE for the following outcomes: pain intensity (change baseline to 90 day follow-up = 0.90 [95% CI= 1.76, 0.4] and change baseline to 180 day follow-up = 1.19 [95% CI= 2.06, 0.32]) and low back pain-related disability, global perceived effect of improvement and pain self-efficacy (180th day follow-up). Conclusion: The results of this trial suggest the addition of PNE to SMT did not bring any additional effect on pain intensity and disability in the short term, but SMT + PNE can result in longer-lasting effects in patients with CLBP and that such an effect could be related to a possible mediator effect of pain self-efficacy.

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

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

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

Were study participants and providers blinded to treatment group assignment?

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

Cannot Determine, Not Reported, or Not Applicable

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

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

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

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

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

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

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?

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

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

There was no significant difference between subjects receiving only spinal manipulative therapy (SMT) and subjects receiving both pain neuroscience education (PNE) and SMT at the immediate post-treatment assessment.

Key Finding #2

At the 90day and 180day assessments, those subjects that received both PNE and SMT were found to have lower pain intensity ratings on NPRS, lower scores on the ODI describing their low back pain-related disability, and better pain self-efficacy scores on the questionnaire. PNE may be effective for long-term results.

Key Finding #3

Based on this design, the subjects only received PNE for the first two sessions out of eight sessions. The PNE consisted of two thorough, 40minute sessions with powerpoints, discussions, and animated videos. One may be able to conclude that education in relatively small, yet thorough amounts is also effective for the long-term success of a patient.

Please provide your summary of the paper

This study performed a randomized controlled trial to determine whether the addition of pain neuroscience education (PNE) would be beneficial to those who experience chronic low back pain (CLBP). By including this psychosocial aspect to their intervention, researchers hypothesized the group receiving PNE + spinal manipulative therapy (SMT) would see greater reduction in both pain intensity and LBP disability reports. Immediate post-treatment assessments did not support their hypothesis, instead it found there was no significant difference between the group who received PNE + SMT and the group who only received SMT. Pushing forward, researchers collected data at the 90day mark and the 180day mark. There, they found significant differences. The PNE + SMT group showed long term impact through just two sessions of PNE at the start of the study. This study concluded long term effects of the psychosocial intervention positively affects the quality of life of those experiencing CLBP.

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 translates easily into practice by recognizing some patients with CLBP will have long-term success if physical therapists can provide education on pain neuroscience. Knowing that in this study the PNE + SMT group only received PNE in the first two sessions and followed with only SMT for the next six sessions, it is possible to see long term effects with relatively small, yet thorough amounts of education. Bringing that concept to clinical practice, we may be able to help patients the most by guiding them to understand their pain: why it occurs, what it really tells us, and what biologically happens to make pain emerge. Based on this research, by educating our patients on pain science, we can help them see success in their future.

Spinal Manipulative Therapy for Nonspecific Low Back Pain: Does Targeting a Specific Vertebral Level Make a Difference?: A Systematic Review With Meta-analysis

Author Names

Sørensen, P. W., Nim, C. G., Poulsen, E., & Juhl, C. B.

Reviewer Name

Catherine Gardner, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Abstract OBJECTIVE: We aimed to examine whether targeting spinal manipulative therapy (SMT), by applying the intervention to a specific vertebral level, produces superior clinical outcomes than a nontargeted approach in patients with nonspecific low back pain. DESIGN: Systematic review with meta-analysis. LITERATURE SEARCH: MEDLINE, Embase, CENTRAL, CINAHL, Scopus, PEDro, and Index to Chiropractic Literature were searched up to May 31, 2023. STUDY SELECTION CRITERIA: Randomized controlled trials comparing targeted SMT (mobilization or manipulation) to a nontargeted approach in patients with nonspecific low back pain, and measuring the effects on pain intensity and patient-reported disability. DATA SYNTHESIS: Data extraction, risk of bias, and evaluation of the overall certainty of evidence using the GRADE approach were performed by 2 authors independently. Meta-analyses were performed using the restricted maximum likelihood method. RESULTS: Ten randomized controlled trials (n = 931 patients) were included. There was moderate-certainty evidence of no difference between targeted SMT and a nontargeted approach for pain intensity at postintervention (weighted mean difference = −0.20 [95% CI: −0.51, 0.10]) and at follow-up (weighted mean difference = 0.05 [95% CI: −0.26, 0.36]). For patient-reported disability, there was moderate-certainty evidence of no difference at postintervention (standardized mean difference = −0.04 [95% CI: −0.36, 0.29]) and at follow-up (standardized mean difference = −0.05 [95% CI: −0.24, 0.13]). Adverse events were reported in 4 trials, and were minor and evenly distributed between groups. CONCLUSION: Targeting a specific vertebral level when administering SMT for patients with nonspecific low back pain did not result in improved outcomes on pain intensity and patient-reported disability compared to a nontargeted approach.

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?

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

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

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

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

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

Was publication bias assessed?

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

Key Finding #1

There is no difference between targeting and not targeting a specific vertebral level for spinal manipulative therapy (SMT).

Key Finding #2

There was no difference in the change in pain intensity, disability, or adverse events post-intervention between non-targeted and targeted spinal manipulative therapy.

Key Finding #3

New high-quality studies have the possibility to change these results.

Please provide your summary of the paper

The primary goal of this review was the investigate if there is a difference between targeting or not targeting specific vertebral levels for spinal manipulative therapy. This review looked at 10 studies between 1998 to 2020 specifically looking at adults with non-specific low back pain with or without leg pain. They did not look at the differences between grades of spinal manipulative therapy. The two primary outcome measures being studied were patient-reported pain intensity and self-reported disability, which were both assessed post-intervention and again around a 12-month follow-up. Adverse events were also assessed, which included muscle soreness, aggregation of pain, or stiffness lasting less than 48 hours. The review with meta-analysis showed with moderate certainty evidence that there is no difference in changes in pain intensity, disability, or adverse events between groups of patients with low back pain who received either targeted or nontargeted spinal manipulative therapy.

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

This recent study (Sep. 2023) will impact clinical practice specifically because it contradicts previously written textbooks and educational material. Historically, students have been taught to palpate a patient’s specific vertebral level to target the intervention and how important it was to find the most appropriate vertebrae. With the results of this review and the included studies, it is clear that this is an outdated concept. As a result, educational materials such as textbooks, lecture materials, and continuing education courses should be updated to reflect the most recent and supported knowledge.

Short-Term Effects of Manual Therapy plus Capacitive and Resistive Electric Transfer Therapy in Individuals with Chronic Non-Specific Low Back Pain: A Randomized Clinical Trial Study

Author Names

Kasimis, K., Iakovidis, P., Lytras, D., Koutras, G., Chatziprodromidou, I. P., Fetlis, A., Ntinou, S. R., Keklikoglou, N. M., Samiotaki, A., Chasapis, G., Tarfali, G., & Apostolou, T.

Reviewer Name

Joshua Copeland, SPT

Reviewer Affiliation(s)

Duke University School of Medicine Doctor of Physical Therapy Division

Paper Abstract

Background and Objectives: Chronic non-specific low back pain (CNSLBP) is defined as back pain that lasts longer than 12 weeks. Capacitive and resistive electric transfer (TECAR) therapy utilizes radiant energy to generate endogenous heat and is widely used for the treatment of chronic musculoskeletal pain. The aim of this study was to investigate the efficacy of manual therapy (MT) program combined with TECAR therapy in individuals with CNSLBP. Materials and Methods: Sixty adults with CNSLBP were randomly divided equally into three groups. The first group followed an MT protocol in the lumbar region (MT group), the second group followed the same MT protocol combined with TECAR therapy (MT + TECAR group) using a conventional capacitive electrode as well as a special resistive electrode bracelet, and the third group (control group) received no treatment. Both intervention programs included six treatments over two weeks. Pain in the last 24 h with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland–Morris Disability Questionnaire (RMDQ), pressure pain threshold (PPT) in the lumbar region with pressure algometry, and mobility of the lumbo-pelvic region through fingertip-to-floor distance (FFD) test were evaluated before and after the intervention period with a one-month follow-up. Analysis of variance with repeated measures was applied. Results: In the NPRS score, both intervention groups showed statistically significant differences compared to the control group both during the second week and the one-month follow-up (p < 0.001). Between-group differences were also noticed between the two intervention groups in the second week (p < 0.05). Differences in the RMDQ score were detected between the intervention groups and the control group in the second week and at the one-month follow-up (p < 0.001), while differences between the two intervention groups were only detected at the one-month follow-up (p < 0.001). Regarding the PPT values, differences were found mainly between the MT + TECAR group and the control group and between the MT + TECAR group and the MT group (p < 0.05), with the MT + TECAR group in most cases showing the greatest improvement compared to the other two groups, which remained statistically significant at the one-month follow-up (p < 0.05). Finally, both intervention groups improved the mobility of the lumbo-pelvic region at both time points compared to the control group without, however, statistically significant differences between them (p > 0.05). Conclusions: The application of an MT protocol with TECAR therapy appeared more effective than conventional MT as well as compared to the control group in reducing pain and disability and improving PPT in individuals with CNSLBP. No further improvement was noted in the mobility of the lumbo-pelvic region by adding TECAR to the MT intervention.

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

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

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

Were study participants and providers blinded to treatment group assignment?

Cannot Determine, Not Reported, or Not Applicable

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

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

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

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

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

Cannot Determine, Not Reported, or Not Applicable

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?

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?

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

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

Applying the same manual therapy techniques using capacitive and a resistive electrode bracelet demonstrated improved pain rating outcomes which were maintained one month following treatment when compared to just manual therapy and no treatment.

Key Finding #2

Improvements were observed in pressure pain threshold for both the sacroiliac joint and L4-L5 paraspinal intervertebral space.

Key Finding #3

Manual therapy using capacitive and a resistive electrode bracelet resulted in no significant difference in the quadratus lumborum musculature when compared to just manual therapy.

Key Finding #4

Improved fingertip-to-floor test for both intervention groups (MT and MT + TECAR) in the second week and maintained for one month follow-up when compared to the control group.

Please provide your summary of the paper

This randomized clinical trial examined the efficacy of manual therapy combined with capacitive and resistive electric transfer (TECAR) therapy for individuals with chronic non-specific low back pain to just manual therapy and no treatment. Chronic non-specific low back pain, as defined in the study, is any low back pain that lasts longer than 12 weeks and TECAR therapy is a therapeutic technique that uses electrical current with medium frequency to trigger physiological processes in the underlying tissue. The results showed that manual therapy can be beneficial when coupled up with TECAR therapy to improve pain rating outcomes in patients. Similarly, improvements were made in pressure pain threshold following treatment for both the sacroiliac joint and L4-L5 paraspinal intervertebral space. Even though there were improvements in the MT+TECAR group in relation to pain, this study does consist of a small sample size of participants and a small time frame in which data was collected. TECAR therapy is a widely accepted intervention used in physical therapy but not much research has been completed analyzing its effectiveness on soft tissue. There is low reliability on the fingertip-to-floor outcome measure due to other variables such as sacroiliac dysfunction or hamstring tightness. While there is further research to be conducted in the near future, it appears that manual therapy can be beneficial for chronic non-specific low back pain, especially when combined with capacitive and resistive electric transfer therapy.

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

This study demonstrates that manual therapy combined with other modalities may improve outcomes for specific musculoskeletal conditions. Further research is needed to determine the long-term effects of using manual therapy combined with another modality, such as TECAR therapy, to determine its impact on long-term pain management. However, this study does demonstrate that manual therapy can be combined with TECAR therapy to help improve pressure pain threshold, improvements in L4-L5 paraspinal intervertebral space and sacroiliac joint for short-term pain relief. In order to improve long-term pain relief, manual therapy and TECAR therapy shouldn’t be the only intervention implemented for all therapeutic sessions. Instead, using manual therapy and TECAR therapy can be used adjacent to an individualized strength training program.

Effectiveness of a Manual Therapy Protocol in Women with Pelvic Pain Due to Endometriosis: A Randomized Clinical Trial

Author Names

Munoz-Gomez, Elena. et al

Reviewer Name

Kayla Contreras, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Program

Paper Abstract

A randomized controlled trial was carried out to assess the effectiveness of a manual therapy protocol in terms of the clinical characteristics, quality of life, and emotional condition of the women with endometriosis-related pelvic pain. Forty-one women (mean age of 36.10 (6.97) years) with pelvic pain due to endometriosis were randomly divided into (i) a manual therapy group (MTG) (n = 21) and (ii) a placebo group (PG) (n = 20). Both groups received an 8-week intervention. Pain, lumbar mobility, endometriosis health profile, quality of life, depression and anxiety levels, and the patient’s perception of change were assessed before (T0) and after (T1) the intervention, as well as at a one-month follow-up (T2) and a six-month follow-up (T3). The MTG significantly improved pain intensity, powerlessness, lumbar mobility, and physical quality of life at T1 (p < 0.05). The results were maintained for pain intensity at T2 and T3. In addition, both the MTG and PG improved emotional wellbeing at T1 (p < 0.05). Neither group improved in terms of social support, self-image, and depression and anxiety levels after the intervention (p > 0.05). In conclusion, manual therapy may be an excellent complement to the gynecological treatment of endometriosis-related pelvic pain by alleviating pain and improving women’s endometriosis health profile and physical quality of life.

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?

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

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

Cannot Determine, Not Reported, or Not Applicable

Were study participants and providers blinded to treatment group assignment?

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

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

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?

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

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

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?

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

Cannot Determine, Not Reported, or Not Applicable

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

Pain often persists after the treatment of endometriosis as nociplastic pain so finding alternative treatments to relieve the patient of pain is a difficult challenge.

Key Finding #2

Changes in pelvic pain were maintained after both the one and six-month follow-ups

Key Finding #3

Emotional well-being also improved after the placebo intervention likely due to the “hands-on” effect or feeling of being treated.

Please provide your summary of the paper

The results of the study showed that manual therapy can be a helpful treatment to women with endometriosis by improving pelvic pain, the endometriosis health profile, and physical quality of life. Chronic fatigue and pain-catastrophizing thoughts have been related to functional limitations in this population leading to deconditioning and a lack of musculoskeletal flexibility. Therefore by applying manual therapy to the lumbar region the MTG showed significant improvements in lumbar mobility compared to the PG. A limitation to this study however, is that it used manual therapy techniques for multiple regions of the spine (cervical, thoracic, lumbar) therefore the positive results of the study as a whole cannot be narrowed down to a single manual therapy technique unless measuring that single region. The results of the MTG and PG showed that the use of manual therapy is a valuable tool to use when treating pelvic pain due to endometriosis, but does not show effects for the emotional status of the patients (anxiety and depression). In the future, combining the use of manual therapy as well as treatments to tackle the mental side effects of endometriosis (yoga, breathing strategies, cognitive therapy) would be a successful way to treat future patients.

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

I think this study showed that even after the treatment of the a patient’s diagnosis, they may still experience pain. It is up to the clinician and their healthcare team to provide the patient with the resources and connections to treat their pain as much to our ability. The findings of this study can impact clinical practice by referring patients with endometriosis or other pelvic pathologies to physical therapy to see if manual therapy may benefit them. It also reminded me that we have to treat our patients holistically as well. If manual therapy is treating the patient’s physical symptoms but they are still showing mental health symptoms I could refer them to a cognitive therapist or discuss breathing treatments, yoga, or other calming exercises they could use. I will implement these results by keeping my mind open to all treatment approaches and by also trying manual therapy with patients if I feel that it could benefit them and increase their functional mobility.

The effect of manual therapy and neuroplasticity education on chronic low back pain: a randomized clinical trial

Author Names

Louwa, A; Farrellb, K; Landersc, M; Barclayb, M; Goodmanb, E; Gillundb, J; McCaffrey, S; Timmerman, L

Reviewer Name

Elizabeth Carey, SPT

Reviewer Affiliation(s)

Duke University, Doctor of Physical Therapy Division

Paper Abstract

Objective: To determine if a neuroplasticity educational explanation for a manual therapy technique will produce a different outcome compared to a traditional mechanical explanation. Methods: Sixty-two patients with chronic low back pain (CLBP) were recruited for the study. Following consent, demographic data were obtained as well as pain ratings for low back pain (LBP) and leg pain (Numeric Pain Rating Scale), disability (Oswestry Disability Index), fear avoidance (Fear-Avoidance-Beliefs Questionnaire), forward flexion (fingertips-to-floor), and straight leg raise (SLR) (inclinometer). Patients were then randomly allocated to receive one of two explanations (neuroplasticity or mechanical), a manual therapy technique to their lumbar spine, followed by post-intervention measurements of LBP, leg pain, forward flexion, and SLR. Results: Sixty-two patients (female 35 [56.5%]), with a mean age of 60.1 years and mean duration of 9.26 years of CLBP participated in the study. There were no statistically significant interactions for LBP (p = .325), leg pain (p = .172), and trunk flexion (p = .818) between the groups, but SLR showed a significant difference in favor of the neuroplasticity explanation (p = .041). Additionally, the neuroplasticity group were 7.2 times (95% confidence interval = 1.8–28.6) more likely to improve beyond the MDC on the SLR than participants in the mechanical group. Discussion: The results of this study show that a neuroplasticity explanation, compared to a traditional biomechanical explanation, resulted in a measurable difference in SLR in patients with CLBP when receiving manual therapy. Future studies need to explore if the increase in SLR correlated to changes in cortical maps of the low back.

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

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

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

Were study participants and providers blinded to treatment group assignment?

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

Cannot Determine, Not Reported, or Not Applicable

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

Cannot Determine, Not Reported, or Not Applicable

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

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

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

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

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

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)?

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

Explaining treatment techniques and goals to patients using neuroplasticity principles can result in measurable improvements compared to patients receiving biomechanical explanations.

Key Finding #2

When in conjunction with manual therapy, neuroplasticity education improves the straight leg raise test scores for patients with chronic low back pain when compared to similar patients who receive biomechanical education.

Key Finding #3

There was no difference indicated between the test and control group’s responses to education and treatment in low back pain rating, leg pain, and forward flexion.

Key Finding #4

Although the straight leg raise exceeded the MCD with neuroplastic education, there is no MCID for the SLR test. Therefore, it is unknown if the change is clinically meaningful.

Please provide your summary of the paper

The goal of this randomized clinical trial was to compare the effects of manual therapy along with a biomechanical explanation (control group) or a neuroplasticity explanation (experimental group) on low back pain, leg pain, forward flexion, and a straight leg raise. 62 patients with chronic low back pain participated in the study, and provided initial ratings for low back pain, leg pain, disability, fear avoidance, forward flexion, and straight leg raise. All patients received grade 2 central posterior-anterior mobilizations while in prone for 10 minutes. Half of the participants received an explanation of the manual therapy technique in biomedical terms (here is a picture of your low back, when you move, some of these segments stiffen up, I’m going to use my hands to make each level move,” etc.) while the other half in neuroplasticity terms (Here’s a picture of your brain where there’s a map telling you where your body parts are, moving less makes these parts of the brain work less and become blurry which can cause pain, I’m going to do some manual techniques on your back to help your brain sharpen these maps, etc.). Post-intervention, the same outcome measures were taken again. There was no significance between groups for low back pain leg pain, and trunk flexion, but the straight leg raise showed significant improvement for the neuroplasticity group. For the SLR, the neuroplasticity group participants exceeded the MCD from pre-test and was 7.2 times more likely to improve beyond the MCD compared to the biomechanical explanation group. Further studies are needed to explore whether this increase in SLR scores correlated with cortical map changes of the low back, and long-term effects of neuroplasticity education.

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 this clinical trial, I believe that principles of neuroplasticity can be incorporated into patient education to increase the likelihood of better outcomes in patients. Especially for conditions like chronic low back pain, finding a adaptation to treatment with the possibility of improving outcomes should be highly considered and further investigated. Neither explanation would have been successful without the use of manual therapy on the lumbar spine. The specific benefit to the straight leg raise in this study could be related to the rapid response of neurodynamics, as has been seen in other studies on pain neuroscience education. Further research is needed to test the ability of longer-term education on other aspects of physical examination, especially when the fear of movement is a limitation in progress.

Potential mechanisms for lumbar spinal stiffness change following spinal manipulative therapy: a scoping review

Author Names

Jun, P., Pagé , I., Vette, A., and Kawchuk, G.

Reviewer Name

Erica Block, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Introduction In individuals having low back pain, the application of spinal manipulative therapy (SMT) has been shown to reduce spinal stiffness in those who report improvements in post-SMT disability. The underlying mechanism for this rapid change in stiffness is not understood presently. As clinicians and patients may benefit from a better understanding of this mechanism in terms of optimizing care delivery, the objective of this scoping review of current literature was to identify if potential mechanisms that explain this clinical response have been previously described or could be elucidated from existing data. Methods Three literature databases were systematically searched (MEDLINE, CINAHL, and PubMed). Our search terms included subject headings and keywords relevant to SMT, spinal stiffness, lumbar spine, and mechanism. Inclusion criteria for candidate studies were publication in English, quantification of lumbar spinal stiffness before and after SMT, and publication between January 2000 and June 2019. Results The search identified 1931 articles. Of these studies, 10 were included following the application of the inclusion criteria. From these articles, 7 themes were identified with respect to potential mechanisms described or derived from data: 1) change in muscle activity; 2) increase in mobility; 3) decrease in pain; 4) increase in pressure pain threshold; 5) change in spinal tissue behavior; 6) change in the central nervous system or reflex pathways; and 7) correction of a vertebral dysfunction. Conclusions This scoping review identified 7 themes put forward by authors to explain changes in spinal stiffness following SMT. Unfortunately, none of the studies provided data which would support the promotion of one theme over another. As a result, this review suggests a need to develop a theoretical framework to explain rapid biomechanical changes following SMT to guide and prioritize future investigations in this important clinical area.

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?

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

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

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

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

Cannot Determine, Not Reported, Not Applicable

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

There are many potential mechanisms that could cause SMT to reduce spinal stiffness, however there is more research needed to further understand those mechanisms.

Key Finding #2

There is not one mechanism that has more evidence for being the cause of reduced stiffness post-SMT over another.

Please provide your summary of the paper

This scoping review investigated the potential mechanisms of how spinal manipulative therapy (SMT) reduces spinal stiffness. The different treatments analyzed in these studies included spinal manipulation, PA glides, lumbopelvic spinal manipulation, and manipulations using devices with external frames. From the 1,931 articles that this review explored, they discovered seven themes that could be potential mechanisms: change in muscle activity, increase in mobility, decrease in pain, increase in pressure pain threshold, change in spinal tissue behavior, change in the central nervous system, and lastly, correction of a vertebral dysfunction. With all the articles and studies that were reviewed, there weren’t any themes that could be prioritized as more likely to be a mechanism over others. The overall conclusion of this review is that there is a need for more research to truly understand the mechanism behind the changes in low back stiffness after spinal manipulation. A limitation of the review is that there were a variety of interventions examined which could have an effect on patient outcomes and understanding of the potential mechanisms. There was also a lack of inter-practitioner reliability.

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

The information from this scoping review is important for physical therapists to understand because as patients with low back pain are evaluated and treated, they will each have different structures in need of improvement. Understanding the mechanisms of SMT will help physical therapists determine which patients are most appropriate for this type of treatment and which may not experience the most benefit from it. Continuing this research will assist physical therapists in being able to provide individualized and higher quality care to each of their patients.

Lumbar Thrust Manipulation and Exercise for the Treatment of Mechanical Low Back Pain in Adolescents: A Case Series

Author Names

Walston Z., Yake D.

Reviewer Name

Ellie Berman, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Study Design Case series. Background Low back pain (LBP) is an increasing problem in health care. The evidence for the use of spinal manipulative therapy to treat pediatric patients with LBP is minimal. The treatment of pediatrics with manual therapy, particularly spinal manipulation, is controversial within the medical community, primarily with respect to adverse events. The purpose of this case series was to illustrate the feasibility and safety of lumbar manipulation plus exercise in the adolescent population with mechanical LBP. Case Description Three patients-a 13-year-old adolescent girl, 15-year-old adolescent girl, and 13-year-old adolescent boy-were treated in an outpatient physical therapy setting for mechanical LBP. All 3 patients were assessed using a lumbar manipulation clinical prediction rule and treated with sidelying lumbar manipulation and exercise. Outcomes Patients were treated for a total of 10 to 14 visits over a course of 8 to 9 weeks. Pain (measured by a numeric pain-rating scale) and disability (measured by the modified Oswestry Disability Index) improved to 0/10 and 0%, respectively, in each patient. No adverse reactions to manipulation were reported. Discussion The results of this case series describe the use of lumbar thrust manipulation and exercise for the treatment of mechanical LBP in adolescents. The positive results indicate that lumbar manipulation may be a safe adjunct therapy. Further studies, including randomized controlled trials, are needed to determine effectiveness.

NIH Risk of Bias Tool

Quality Assessment Tool for Case Series Studies

Was the study question or objective clearly stated?

Was the study population clearly and fully described, including a case definition?

Were the cases consecutive?

Were the subjects comparable?

Was the intervention clearly described?

Were the outcome measures clearly defined, valid, reliable, and implemented consistently across all study participants?

Was the length of follow-up adequate?

Were the statistical methods well-described?

Cannot Determine, Not Recorded, Not Applicable

Were the results well-described?

Key Finding #1

Manual therapy and lumbar manipulation can be a safe and effective adjunct therapy to exercise for adolescents with mechanical low back pain.

Key Finding #2

Adolescents receiving lumbar manipulation in addition to exercise for the treatment of mechanical low back pain reported improvements in pain, mobility, and disability, demonstrated by the modified Oswestry Disability Index, the Visual Analog Scale, and the Fear-Avoidance Beliefs Questionnaire work subscale.

Key Finding #3

Clinical prediction rules set forth by Flynn et al., and Fritz et al., may have a place in the pediatric population for determination of lumbar manipulation as a safe and effective treatment, however further research is needed to assess the effectiveness outside of the originally studied population.

Please provide your summary of the paper

The purpose of this case series was to evaluate the safety and effectiveness of lumbar manipulation in addition to exercise for the treatment of low back pain in the pediatric population. This study included 3 adolescent patients aged 13-15 with mechanical low back pain. Outcome measures recorded at both the initial evaluation and discharge included the modified Oswestry Disability Index (mODI), the Visual Analog Scale (VAS), the Fear-Avoidance Beliefs Questionnaire work subscale (FABQ-W), and objective measurements included in the CPR developed by Flynn et al. The treatment included bilateral lumbar manipulation in sidelying at the start of each session followed by exercise tailored to patient’s directional preference. Once patients were able to complete exercises comfortably in all 3 planes of motion, combined movements were introduced. Exercises initially focused on endurance and motor learning and progressed to hypertrophy and return-to-sport training. A home exercise program was prescribed after the second visit as to adequately assess patient’s response to initial manipulations. Patients were discharged once they were able to complete multi-planar and sport-specific movements pain-free and with equal power bilaterally. All patients demonstrated improvements in pain and disability with scores of 0/10 and 0%, respectively, at discharge.

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

This case series resulted in improvements in subjective and objective measures for adolescents after treatment of mechanical low back pain with lumbar manipulation and exercise. While this case aimed to illustrate the effectiveness and safety of thrust manipulations for this population, the study design limits the external validity of the results, thus inhibiting the ability to generalize to greater populations and impact clinical practice. Due to the lack of research investigating the effectiveness of lumbar manipulation CPRs in the pediatric population, the outcome measures were held constant despite a lack of validity with this population. Further research is needed for use of validated pediatric outcome measures in replacement of the FABQ-W in order to better analyze the perceived disability of this population. Additionally, more research is needed within this population to better translate findings into clinical practice.

Assessment of a taping method combined with manual therapy as a treatment of non-specific chronic low back pain – a randomized controlled trial

Author Names

Schmidt, S., Wölfle, N., Schultz, C., Sielmann, D., Huber, R., and Walach, H.

Reviewer Name

Carly Andrake, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: Chronic low back pain is the most frequent medical problem and the condition with the most years lived with disability in Western countries. The objective of this study was to assess a new treatment, Medi-Taping, which aims at reducing complaints by treating pelvic obliquity with a combination of manual treatment of trigger points and kinesio taping in a pragmatic RCT with pilot character. Methods: One hundred ten patients were randomized at two study centers either to Medi-Taping or to a standard treatment consisting of patient education and physiotherapy as control. Treatment duration was 3 weeks. Measures were taken at baseline, end of treatment and at follow-up after 2 months. Main outcome criteria were low back pain measured with VAS, the Chronic Pain Grade Scale (CPGS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ). Results: Patients of both groups benefited from the treatment by medium to large effect sizes. All effects were pointing towards the intended direction. While Medi-Taping showed slightly better improvement rates, there were no significant differences for the primary endpoints between groups at the end of treatment (VAS: mean difference in change 0.38, 95-CI [- 0.45; 1.21] p = 0.10; ODQ 2.35 [- 0.77; 5.48] p = 0.14; CPGS – 0.19 [- 0.46; 0.08] p = 0.64) and at follow-up. Health-related quality of life was significantly higher (p = .004) in patients receiving Medi-Taping compared to controls. Conclusions: Medi-Taping, a purported way of correcting pelvic obliquity and chronic tension resulting from it, is a treatment modality similar in effectiveness to complex physiotherapy and patient education.

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?

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

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

Were study participants and providers blinded to treatment group assignment?

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

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

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

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

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

Cannot Determine, Not Reported, or Not Applicable

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?

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?

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

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

Quality of life improved significantly more in the Medi-Taping group with a small- to medium-sized effect

Key Finding #2

The finger-to-floor distance, which measures functionality, improved significantly more in the Medi-Taping group

Key Finding #3

Changes in pain score (VAS) and function (ODQ) did not improve significantly in the Medi-Taping group

Key Finding #4

Patients in both groups benefitted from treatment

Please provide your summary of the paper

This study looked at the effects of Medi-Taping combined with manual therapy in patients with chronic low back pain. Two groups were created randomly: the experimental group, which received Medi-Taping and manual therapy, and the control group, which received physiotherapy and patient education. This study found that both groups benefitted from the treatment they received, but the Medi-Taping group had slightly better outcomes regarding quality of life and functionality. The finger-to-floor distance showed to be the most sensitive outcome measure, which measures functionality and showed greater improvements in the Medi-Taping group.

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

This study is the first to look at the use of Medi-Taping combined with manual therapy and was designed based on educated guesses and clinical impressions. Additionally, the study could be considered unreliable due to an over-optimistic power calculation. The study only included two centers, which makes the results difficult to generalize. Overall, the Medi-Taping treatment modality seems to have similar results to a physical therapy and patient education program for those with chronic low back pain. Further research should be done with a less over-optimistic powered study.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study

Author Names

Hensel, K; Buchanan, S; Brown, S; Rodriguez, M; Cruser, des Anges

Reviewer Name

Hannah Adkins, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective: The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery. Study design: Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were assigned randomly to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included 7 treatments over 9 weeks. The OMT protocol included specific techniques that were administered by board-certified OMT specialists. Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes. Results: There were 136 women in the OMT group: 131 women in the PUT group and 133 women in the UCO group. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back-related functioning (P < .001 for both groups), with outcomes for the OMT group similar to that of the PUT group; however, both groups were significantly improved compared with the UCO group. For secondary outcome of meconium-stained amniotic fluid, there were no differences among the groups. Conclusion: OMT was effective for mitigating pain and functional deterioration compared with UCO; however, OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high-risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during the third trimester.

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?

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

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

Were study participants and providers blinded to treatment group assignment?

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

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

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

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

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

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

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

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?

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

Cannot Determine, Not Reported, or Not Applicable

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

Osteopathic manipulative treatment (OMT) was more effective at reducing and managing low back pain while maintaining function in patients who are pregnant than usual care only (UCO).

Key Finding #2

OMT is a safe and effective modality to help women in their third trimester manage low back pain.

Key Finding #3

No significant differences in outcomes were found between the OMT and placebo ultrasound treatment (PUT) groups.

Please provide your summary of the paper

Low back pain is seen in almost 70% of pregnant patients, and management can be difficult because most pain medications are not safe to consume during pregnancy. This study looked at 3 different treatment methods to see if manual therapy was safe and effective in helping to manage pregnant patients’ low back pain. The participants were randomly assigned to 3 different groups, including usual care only (UCO), usual care with osteopathic manipulation treatment (OMT), and usual care with placebo ultrasound treatments (PUT). The study proved through self-report questionnaires that the OMT group was effective and safe compared to the UCO group. Furthermore, the UCO group demonstrated higher levels of pain and lower levels of functioning compared to the OMT and PUT groups. The downfall of the study is that the PUT group was more active than anticipated, so there were no significant differences in outcomes between the OMT and PUT groups. Additionally, the OMT group may have had more tremendous success if the OMT providers had provided individualized care to each participant within the OMT group.

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

This study can have a significant impact on clinical practice, especially when it comes to treating patients who are pregnant because many of these women struggle with low back pain due to the regular physiological changes that occur during pregnancy. It is essential to understand that manual therapy is safe to perform on pregnant women, and this study, in particular, showed that manual therapy does not increase the mother’s risk of having a high-risk pregnancy. The study only looked at outcomes through self-report questionnaires, so the results may have been biased since the people assessing the outcomes were the patients themselves; therefore, they were not blind to the group assignment. That said, they had no way of knowing if they were improving more with their treatment in comparison to women in the other groups.

Spinal Manipulation Vs Sham Manipulation for Nonspecific Low Back Pain: A Systematic Review and Meta-analysis

Author Names
Ruddock,J Sallis,H Ness,A MPhil R

Reviewer Name
Moya Nadège Koua

Reviewer Affiliation(s)
Duke Doctor of Physical Therapy

Paper Abstract
The purpose of this systematic review was to identify and critically evaluate randomized controlled trials of spinal manipulation vs sham manipulation in the treatment of nonspecific low back pain.Four electronic databases were searched from their inception to March 2015 to identify all relevant trials. Reference lists of retrieved articles were hand-searched. All data were extracted by 2 independent reviewers, and risk of bias was assessed using the Cochrane Back Review Group Risk of Bias tool. Nine randomized controlled trials were included in the systematic review, and 4 were found to be eligible for inclusion in a meta-analysis. Participants in the SM group had improved symptoms compared with participants receiving sham treatment. The majority of studies were of low risk of bias; however, several of the studies were small, the practitioner could not be blinded, and some studies did not conduct intention-to-treat analysis and had a high level of dropouts.There is some evidence that SM has specific treatment effects and is more effective at reducing nonspecific low back pain when compared with an effective sham intervention. However, given the small number of studies included in this analysis, we should be cautious of making strong inferences based on these results.

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
Greater reduction in pain scores among SM participants than those who received a sham placebo.When pain was examined immediately posttreatment and at follow-up, this conclusion held true.

Key Finding #2
According to seven trials, no evidence of between-group differences were reported and may have lacked power because sample sizes were small and did not report a priori power calculations.

Please provide your summary of the paper
This summary showed that when SM is compared to a successful sham intervention, it has particular treatment effects and reduces NSLBP more effectively. A comparable benefit was observed both immediately posttreatment and at follow-up despite the effect having a small-medium level of clinical importance. The use of various therapies, controls, and outcome measures, as well as varying standards of methodology between research, may be the cause of results that are inconsistent across all of the studies.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
As of right now , there is not enough data to guide practice but there is evidence that SM has some effects. Therefore, it could be beneficial to try SM to reduce NSLBP in the plan care.

Early use of thrust manipulation versus non-thrust manipulation: A randomized clinical trial

Author Names
Cook, C., Learman, K., Showalter, C., Kabbaz, V., O’ Halloran, B.

Reviewer Name
Aidan Gallagher, SPT

Reviewer Affiliation(s)
Duke University Doctor of Physical Therapy Division

Paper Abstract
The purpose of this study was to investigate the comparative effectiveness of early use of thrust (TM) and non-thrust manipulation (NTM) in sample of patients with mechanical low back pain (LBP). The randomized controlled trial included patients with mechanically reproducible LBP, ≥age 18-years who were randomized into two treatment groups. The main outcome measures were the Oswestry Disability Index (ODI) and a Numeric Pain Rating Scale (NPRS), with secondary measures of Rate of Recovery, total visits and days in care, and the work subscale of the Fears Avoidance Beliefs Questionnaire work subscale (FABQ-w). A two-way mixed model MANCOVA was used to compare ODI and pain, at baseline, after visit 2, and at discharge and total visits, days in care, and rate of recovery (while controlling for patient expectations and clinical equipoise). A total of 149 subjects completed the trial and received care over an average of 35 days. There were no significant differences between TM and NTM at the second visit follow-up or at discharge with any of the outcomes categories. Personal equipoise was significantly associated with ODI and pain. The findings suggest that there is no difference between early use of TM or NTM, and secondarily, that personal equipoise affects study outcome. Within-groups changes were significant for both groups.

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)?
No
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
There was no significant difference found between early use thrust and non thrust manipulations in pain and disability outcomes.

Key Finding #2
Both thrust and non thrust manipulations as part of a physical therapy plan of care can contribute to successful outcomes with improvements in outcome measures such as the FABQ-w, NPRS, and ODI.

Key Finding #3
No adverse effects were reported from either thrust or non thrust manipulations.

Key Finding #4
There is a source of variability in the study given that the physical therapists are encouraged to treat each patient with their own individualised plan following the second visit. This doesn’t affect differences noted after the second visit, but could influence differences found at discharge.

Please provide your summary of the paper
A group of patients with mechanical low back pain who were all over 18 years of age and had an in-session improvement in pain or ROM during the assessment phase of the clinical evaluation were recruited to the study. The clinicians all had relevant manual therapy experience. The patients were assigned to thrust or non thrust groups using the roll of a die, neither patients or clinicians were blinded. Clinicians selected appropriate thrust or non-thrust techniques to use based on which group the patient was in. All patients had a standard exercise program for the first two visits, but afterwards the clinicians were encouraged to design individualised plans for the patients. Outcome measures used included the FABQ-w, the NPRS, and the ODI which were done at baseline, after two visits, and at discharge, except the FABQ-w which was only done at baseline and after two visits. In conclusion it was found that there was no significant difference between thrust and non-thrust manipulations when used early in the treatment of lower back pain.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
This impacts clinical practice as if significant differences between thrust and non thrust manipulations were not found then they can perhaps be used interchangeably. The clinician could choose one or the other based on which they feel more confident in, which they feel the patient would be more comfortable with, or which one they believe the patient would respond better to- whether that is according to their impairment or psychosocial factors.

Cognitive functional therapy compared with core exercise and manual therapy in patients with chronic low back pain: randomised controlled trial

Author Names
Castro, J., Correia, L., de Sousa Donato, B., Arruda, B., Agulhari, F., Pellegrini, M., Belache, F., de Souza, C., Fernandez, J., Nogueira, L., Reis, F., de Sa Ferreira, A., Meziat-Filho, N.

Reviewer Name
Samantha Anderson, SPT

Reviewer Affiliation(s)
Duke University Doctorate of Physical Therapy Program

Paper Abstract
Cognitive functional therapy (CFT) is a physiotherapy-led intervention that has evolved from an integration of foundational behavioral psychology and neuroscience within the physiotherapist practice directed at the multidimensional nature of chronic low back pain (CLBP). The current evidence about the comparative effectiveness of CFT for CLBP is still scarce. We aimed to investigate whether CFT is more effective than core training exercise and manual therapy (CORE-MT) in pain and disability in patients with CLBP. A total of 148 adults with CLBP were randomly assigned to receive 5 one-hour individualized sessions of either CFT (n = 74) or CORE-MT (n = 74) within a period of 8 weeks. Primary outcomes were pain intensity (numeric pain rating scale, 0-10) and disability (Oswestry Disability Index, 0-100) at 8 weeks. Patients were assessed preintervention, at 8 weeks and 6 and 12 months after the first treatment session. Altogether, 97.3% (n = 72) of patients in each intervention group completed the 8 weeks of the trial. Cognitive functional therapy was more effective than CORE-MT in disability at 8 weeks (MD = -4.75; 95% CI -8.38 to -1.11; P = 0.011, effect size= 0.55) but not in pain intensity (MD = -0.04; 95% CI -0.79 to 0.71; P = 0.916). Treatment with CFT reduced disability, but the difference was not clinically important compared with CORE-MT postintervention (short term) in patients with CLBP. There was no difference in pain intensity between interventions, and the treatment effect was not maintained in the mid-term and long-term follow ups.

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)?
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
Cognitive Functional Therapy showed more improvement in disability at 8 weeks than CORE-MT.

Key Finding #2
Cognitive Functional Therapy showed no difference in disability when compared to CORE-MT in the 6 and 12 month follow ups.

Key Finding #3
There was no difference in pain intensity or patient satisfaction between the Cognitive Functional Therapy group and the CORE-MT group.

Key Finding #4
This study used a larger sample size, had different physical therapists for each treatment group, and lost fewer to follow-up, when compared to previous studies, to provide more accurate and reliable data regarding this subject. This study pointed out that prior studies showing large differences across multiple time points had conflicts and biases that alter the research. While there is a difference, it is seen only in regard to levels of disability and only seen at the 8 week follow-up.

Please provide your summary of the paper
This study examined the differences in pain and disability when treating chronic low back pain from a biopsychosocial perspective compared to a body structure and function perspective. Prior studies found differences in the short, mid, and long term follow ups, but this study sought to reexamine those findings due to multiple conflicts and biases in the previous studies. The results showed that when a patient was treated using Cognitive Functional Therapy (CFT) short term improvements in disability were greater than with core exercises and manual therapy (CORE-MT). The physical therapist for the CFT group worked on gaining patient understanding of causes of their pain, worked to increase self efficacy, taught patients good body mechanics and gradual exposure to reduce fear avoidance, and discussed the benefits of sleep and general physical activity. The following tools were used to quantify outcomes: a numeric pain rating scale for pain intensity, the Oswestry Disability Index for disability, the Global Perceived Effect Scale for overall patient perception of effect, and a questionnaire for patient satisfaction. The improvement in disability within the CFT group was greater in the short-term (8 week) follow-up; no differences were found between the groups for the other outcomes at the 8 week follow-up. However, the mid and long term follow-ups showed no differences between the groups for disability, pain, global perceived effect, or patient satisfaction.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
If a patient’s main goal is to have less disability related to their chronic low back pain, CFT can make that happen sooner than CORE-MT. Since physical therapists can use multiple methods to treat their patients, rather than sticking strictly to one method as this clinical trial did, a combination of these could be used as a treatment plan for a patient. CFT can be used to treat patients in addition to treating them with manual therapy and exercises. This is one way to incorporate the biopsychosocial model into treatment as more research is showing that chronic low back pain is not a purely physical condition.

The Effect of Spinal Manipulative Therapy on Pain Relief and Function in Patients with Chronic Low Back Pain: An Individual Participant Data Meta-Analysis.

Article: Zoete A, Rubinstein S, de Boer M, Ostelo R, Underwood M, Hayden J, Buffart L, et al. The Effect of Spinal Manipulative Therapy on Pain Relief and Function in Patients with Chronic Low Back Pain: An Individual Participant Data Meta-Analysis. Physiotherapy. 2021 September; 112: 121–34. https://doi.org/10.1016/j.physio.2021.03.006.

Study Design: Systematic Review and Meta-Analysis

Abstract: Background – A 2019 review concluded that spinal manipulative therapy (SMT) results in similar benefit compared to other interventions for chronic low back pain (LBP). Compared to traditional aggregate analyses individual participant data (IPD) meta-analyses allows for a more precise estimate of the treatment effect.

Purpose – To assess the effect of SMT on pain and function for chronic LBP in a IPD meta-analysis.

Data sources – Electronic databases from 2000 until April 2016, and reference lists of eligible trials and related reviews.

Study selection – Randomized controlled trials (RCT) examining the effect of SMT in adults with chronic LBP compared to any comparator.

Data extraction and data synthesis – We contacted authors from eligible trials. Two review authors independently conducted the study selection and risk of bias. We used GRADE to assess the quality of the evidence. A one-stage mixed model analysis was conducted. Negative point estimates of the mean difference (MD) or standardized mean difference (SMD) favors SMT.

NIH Risk Bias: 7/8 (Low risk of bias)

Key Findings of Study:

Spinal manipulative therapy (SMT) appears to be a good option for the treatment of low-back pain (LBP)

SMT provides similar outcomes to recommended interventions for pain relief and improvement of functional status in patients with LBP

Moderate quality evidence that SMT has similar effects as spinal mobilization

Reviewer Summary: This systematic review and meta-analysis has a low-risk bias. The use of individual participant data (IPD) meta-analysis made the selection of the randomized controlled trials more rigorous and allowed for a more accurate estimate of the treatment effect. This meta-analysis once again displays evidence that SMT is effective in treatment of chronic LBP.

Manual Therapy in Cervical and Lumbar Radiculopathy: A Systematic Review of the Literature.

Article: Kuligowski, T., Skrzek, A., & Cieślik, B. (2021). Manual Therapy in Cervical and Lumbar Radiculopathy: A Systematic Review of the Literature. International journal of environmental research and public health, 18(11), 6176.

Full Text

Study Design: Systematic Review Abstract: The aim of this study was to describe and update current knowledge of manual therapy accuracy in treating cervical and lumbar radiculopathy, to identify the limitations in current studies, and to suggest areas for future research. The study was conducted according to PRISMA guidelines for systematic reviews. A comprehensive literature review was conducted using PubMed and Web of Science databases up to April 2020. The following inclusion criteria were used: (1) presence of radiculopathy; (2) treatment defined as manual therapy (i.e., traction, manipulation, mobilization); and (3) publication defined as a Randomized Controlled Trial. The electronic literature search resulted in 473 potentially relevant articles. Finally, 27 articles were accepted: 21 on cervical (CR) and 6 in lumbar radiculopathy (LR). The mean PEDro score for CR was 6.6 (SD 1.3), and for LR 6.7 (SD 1.6). Traction-oriented techniques are the most frequently chosen treatment form for CR and are efficient in reducing pain and improving functional outcomes. In LR, each of the included publications used a different form of manual therapy, which makes it challenging to summarize knowledge in this group. Of included publications, 93% were either of moderate or low quality, which indicates that quality improvement is necessary for this type of research.

NIH Risk of Bias Score: 7/8 (Low Risk of Bias) Key Findings of the Study:

1. The authors followed study design and intent consistent with their PROSPERO research proposition and used an adequate PRISMA RCT search strategy.

2. The studies included in this SR had an averaged PEDRO score of 6.65, representing low to moderate overall quality, limiting confidence in findings.

3. Definitions, parameters, indications, and executions of manual therapy techniques for those with CR or LR were heterogenous, limiting ability to adequately study and make conclusions on descriptive accuracy and true effect in functional outcomes.

4. Many studies (in particular those studying LR) included diverse and multimodal strategies with limited descriptive characteristics, making it difficult to understand isolated effect of manual therapy on primary outcomes.

5. For those with LR, exercise programs included activation of “core muscles”, spinal mobilization, and traction may be best. Those with acute, moderate-severe impairments seemed to benefit most from an active trunk exercise program, and those with more chronic symptoms seemed to benefit from flexion-distraction oriented exercises. Groups who received a combination of exercise and manual therapy had superior outcomes compared to those who received manual therapy alone.

6. For those with CR, exercise programs included deep neck flexor stabilization, scapular retraction, stretching, active range of motion, and isometric exercises around the shoulder girdle. CR groups who received a combination of exercise and manual therapy had functional outcomes that were superior to those receiving manual therapy alone.

7. Comparison of exercise programs was not the intent of this study, and therefore is improper to draw conclusions on exercise program effectiveness for those with radiculopathic conditions.

8. The most common manual therapy techniques included appears to be mechanical traction but based on available literature and findings of this review, a multimodal treatment approach with traction, spinal mobilizations, and exercise appears to optimize patient reported outcomes.

Reviewer Summary: Due to a combination of multimodal interventions, poor descriptions of manual therapy performed, and limited consistent use of primary outcome measures for CR & LR, it is difficult to understand the true role of manual therapy for those with radiculopathic conditions. It appears including traction of some form with exercise, spinal mobilization, and avoiding passive modalities may be best for patients with radiculopathic presentations. There does not appear to be a superior form of manual therapy for those with CR or LR, as spinal mobilizations, manipulations, manual/mechanical traction, and neural mobilizations were included in this review with a seemingly positive impact on functional outcomes. It appears that manual therapy techniques, along with an exercise program, should be included for those with radiculopathic conditions to maximize functional outcomes. Future directions for manual therapy and radiculopathy research must include better descriptive characteristics on the indication, execution, and post-treatment response. Additionally, standardization of exercise programs is recommended to better understand effects of manual therapy on functional outcomes for those with CR and LR.

Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial.

Article: Cook C, Learman K, Showalter C, Kabbaz V, O’Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8.

Full Text

Study Design: Randomized Controlled Trial

Abstract:

The purpose of this study was to investigate the comparative effectiveness of early use of thrust (TM) and non-thrust manipulation (NTM) in sample of patients with mechanical low back pain (LBP). The randomized controlled trial included patients with mechanically reproducible LBP, ≥ age 18-years who were randomized into two treatment groups. The main outcome measures were the Oswestry Disability Index (ODI) and a Numeric Pain Rating Scale (NPRS), with secondary measures of Rate of Recovery, total visits and days in care, and the work subscale of the Fears Avoidance Beliefs Questionnaire work subscale (FABQ-w). A two-way mixed model MANCOVA was used to compare ODI and pain, at baseline, after visit 2, and at discharge and total visits, days in care, and rate of recovery (while controlling for patient expectations and clinical equipoise). 149 subjects completed the trial and received care over an average of 35 days. There were no significant differences between TM and NTM at the second visit follow-up or at discharge with any of the outcomes categories. Personal equipoise was significantly associated with ODI and pain. The findings suggest that there is no difference between early use of TM or NTM, and secondarily, that personal equipoise affects study outcome. Within-groups changes were significant for both groups.

NIH Risk of Bias Score: 8/14 (Moderate to High Risk of Bias)

Key Findings of the Study:

1. There were no differences between groups for those who received thrust manipulation and non-thrust manipulation

2. Therapist expectations of a benefit of one technique over another, did influence overall patient outcomes

3. Outcomes were to discharge only (on average about 35 days)

Reviewer Summary: The study found no between groups differences in thrust versus non-thrust manipulation but there were several methodological concerns associated with the study that could influence findings. Firstly, the treatment selection of thrust or non-thrust was only controlled for the first two visits. Secondly, the authors only looked at outcomes to discharge, which was about 45 days on average. The most interesting aspect of the study was that therapist expectations (clinical equipoise) did influence outcomes in the patients that received care. This suggests that a clinician’s preference of treatment in a randomized trial could influence overall outcomes and should be measured at baseline. Although an interesting study, further works should fairly compare thrust and non-thrust manipulation.

Spinal manual therapy in infants, children and adolescents: A systematic review and meta-analysis on treatment indication, technique and outcomes

Author Names

Femke Driehuis, Thomas J. Hoogeboom, Maria W. G. Nijhuis-van der Sanden, Rob A. de Bie, J. Bart Staal

Reviewer Name

Semat Adekoya, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background Studies on effectiveness and safety of specific spinal manual therapy (SMT) techniques in children, which distinguish between age groups, are lacking. Objective To conduct a systematic review of the evidence for effectiveness and harms of specific SMT techniques for infants, children and adolescents. Methods PubMed, Index to Chiropractic Literature, Embase, CINAHL and Cochrane Library were searched up to December 2017. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1–18 years), were included to determine effectiveness. Controlled and observational studies and case reports were included to examine harms. One author screened titles and abstracts and two authors independently screened the full text of potentially eligible studies for inclusion. Two authors assessed risk of bias of included studies and quality of the body of evidence using the GRADE methodology. Data were described according to PRISMA guidelines and CONSORT and TIDieR checklists. If appropriate, random-effects meta-analysis was performed. Results Of the 1,236 identified studies, 26 studies were eligible. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis. Five case reports described severe harms after HVLA manipulations in four infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment. Conclusions Based on GRADE methodology, we found the evidence was of very low quality; this prevented us from drawing conclusions about the effectiveness of specific SMT techniques in infants, children and adolescents. Outcomes in the included studies were mostly parent or patient-reported; studies did not report on intermediate outcomes to assess the effectiveness of SMT techniques in relation to the hypothesized spinal dysfunction. Severe harms were relatively scarce, poorly described and likely to be associated with underlying missed pathology. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique in infants, children and adolescents. We encourage future research to describe effectiveness and safety of specific SMT techniques instead of SMT as a general treatment approach.

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?

Cannot Determine, Not Reported, Not Applicable

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

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

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

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

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

Was publication bias assessed?

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

Cannot Determine, Not Reported, Not Applicable

Key Finding #1

There is very low quality of evidence in the effectiveness of gentle, low-velocity mobilizations in infants. The evidence of HVLA manipulation in children and/or adolescents is uncertain

Key Finding #2

The relationship between specific treatment and the effect on spinal dysfunction is unclear.

Key Finding #3

HVLA manipulations in infants and young children may lead to severe harm (or can be associated with missed underlying pathology).

Key Finding #4

There is a great need for high quality research in order to increase certainty about SMT and its effectiveness.

Please provide your summary of the paper

Many of the studies and case reports shown displayed “moderate to high risk of bias”, impacting the overall quality of the evidence presented. There was also a major lack of distinction between which manual therapy techniques were performed. In infants there were “Adverse events” that took place following cervical manipulations including temporary paralysis and death. However, these events could not be directly linked to the cervical manipulations performed and rather were hypothesized to be a result of “missed underlying pathology”. Similar patterns occur in the remaining age groups. Overall, the effectiveness remains uncertain. The reports of severe harm following manipulation are limited and may be underreported. Gentle, slow mobilizations appear to be safe in infants, children, and adolescents, but caution should be taken in cervical and full spine HVLA as they may be associated with severe harms (mentioned above). The authors concluded that they were unable to draw clinically meaningful conclusions on the effectiveness of certain spinal manual therapy techniques due to the low quality of evidence. There were some shortcomings reported (e.g. rib fracture, paralysis, stiffness), but many of these things could not be concluded to be a direct result of SMT.

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

This systematic review/meta-analysis in my opinion served as an alert that more research needs to be done in this area. The negative effects associated with SMT in this study in infants and children are concerning, however can also be attributed to missed underlying diseases. It is imperative to better understand the relationship between SMT and the developing child so clinicians are not causing unnecessary harm to our most vulnerable patients. If adverse effects are truly the result of SMT, then steps need to be taken to ensure a fully developed MSK system is present prior to the performance of SMT. An important attribute that should be included in future research is the specification about which SMT was used rather than simply terming the act as “manual therapy”.

Randomized Multicenter Clinical Trial of Myofascial Physical Therapy in Women with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) and Pelvic Floor Tenderness

Author Names

FitzGerald, M; Payne, C; Lukacz, E; Yang, C; Peters, K; Chai, T; Nickel, J; Hanno, P; Kreder, K; Burks, D; Mayer, R; Kotarinos, R; Fortman, C; Allen, T; Fraser, L; Mason-Cover, M; Furey, C; Odabachian, L; Sanfield, A; Chu, J; Huestis, K; Tata, G, Dugan, N; Sheth, H; Bewyer, K; Anaeme, A; Newton, K; Featherstone, W; Halle-Podell, R; Cen, L; Landis, J; Propert, K; Foster, H; Kusek, J; Nyberg, L

Reviewer Name

Morgan Baxter, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objectives: To determine the efficacy and safety of pelvic floor Myofascial Physical Therapy (MPT) in women with newly-symptomatic IC/PBS, as compared to Global Therapeutic Massage (GTM). Materials and Methods: A randomized controlled trial of 10 scheduled treatments of MPT vs. GTM was performed at 11 clinical centers located in North America. We recruited women with IC/PBS with demonstrable pelvic floor tenderness on physical examination and a limitation of no more than 3 years symptom duration. The primary outcome was the proportion of responders defined as ‘moderately improved’ or ‘markedly improved’ in overall symptoms compared to baseline on a 7-point scale Global Response Assessment (GRA). Secondary outcomes included ratings for pain, urgency, frequency; the O’Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) and reports of adverse events. We compared response rates between treatment arms using the exact conditional version of the Mantel-Haenszel test to control for clustering by clinical center. For secondary efficacy outcomes, cross-sectional descriptive statistics and changes from baseline were calculated. Results: Eighty-one women randomized to the two treatment groups had similar symptoms at baseline. The GRA response rate was 26% in the GTM group and 59% in the MPT group (p=0.0012). Pain, urgency, and frequency ratings and in ICSI/ICPI decreased in both groups during follow-up and were not significantly different between the groups. Pain was the most common adverse event, occurring at similar rates in both groups. There were no serious adverse events reported. Conclusions: A significantly higher proportion of women with IC/PBS responded to treatment with MPT than with GTM. MPT may be a beneficial therapy in women with this syndrome.

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

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

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

Were study participants and providers blinded to treatment group assignment?

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

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

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

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

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

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

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

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?

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

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

Myofascial Physical Therapy treatment for Interstitial Cystitis/Painful Bladder Syndrome caused 59% participants to rate their symptoms as “moderately improved” or “markedly improved”

Key Finding #2

Although the link between bladder syndromes and pain and tightness in the abdomen, hip, and pelvic floor is not entirely understood, myofascial physical therapy appears to be a successful treatment

Please provide your summary of the paper

Women with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) with symptoms that had been occurring for 3-36 months and who rated their bladder pain, frequency, and urgency a 3/10 with pelvic floor tenderness were enrolled in this study to determine the effect of Myofascial Physical Therapy (MPT) versus Global Therapeutic Massage (GTM). Since IC/PBS is associated with tight connective tissue of the abdomen, pelvis, and pelvic floor, the MPT group received internal and external trigger point release and connective tissue manipulation. After up to 10, 60-minute treatment session, it was found that there were significantly more responders to MPT than GTM (p=0.0012). A responder was classified as someone who rated their symptoms as “moderately improved” or “markedly improved” compared to baseline. There was no significant difference between groups for the secondary outcomes of pain, urgency, or frequency of voiding after the 12-week 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 data suggests MPT can be used to help treat IC/PBS by focusing on the connective tissue of the abdominal wall, pelvic floor, and pelvis. One limitation is that this study only included women with IC/PBS who had pelvic floor tenderness upon examination. Therefore, it is unknown how these results would apply to someone without pelvic floor tenderness. Additionally, there was loss to follow up after the 12-week trial, so there was no data that showed the longer-term effects of the treatment. Overall, MPT appears successful for treatment of symptoms of IC/PBS, but more research is needed to determine if these results can be applied to those patients outside of the narrow inclusion criteria and the effect of the treatment long-term.

Lumbopelvic manipulation for the treatment of patients with patellofemoral pain syndrome: development of a clinical prediction rule

Author Names

Iverson, C., Sutlive, T., Crowell, M., Morrell, R., Perkins, M., Garber, M., Moore, J., Wainner, R.

Reviewer Name

Alyssa Bush, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

The purpose of this study was to investigate the effectiveness of lumbopelvic manipulation at reducing symptoms of patellofemoral pain syndrome (PFPS) and to create a clinical prediction rule for the potential of immediate success of lumbopelvic manipulation in patients with PFPS. A prospective cohort/predictive validity study was conducted and included fifty subjects, male and female, between the ages of 18 and 45 years with PFPS. Each patient underwent a standardized history and physical examination, and then performed three traditionally pain-provoking exercises followed by use of the Numeric Pain Rating Scale (NPRS) and the Global Rating of Change Questionnaire to evaluate severity of symptoms. After the assessment, all patients were treated with lumbopelvic manipulation, and then underwent a re-test of the three exercises. The criteria for success was a 50% or greater reduction in pain on the NPRS, or moderate or greater improvement on the Global Rating of Change Questionnaire after lumbopelvic manipulation. Five predictor variables were established using a binary logistic regression model, and the strongest predictor of success was hip internal rotation asymmetry of greater than 14 degrees. A clinical prediction rule was established to predict success of lumbopelvic manipulation in patients with PFPS, but more research is needed to validate the clinical prediction rule due to a limited sample size and omission of some predictor variables.

NIH Risk of Bias Tool

Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies

Was the research question or objective in this paper clearly stated?

Was the study population clearly specified and defined?

Was the participation rate of eligible persons at least 50%?

Cannot Determine, Not Reported, Not Applicable

Were all the subjects selected or recruited from the same or similar populations (including the same time period)? Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants?

Was a sample size justification, power description, or variance and effect estimates provided?

For the analyses in this paper, were the exposure(s) of interest measured prior to the outcome(s) being measured?

Was the timeframe sufficient so that one could reasonably expect to see an association between exposure and outcome if it existed?

For exposures that can vary in amount or level, did the study examine different levels of the exposure as related to the outcome (e.g., categories of exposure, or exposure measured as continuous variable)?

Were the exposure measures (independent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?

Was the exposure(s) assessed more than once over time?

Were the outcome measures (dependent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?

Were the outcome assessors blinded to the exposure status of participants?

Cannot Determine, Not Reported, Not Applicable

Was loss to follow-up after baseline 20% or less?

Were key potential confounding variables measured and adjusted statistically for their impact on the relationship between exposure(s) and outcome(s)?

Key Finding #1

45% of patients with patellofemoral pain syndrome (PFPS) experienced a reduction in symptoms that met the study’s criteria for success immediately following lumbopelvic manipulation.

Key Finding #2

The strongest predictor of success of lumbopelvic manipulation was hip internal rotation asymmetry of greater than 14 degrees, which increased the post-test probability of success of lumbopelvic manipulation to 80%.

Please provide your summary of the paper

The study found that 45% of patients with patellofemoral pain syndrome (PFPS) experienced a reduction in symptoms that met the study’s criteria for success immediately following lumbopelvic manipulation. This study evaluated patient-reported symptoms immediately after lumbopelvic manipulation, which differed from previous studies that have been conducted. Notably, the strongest predictor of success was hip internal rotation asymmetry; if a patient in this group had asymmetry in hip internal rotation of more than 14 degrees, post-test probability for success of lumbopelvic manipulation increased to 80%. Although this is a notable finding, the study could not establish a cause and effect relationship between lumbopelvic manipulation and decreased PFPS symptoms due to the lack of a control group or a competing intervention in the study. The authors developed a clinical prediction rule to help determine which patients with PFPS may be most appropriate for a lumbopelvic manipulation as an intervention for PFPS. Five variables were established as predictors for success by linear regression analysis. The five variables were: side to side difference in hip internal rotation greater than or equal to 14 degrees, ankle dorsiflexion (knee flexed) greater than 16 degrees, navicular drop greater than three mm, no self-reported stiffness with sitting greater than 20 minutes, and squatting reported as the most painful activity. However, the sample size was limited and further research is necessary to establish validity of this clinical prediction rule. Although more research is needed in this area, the study suggests that lumbopelvic manipulation may be a successful intervention to reduce symptoms in patients with PFPS.

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 suggests that lumbopelvic manipulation can be an effective intervention in patients with PFPS, particularly in those patients with hip internal rotation asymmetry greater than 14 degrees. Of clinical significance, the study suggested that lumbopelvic manipulation may lead to a decrease in self-reported pain scores in patients with PFPS. Although the clinical prediction rule was not validated, the results of this study established five predictor variables that can assist clinicians in considering which patients with PFPS may respond most favorably to lumbopelvic manipulation. Ultimately, this may help clinicians be more efficient in identifying PFPS patients who may respond positively to lumbopelvic manipulation and may be used in patients with irritable symptoms in an effort to decrease pain level in patients with PFPS.

Spinal Manipulation for Subacute and Chronic Lumbar Radiculopathy: A Randomized Controlled Trial

Author Names

Ghasabmahaleh, SH., Rezasoltani, Z., Dadarkhah, A., Hamidipanah, S., Mofrad, RK., Najafi, S

Reviewer Name

Casie Coffman SPT, NBC-HWC

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

OBJECTIVE: We evaluated the efficacy of spinal manipulation for the management of nonacute lumbar radiculopathy. METHODS: In a university hospital we performed a randomized controlled trial with 2 parallel arms. Patients (n = 44) with unilateral radicular low back pain lasting more than 4 weeks were randomly allocated to manipulation and control groups. The primary outcome was the intensity of the low back pain on a visual analog scale. The secondary outcome was the Oswestry Disability Questionnaire (ODI) score. We also measured spinal ranges of motion. The assessments were carried out at the baseline, immediately after intervention, and at 3 months’ follow-up. All patients underwent physiotherapy. The manipulation group received three sessions of manipulation therapy 1 week apart. For manipulation, we used Robert Maigne’s technique. RESULTS: Both groups experienced a decrease in back and leg pain significantly (all P ≤ 0.003). However, only the manipulation group showed significantly favorable results in the Oswestry scores (P < 0.001), and the straight leg raise test (P = 0.001). All ranges of motion increased significantly with manipulation (all P < 0.001), but the control group showed favorable results only in right and left rotations and in extension (all P < 0.001). Between-group analyses showed significantly better outcomes for manipulation in all measurements (all P ≤ 0.009) with large effect sizes. CONCLUSION: Spinal manipulation improves the results of physiotherapy over a period of 3 months for patients with subacute or chronic lumbar radiculopathy.

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?

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

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

Were study participants and providers blinded to treatment group assignment?

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

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

Cannot Determine, Not Reported, or Not Applicable

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

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

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

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

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

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)?

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

Both groups experienced significant reduction in pain rating post-intervention. The manipulation group however also demonstrated a significant difference in Oswestry Disability Index Score, indicating improved disability. The manipulation group maintained these outcomes on assessment 3 months post-intervention.

Key Finding #2

Although the control group demonstrated significant improvements in some ranges of motion, the manipulation group showed significantly increased range of motion in all directions (flexion, extension, rotation, and side bending) post-intervention.

Key Finding #3

The manipulation group showed a significant difference in the number of abnormal straight leg raise tests post-treatment.

Please provide your summary of the paper

The study found between group differences in ODI score, range of motion, and straight leg raise when comparing manipulation and non-manipulation groups in the treatment of subacute and chronic lumbar radiculopathy. Assessment 3 months post-intervention demonstrated between group differences in pain level rated on a visual analog scale as well. Participants were randomly assigned to their group, and range of motion and straight leg raise tests were assessed blind to group assignments to prevent bias. With large effect sizes, this study suggests that using spinal manipulation in conjunction with other treatments (pain medication, hot pack, transcutaneous electrical stimulation, ultrasound, and exercise) adds benefit in the treatment of subacute and chronic 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.

Spinal manipulation is a safe and valuable additive treatment for subacute and chronic lumbar radiculopathy. A consideration is length of impact. Since this study assessed the interventions’ effects up to 3 months post treatment, a future area of research may involve inquiring about the long term effects beyond 3 months.

The effects of high-velocity low-amplitude thrust manipulation and mobilisation techniques on pressure pain threshold in the lumbar spine

Author Names

Thomson, O., Haig, L., & Mansfield, H.

Reviewer Name

Erin Dennis, SPT

Reviewer Affiliations

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective: To compare changes in pressure pain threshold (PPT) following spinal high-velocity low-amplitude thrust manipulation (HVLAT) and spinal mobilisation. Design: Fifty asymptomatic subjects (mean age 27 (6) years; 29 males and 21 females) volunteered to participate in a randomised controlled, singled blinded design study. Subjects were screened for suitability and were randomly allocated into one of three intervention groups where they received either a unilateral spinal HVLAT or a spinal mobilisation of the lumbar spine, or a sham ‘laser’ procedure (control). PPT measurements were made immediately pre- and post-intervention, using a hand-held algometer which was positioned directly over the lumbar spinous process. A two-way ANOVA with repeated measures was conducted to determine PPT changes between the groups. Statistical significance was set at the 0.05 level. Results: There were no significant differences in PPT across time for each of the groups ( P = 0.584). The mobilisation group displayed a small increase, though not a significant change in the mean pressure pain threshold (0.434(0.55) kg/cm 2 ), although effect size was considered to be large (ES = 0.78). The HVLAT group demonstrated a decrease in the mean PPT (−0.173(0.48)) (ES = 0.36, small), and a smaller decrease was noted for the control group (0.105(0.425) kg/cm 2 ) (ES = 0.25, small). Conclusion: Neither spinal HVLAT nor mobilisation had a significant effect on PPT of the lumbar spine in asymptomatic subjects. Only spinal mobilisation appeared to have a greater mean increase in PPT and effect size than the control group. Further investigation into the hypoalgesic effects of these techniques on symptomatic subjects is suggested.