Lumbopelvic

A Comparison Between Two Physical Therapy Treatment Programs for Patients with Lumbar Spinal Stenosis A Randomized Clinical Trial

Article Full Title

A Comparison Between Two Physical Therapy Treatment Programs for Patients with Lumbar Spinal Stenosis A Randomized Clinical Trial

Author Names

Whitman, J; Flynn, T; Childs, J; Wainner, R; Gill, H; Ryder, M; Garber, M; Bennett, A; Fritz, J

Reviewer Name

Lauren Dreusicke

Reviewer Affiliation(s)

Duke University DPT

Paper Abstract

Study Design. Multicenter randomized, controlled trial. Objective. To compare two physical therapy programs for patients with lumbar spinal stenosis. Summary of Background Data. Scant evidence exists regarding effectiveness of nonsurgical management programs for lumbar spinal stenosis. Methods. Fifty-eight patients with lumbar spinal stenosis were randomized to one of two 6-week physical therapy programs. One program included manual physical therapy, body weight supported treadmill walking, and exercise (Manual Physical Therapy, Exercise, and Walking Group), while the other included lumbar flexion exercises, a treadmill walking program, and subtherapeutic ultrasound (Flexion Exercise and Walking Group). Perceived recovery was assessed with a global rating of change scale. Secondary outcomes included: Oswestry, a numerical pain rating scale, a measure of satisfaction, and a treadmill test. Testing occurred at baseline, 6 weeks, and 1 year. Perceived recovery, pain, and other healthcare resources used were collected with a long-term follow-up questionnaire. Results. A greater proportion of patients in the manual physical therapy, exercise, and walking group reported recovery at 6 weeks compared with the flexion exercise and walking group (P = 0.0015), with a number needed to treat for perceived recovery of 2.6 (confidence interval, 1.8–7.8). At 1 year, 62% and 41% of the manual therapy, exercise, and walking group and the flexion exercise and walking group, respectively, still met the threshold for recovery. Improvements in disability, satisfaction, and treadmill walking tests favored the manual physical therapy, exercise, and walking group at all follow-up points. Conclusions. Patients with lumbar spinal stenosis can benefit from physical therapy. Additional gains may be realized with the inclusion of manual physical therapy interventions, exercise, and a progressive body-weight supported treadmill walking program.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

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

Yes

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

Yes

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

Yes

Were study participants and providers blinded to treatment group assignment?

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

Key Finding #1

The group receiving physical interventions including manual therapy reported a greater proportion of recovery at the 6-week point when compared with those of the group receiving flexion exercises and the walking physical therapy program.

Key Finding #2

At all follow-up points, improvements were seen in level of disability, treadmill walking tests, and patient satisfaction with the manual therapy and walking physical therapy intervention group.

Key Finding #3

Physical therapy interventions can be beneficial for patients with the presence of lumbar spinal stenosis as a form of nonsurgical treatment.

Please provide your summary of the paper

This randomized clinical trial explored the potential for a clinically important difference between two intervention groups for patients with lumbar spinal stenosis (LSS). The two treatment groups were derived from a group of 58 enrolled patients ≥ 50 years old with MRI findings consistent with lumbar spinal stenosis, pain in the lumbopelvic region and lower extremities, and patient rating of symptom severity better in sitting than standing or walking. The group randomly assigned to receive manual therapy in addition to exercise and a progressive walking program showed increased benefits and notable improvements in outcome measures used to track patient progress when compared to the second patient group that received no manual therapy as part of their physical therapy interventions. The manual therapy performed in the group consisted of both thrust and non-thrust manipulation of areas of the spine and lower extremities and manual stretching and strengthening exercises. The patient global rating of change scale (GRC) was used as a primary outcome measure collected. Secondary measures included the Modified Oswestry Disability Index (OSW), the Satisfaction Subscale of Spinal Stenosis Scale (SSS), a Numerical Pain Rating Scale (NPRS), and a walking tolerance test. After follow-ups at a 6-week, 1-year, and long-term time period, there was an association of additional improvements in many domains of patient care and outcome measures with the use of manual physical therapy interventions in concordance with exercise and progressive body weight supported treadmill walking when compared with the group receiving no manual physical therapy intervention. Additionally, this study supports the use of nonsurgical treatment and intervention for patients with LSS. Limitations to this study include unspecified timelines for data collected past the one-year follow up and a relatively small sample size of patients.

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

From this trial, we can derive that there is an association between manual therapy as part of a physical therapy treatment plan and improved patient outcomes for those with LSS. These improvements were specifically seen in patient pain levels, function, and ambulation measures, all values which are commonly important to the patient. This trial can serve to guide future developments of manual therapy used in interventions by looking further into controlling more variables between the two intervention groups to specifically attribute patient improvement to manual therapy techniques used. The results of this study provide clinicians with evidence-based techniques that can be implemented in the clinic and dosing suggestions for the use of manual therapy interventions for patients with LSS. In the clinic, this study also provides identification of available outcome measures that demonstrate a good ability to track patient progress throughout visits and collect data through many different patient domains and serves as an opportunity to build patient confidence and comfort surrounding the introduction of manual therapy into their treatment plan.

Spinal manipulation in the treatment of patients with MRI-confirmed lumbar disc herniation and sacroiliac joint hypomobility: a quasi-experimental study

Article Full Title

Spinal manipulation in the treatment of patients with MRI-confirmed lumbar disc herniation and sacroiliac joint hypomobility: a quasi-experimental study

Author Names

Shokri, E., Kamali, F., Sinaei, E., & Ghafarinejad, F

Reviewer Name

Joyel Edgecombe, SPT

Reviewer Affiliation(s)

Doctor of Physical Therapy Program, Duke University

Paper Abstract

Background: To investigate the effect of lumbar and sacroiliac joint (SIJ) manipulation on pain and functional disability in patients with lumbar disc herniation (LDH) concomitant with SIJ hypomobility. Methods: Twenty patients aged between 20 and 50 years with MRI-confirmed LDH who also had SIJ hypomobility participated in the trial in 2010. Patients who had sequestrated disc herniation were excluded. All patients received five sessions of spinal manipulative therapy (SMT) for the SIJ and lumbar spine during a 2-week period. Back and leg pain intensity and functional disability level were measured with a numerical rating scale (NRS) and the Oswestry Disability Index (ODI) at baseline, immediately after the 5th session, and 1 month after baseline. Results: A significantly greater mean improvement in back and leg pain was observed in the 5th sessions and 1 month after SMT. Mean changes in ODI in the 5th session and 1 month after treatment also showed significant improvement. The MCIC for NRS and ODI scores in the present study were considered 20 and 6 points, respectively. Therefore, the mentioned improvements were not clinically significant in the 5th session or at 1-month follow-up. Conclusion: Five sessions of lumbar and SIJ manipulation can potentially improve pain and functional disability in patients with MRI-confirmed LDH and concomitant SIJ hypomobility. Trial registration: Irct.ir (Identifier: IRCT2017011924149N33), registered 19 February 2017 (retrospectively registered). Keywords: Back pain; Lumbar disc herniation; Sacroiliac joint; Spinal manipulation.

NIH Risk of Bias Tool

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

Was the study question or objective clearly stated?

Yes

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

Yes

Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest?

Yes

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

Cannot Determine, Not Reported, Not Applicable

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

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

Yes

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

Yes

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

Cannot Determine, Not Reported, Not Applicable

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

Yes

Did the statistical methods examine changes in outcome measures from before to after the intervention? Were statistical tests done that provided p values for the pre-to-post changes?

Yes

Were outcome measures of interest taken multiple times before the intervention and multiple times after the intervention (i.e., did they use an interrupted time-series design)?

If the intervention was conducted at a group level (e.g., a whole hospital, a community, etc.) did the statistical analysis take into account the use of individual-level data to determine effects at the group level?

Cannot Determine, Not Reported, Not Applicable

Key Finding #1

The numerical rating scale (NRS) score for back pain showed statistically significant improvement in the 5th session (P = 0.034) and at 1-month follow-up (P = 0.047) compared to the baseline value. However, the MCIC for NRS scores in the study was 20 points, the score shows no clinical significance in the 5th session or at 1-month followup.

Key Finding #2

The ODI scores indicated statistically significant improvement in the 5th session (P = 0.001) and at 1-month follow-up (P = 0.001). However, the MCIC for ODI score in the present study was 6 points, the improvements were not considered clinically significant at the 5th session or at 1-month follow-up

Key Finding #3

In 78.3% of our patients, the sides of SIJ hypomobility and LDH were the same. After treatment, the patients showed statistically significant improvements in Gillet, standing flexion and sitting flexion tests in the 5th session and at 1-month follow-up (P ≤ 0.001). The findings also indicated 95% improvement in the results of the SIJ hypomobility tests after SMT.

Key Finding #4

Compared to common treatments for lumbar disc herniation (LDH), spinal manipulative therapy (SMT) is reported to be 37,000 to 148,000 times safer than nonsteroid anti-inflammatory drugs and 55,500 to 444,000 times safer than surgery.

Please provide your summary of the paper

The objective of this study was to evaluate the impact of spinal manipulative therapy (SMT) on pain, functional disability, and clinical test outcomes related to sacroiliac joint (SIJ) function and lumbar disc herniation (LDH) in patients with unilateral sacroiliac joint dysfunction and SIJ hypomobility. The study enrolled 20 participants aged 20 to 50 years with MRI-confirmed lumbar disc herniation and SIJ hypomobility. The treatment involved lumbar rotational manipulation and SIJ manipulation. Outcome measures included the Numerical Rating Scale (NRS) for back and leg pain, and the Oswestry Disability Index (ODI) for functional disability. Participants were also assessed using the straight leg raise (SLR) and slump tests to diagnose LDH, as well as the standing flexion, sitting flexion, and Gillet tests to identify SIJ hypomobility. The results demonstrated statistically significant improvements in back and leg pain and ODI scores. However, the study noted a lack of clinical significance based on the chosen outcome measures. Overall, as the authors suggest, SMT may enhance SIJ and lumbar vertebrae mobility and influence the surrounding musculature, which could explain the observed improvements in pain and functional ability.

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

According to the study results, no clinical significance was observed based on the Minimal Clinically Important Change (MCIC) for the Numerical Rating Scale (NRS) or the Oswestry Disability Index (ODI) at the fifth session or the one-month follow-up. The article highlights that spinal manipulative therapy (SMT) is a safer alternative to nonsteroidal anti-inflammatory drugs (NSAIDs) and surgery, as it neither worsened symptoms nor caused complications such as cauda equina syndrome, making adverse events extremely rare. The authors acknowledge several limitations in the study. To validate this approach in clinical practice, larger-scale studies and controlled trials are necessary. Future research should compare combined lumbar and SIJ manipulations to each technique performed independently, helping to determine whether the combination yields superior outcomes over isolated interventions.

Physiotherapy combined with dry needling among patients with chronic low back pain: Study protocol for a randomized controlled clinical trial

Article Full Title

Physiotherapy combined with dry needling among patients with chronic low back pain: Study protocol for a randomized controlled clinical trial

Author Names

Prodhania MS, Ahsan GU, Ali M.

Reviewer Name

Kayin Fails

Reviewer Affiliation(s)

Duke DPT

Paper Abstract

Chronic low back pain (CLBP) is an extremely common public health concern responsible for pain-related disability. CLBP is challenging to manage despite having a plethora of treatment options. Physiotherapy is a guideline-recommended treatment for CLBP. Furthermore, some forms of complementary medicines, such as dry needling, spinal manipulation, Tai Chi, and yoga are also recommended for CLBP treatment. We hypothesized that the combined treatment would be more effective when managing CLBP. Therefore, this randomized clinical trial aims to examine the impact of combined therapy of dry needling and physiotherapy compared to the treatment effect of only physiotherapy among patients with CLBP.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

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

Yes

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

Yes

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

Yes

Were study participants and providers blinded to treatment group assignment?

Yes

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)?

Yes

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

Cannot Determine, Not Reported, or Not Applicable

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

Cannot Determine, Not Reported, or Not Applicable

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

Yes

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

Yes

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

Yes

Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

Cannot Determine, Not Reported, or Not Applicable

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

Yes

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

Yes

Key Finding #1

There is limited evidence suggesting that the use of dry needling may offer some degree of effectiveness in reducing pain and improving pressure pain threshold among individuals experiencing musculoskeletal pain, within a timeframe ranging from immediate after the treatment to a 12-week follow-up period.

Key Finding #2

Compared to other physical therapy treatments, there seems to be no significant difference in functional outcomes.

Please provide your summary of the paper

The study is a randomized controlled trial aimed at assessing the effectiveness of physiotherapy combined with dry needling for patients suffering from chronic low back pain (CLBP). Participants aged 18 and older, who have experienced CLBP for at least three months, were divided into two groups: one receiving the combined therapy and the other receiving standard physiotherapy care. Pain severity and related symptoms will be evaluated at the beginning of the study and again at four, 12, and 24 weeks after treatment. The study found that there was no significant difference in the functional outcomes of the patients.

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

My clinical interpretation of this article is that there are many methods and modalities that can be used for manual therapy treatment. These results show that between the methods evaluated there was no one best method. Meaning that there are different ways of treating patients that will have a beneficial outcome. As a provider this shows me that the treatment modality should be tailored to the patient and what benefits them the most for their specific needs. Through practice, finding what techniques you as a provider like the most, with some good statistics can help you give the best treatment you can to aid in the progress of your patients.

Is the cadaveric model valid for examining orthopaedic manual therapy techniques? A cross-sectional comparative study in vivo and in vitro

Article Full Title

Is the cadaveric model valid for examining orthopaedic manual therapy techniques? A cross-sectional comparative study in vivo and in vitro

Author Names

López-de-Celis, C., Rodríguez-Sanz, J., Gassó-Villarejo, S., Bueno-Gracia, E., Canet-Vintró, M., Estébanez-de-Miguel, E.

Reviewer Name

Reghan Flores, SPT

Reviewer Affiliation(s)

Duke University School of Medicine – Doctor of Physical Therapy Division

Paper Abstract

Background: Cadaveric models are sometimes used to test the effect of manual techniques. We have not found any studies comparing the effect of tibiotarsal joint distraction on cadaveric models versus live models for clinical use. The aim was to compare the effect on tibiotarsal joint distraction movement when applying three force magnitudes of tibiotarsal axial traction technique force between a cadaveric model and volunteers. In addition, to compare the magnitude of force applied between the cadaveric model and volunteers. Finally, to assess the reliability of applying the same magnitude of force in three magnitudes of tibiotarsal axial traction force.

Methods: A cross-sectional comparative study was conducted. Sixty ankle joints were in open-packed position and three magnitudes of tibiotarsal axial traction technique force were applied. Tibiotarsal joint distraction movement was measured with ultrasound.

Findings: No differences were found in applied force or tibiotarsal joint distraction between volunteers and cadavers in each magnitude of force (p > 0.05). The application of the technique showed moderate reliability for detecting low forces in both models. For medium and high force, it showed good reliability in the in vitro model and excellent reliability in the live model.

Interpretation: The amount of distraction produced in the tibiotarsal joint was similar in volunteers and cadavers. The cadaveric model is a valid model for testing and investigating orthopaedic manual therapy techniques. The force applied was similar in the two models. Medium and high force detection showed good reliability, while low force showed moderate.

Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies

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

Yes

Was the study population clearly specified and defined?

Yes

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

Yes

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

Yes

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?

Yes

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

Yes

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

Yes

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

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

Yes

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

Key Finding #1

A cadaver, having undergone only one cryopreservative cycle, could be a valid model for orthopedic manual therapy technique testing due to the preservation of tissue integrity that mimics an in-vivo response.

Key Finding #2

The study did not find a statistical difference in tibiotarsal distraction application between the in-vivo volunteer and in-vitro cadaveric groups.

Key Finding #3

Of the three force intensities (low, medium, and high), the calculated difference between the volunteer and cadaver groups based on the amount of force applied for each intensity was not statistically significant.

Please provide your summary of the paper

In an effort to identify the efficacy of testing manual therapy techniques on cadaveric models, this cross-sectional analysis identified and compared both the difference of force grade and magnitude between the donated cadavers (in-vitro) and living volunteers (in-vivo). The technique evaluated was tibiotarsal axial traction, a method that utilizes a belt above the malleoli to stabilize the tibia and a tibiotarsal strap around the foot and ankle for the mobilization. For this study specifically, a mobilization belt with an attached dynamometer was fixated around the pelvis on the evaluating physical therapist and connected to the tibiotarsal strap; a second physical therapist managed a portable ultrasound machine to assess joint line separation, and a third evaluator served as recorder for the dynamometer force outputs for each manual therapy grade. In comparing the amount of tibiotarsal joint distraction with the above-listed technique at three different intensities, the authors identified no significant between-group difference in the amount of distraction reached at any of the given magnitudes nor was their significant difference in the applied force at each magnitude by the single physical therapist. The intra-rater reliability between the two trials given per magnitude of applied force was moderate-to-good among the cadavers and moderate-to-excellent among the volunteers; the greatest reliability was with high-force, which the authors attributed to the prominent feel of breaking through the capsular tension (“slack”) to end-range compared to middle and low force indicators. Overall, the study found reliable evidence that application of the tibiotarsal axial traction technique to cadavers was comparable to living volunteers, which paves the way for the potential use of cadavers to investigate orthopedic manual therapy techniques, especially for the ankle.

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

The research study appears to be of good quality for a cross-sectional comparison, utilizing a repeated measures design that ensured greater internal validity to the results and involved blinding the three evaluators to each other’s findings until after all subjects were assessed. All of the mobilizations were performed by the same physical therapist, who had 25 years of practice experience, and the authors ensured the tissue integrity of the cadaveric subjects was preserved via the research-backed method of a singular cycle of cryopreservation. In addition, the moderate-to-good intra-rater reliability between the two examined groups (in-vitro cadaver vs. in-vivo volunteer), combined with the finding of no statistical difference in joint distraction movement and force at each magnitude, indicates an evident similarity between the effect of tibiotarsal axial traction on a preserved cadaver compared to a living human.

Although the study did attempt to limit confounding variables via exclusion of both in-vivo and in-vitro limbs due to previous ankle surgery and/or sprain, the gap in mean age between the tested groups could be a limiting factor in this study’s validity due to the variation in tissue than occurs with aging. Furthermore, as cadavers cannot provide a self-history, external indications were relied upon for limb exclusion and may not have accounted for all previous ankle pathology among this study group. The sample size of thirty in-vitro and thirty in-vivo tibiotarsal joints should be considered as well, but it can be appreciated that the demographics outlined a relative balance of male and female participants. As this is a novel study, there are additional avenues to pursue with further research, such as the influence of previous ankle injury on results and if cadaver age has significant impact on repeatability of this study’s findings. However, the preliminary findings within this unexplored realm of manual therapy technique on the ankle joint indicate a strong potential for cadaveric models to serve at the forefront of manual therapy research due to the similar nature between the in-vitro and in-vivo subjects supported by this paper.

The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review

Article Full Title

The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review

Author Names

Trahan, J., Leger, E., Allen, M., Koebele, R., Yoffe, M., Simon, C., Alappattu, M., Figuers, C.

Reviewer Name

Greysee Floyd, SPT

Reviewer Affiliation(s)

Duke University Doctorate of Physical Therapy Program

Paper Abstract

Background: Pelvic floor physical therapy is a noninvasive option for relieving pain associated with dyspareunia, genital pain associated with sexual intercourse. Manual therapy is a clinical approach used by physical therapists to mobilize soft tissues, reduce pain, and improve function. To date, the systematic efficacy of manual therapy for treating dyspareunia has not been investigated.

Objective: To examine the efficacy of manual therapy in reducing pelvic pain among females with dyspareunia. Methods: A systematic literature search was conducted in MEDLINE, EMBASE, and CINAHL databases for articles published between June 1997 and June 2018. Articles were reviewed and selected on the basis of defined inclusion and exclusion criteria. The articles were assessed for quality using the PEDro and Modified Downs and Black scales.

Results: Three observational studies and 1 randomized clinical trial met inclusion criteria. The primary outcome measured was the pain subscale of the Female Sexual Function Index. All studies showed significant improvements in the pain domain of the Female Sexual Function Index (P < .5) corroborating manual therapy as a viable treatment in relieving pain associated with dyspareunia. However, the quality across studies ranged from poor to good.

Conclusions: Although these findings support the use of manual therapy for alleviating pain with intercourse, few studies exist to authenticate this claim. Moreover, the available studies were characterized by small sample sizes and were variable in methodological quality. More extensive research is needed to establish the efficacy of manual therapy for dyspareunia and the specific mechanisms by which manual therapy is beneficial.

Quality Assessment of Systematic Reviews and Meta-Analyses

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

Was publication bias assessed?

Yes

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

N/A

Key Finding #1

Pelvic pain associated with sexual intercourse can potentially be reduced with manual therapy treatment.

Key Finding #2

Women with sexual dysfunction and levator-related pelvic pain treated with manual therapy reported greater overall increased sexual function than with levator-directed trigger-point injections, but had a longer time-to-improvement.

Key Finding #3

The Wurn technique of releasing tension in pelvic musculature through soft tissue traction has demonstrated alleviation in dyspareunia and dysmenorrhea at 4 and 12 months follow-up posttreatment in patients with endometriosis.

Please provide your summary of the paper

This review analyzed 4 studies to determine the efficacy of manual therapy in treating in females with dyspareunia. Techniques used across studies included transvaginal massage, soft tissue traction at adhesion sites throughout subjects’ abdomen and pelvis, pelvic massage, trigger-point therapy, vaginal stretching, and compression maneuvers. The results of all studies indicated that manual therapy can be an effective, noninvasive treatment option for pain with intercourse by improving sexual dysfunction and pain intensity as shown by the Female Sexual Function Index; however, it cannot be determined which manual therapy technique nor treatment time is most effective. The literature currently available is limited and lacking high-quality evidence due to small sample sizes and inconsistent methodological quality. In order to establish clinical practice guidelines and standardization of treatment among pelvic health physical therapists, more research will need to be done at a higher standard to fully support the use of manual therapy in patients with dyspareunia.

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

Physical therapists specializing in and treating populations with dyspareunia should consider manual therapy as one of many treatment options. The findings support patient-centered care as no method was found to be the most effective, emphasizing the importance of using a technique that matches each patient’s needs and preferences. There are external soft tissue mobilization methods as well as tools for self-administration of internal techniques to optimize patient comfort level. While many patients have found manual therapy to be helpful in reducing pain, the available research is still lacking and physical therapists should use their individual clinical reasoning to determine whether it is appropriate for their patient. The results of this review can be implemented by receiving specialized training in these techniques, patient education of manual therapy, and collaboration with other healthcare professionals involved in the treatment of dyspareunia, such as gynecologists and psychologists. The need for continued research is critical in order to help women with this challenging condition improve their sexual function and quality of life.

Manual therapy and early return to sport in football players with adductor-related groin pain: A prospective case series

Article Full Title

Manual therapy and early return to sport in football players with adductor-related groin pain: A prospective case series

Author Names

Igor Tak PhD, MScPTa,b, Rob Langhout MMT PTb,c, Bas Bertrand MScPTd , Maarten Barendrecht MPTSe , Janine Stubbe PhDf , Gino KerkhoGs PhD, MDb,g, and Adam Weir PhD, MBBSc,h

Reviewer Name

Chad Fortin

Reviewer Affiliation(s)

Duke University School of Physical Therapy

Paper Abstract

Objectives: To study the clinical course including return to sport success rates of football players with adductor-related groin pain (ARGP) after manual therapy of the adductor muscles. Design: Prospective case series. Methods: Thirty-four football players with ARGP with median pre-injury Tegner scores of 9 (IQR 25–75: 9–9) were treated with manual therapy of the adductor muscles. Main outcome measures were numeric pain rating scale (NPRS), Hip and Groin Outcome Score (HAGOS) and global perceived eGect (GPE) for treatment and patient satisfaction at 2, 6 and 12 weeks. Return to sport was documented. Results: Pain during (NPRS 7 (6–8) and after (NPRS 8 (6–8) sports decreased to NPRS 1 (0.2–3) and 1 (0.8–3), respectively (p < 0.001). Within 2 weeks 82% of the players returned to pre-injury playing levels with improved (p < 0.001) HAGOS subscale scores. Eighty-five percent reported clinically relevant improvement, 82% reported to be satisfied. At 12 weeks, 88% had returned to preinjury playing levels. HAGOS showed symptoms were still present. Conclusion: Early return to sport seems possible and safe after manual therapy of the adductor muscles in football players with ARGP in the short term. While the majority of injured football players return to sport within two weeks, caution is advised regarding eGectiveness as hip and groin symptoms were still present and no control groups were available.

NIH Risk of Bias Tool:

Quality Assessment Tool for Case Series Studies

1. Was the study question or objective clearly stated? Yes

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

3. Were the cases consecutive? No

4. Were the subjects comparable? Yes

5. Was the intervention clearly described? Yes

6. Were the outcome measures clearly defined, valid, reliable, and implemented consistently across all study participants? No

7. Was the length of follow-up adequate? Yes

8. Were the statistical methods well-described? No

9. Were the results well-described? No

Key Finding #1

Pain decreased after 2 weeks following implementation of manual therapy.

Key Finding #2

Manual manipulation of adductors is promising for reduction of pain, and clinical improvement among football players.

Key Finding #3

82% of football players with adductor-related groin pain returned to football at preinjury levels within two weeks.

Key Finding #4

Manual therapy of adductors is safe for return to sport protocols

Please provide your summary of the paper

This paper analyzes the eGectiveness of manual therapy in managing adductor-related groin pain among football players. It addresses the concern surrounding the capacity for functional improvement among football players with adductor-related groin pain, as well as their ability to return to sport. Through the examination of this case series, the clinical utility of manual therapy techniques as they pertain to this specialized group can be utilized to create positive outcomes of decreasing pain and accelerating a return to previous function in sport.

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 provides a strong argument in favor of manual therapy and its use among football players with adductor-related groin pain. In clinical settings where athletes are being treated with a similar pain presentation as these subjects, the use of manual therapy should not be overlooked. Moreover, it’s integration in their plan of care should be encouraged, as those who received manual therapy demonstrated better outcomes than those who did not. Previous notion that manual therapy could prove to be unsafe for this population should be questioned, and more clinicians should include manual therapy in their return-to-sport protocols.

Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo

Article Full Title

Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo

Author Names

Heymann, W

Reviewer Name

Max Francisco- Duke DPT SPT

Reviewer Affiliation(s)

Duke DPT class of 2026

Paper Abstract

Study Design – A randomized, double-blinded, placebo-controlled, parallel trial with 3 arms.

Objective – To investigate in acute nonspecific low back pain (LBP) the effectiveness of spinal high-velocity low-amplitude (HVLA) manipulation compared with the nonsteroidal anti-inflammatory drug diclofenac and with placebo.

Summary of Background Data – LBP is an important economical factor in all industrialized countries. Few studies have evaluated the effectiveness of spinal manipulation in comparison to nonsteroidal anti-inflammatory drugs or placebo regarding satisfaction and function of the patient, off-work time, and rescue medication.

Methods – A total of 101 patients with acute LBP (for <48 hr) were recruited from 5 outpatient practices, exclusion criteria were numerous and strict. The subjects were randomized to 3 groups: (1) spinal manipulation and placebo-diclofenac; (2) sham manipulation and diclofenac; (3) sham manipulation and placebo-diclofenac. Outcomes registered by a second and blinded investigator included self-rated physical disability, function (SF-12), off-work time, and rescue medication between baseline and 12 weeks after randomization.

Results – Thirty-seven subjects received spinal manipulation, 38 diclofenac, and 25 no active treatment. The placebo group with a high number of dropouts for unsustainable pain was closed praecox. Comparing the 2 active arms with the placebo group the intervention groups were significantly superior to the control group. Ninety subjects were analyzed in the collective intention to treat. Comparing the 2 intervention groups, the manipulation group was significantly better than the diclofenac group (Mann-Whitney test: P = 0.0134). No adverse effects or harm was registered.

Conclusion – In a subgroup of patients with acute nonspecific LBP, spinal manipulation was significantly better than nonsteroidal anti-inflammatory drug diclofenac and clinically superior to placebo.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

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

Yes

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

Yes

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

Yes

Were study participants and providers blinded to treatment group assignment?

Yes

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

Yes

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

Yes

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

Yes

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

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)?

Yes

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

Yes

Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

Cannot Determine, Not Reported, or Not Applicable

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

Yes

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

Yes

Key Finding #1

The subjects with spinal manipulation showed a faster and quantitatively more distinct reduction in the Roland-Morris Disability Score (RMS). The mean values (± SD) of the reduction on the RMS score versus pretreatment values were 7.71 ± 4.88 after spinal manipulation and 4.75 ± 4.93 in the NSAID group.

Key Finding #2

Subjects noticed a faster and quantitatively more distinct reduction in this subjective estimation of pain after manipulation. A similar observation was made when comparing the somatic part of the SF-12 inventory, indicating that the subjects experienced better quality of life after the spinal manipulation when compared to the group who tool the NSAID diclofenac.

Key Finding #3

The method of randomization as well as the blinding procedure were very efficient and can be generalized. The chosen sham manipulation in this trial is related to the real manipulation. Other trials to compare manual manipulation techniques should include other sham manipulations.

Please provide your summary of the paper

This paper documents a very interesting randomized controlled study that analyzes the difference in 3 groups, a group who received spinal manipulations therapy, a group that received the NSAID, diclofenac, a placebo group in treating acute non-specific low back pain. This study was a double blind randomized controlled trial where the participants in the SMT group received manual therapy as well as a placebo pill, the participants in the NSAID group received diclofenac and “sham” manual therapy maneuvers, and the participants in the placebo group received a placebo pill and “sham” manual therapy techniques. This is how the researchers were able to ensure that any differences between the three groups was strictly due to the manipulation. The participants were assessed for their pain 3 days after the initial treatment and then 7 to 9 days after the original treatment. The paper shows that out of the 35 participants in the manipulation group, 3 days after the treatment, 7 people had complete relief, 23 had improved symptoms, 4 people had no change, and 1 person’s symptoms worsened. Out of the 37 people in the diclofenac group, 3 days after the treatment, 3 people had complete relief, 17 had improved symptoms, 13 people had no change, and 4 person’s symptoms worsened. Figure 6B in the paper shows that out of the 35 participants in the manipulation group, 7 to 9 days after the treatment, 19 people had complete relief, 10 had improved symptoms, 6 people had no change, and no one has their symptoms worsened. Out of the 37 people in the diclofenac group, 7 to 9 days after the treatment, 8 people had complete relief, 13 had improved symptoms, 9 people had no change, and 7 person’s symptoms worsened. The researchers ruled there to be a significant difference in the improvement of symptoms between the SMT and the NSAID group. Additionally, the participants were assessed using the Roland-Morris Disability Questionnaire and the participants global expression of change. The researchers found a significant difference in the participant’s reported quality of life and the improvement on the RMDQ for the SMT 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 paper suggests that spinal manipulation therapy can and should be a viable treatment for patients with acute non-specific low back pain. Additionally, this study was designed in a way that reduces both participant and tester bias and seems to be a valid study that is easily repeatable. Knowledge of the benefits that spinal manipulation therapy can have will allow me, as a clinician, to best serve my patients by integrating evidence based manual therapy techniques into my treatment plans. By having the ability to administer spinal manipulations, I can provide the patients I see with a viable, non-pharmacological way to treat their acute non-specific low back pain.

Manual Therapy Provided by Physical Therapists in a Hospital-Based Setting: A Retrospective Analysis

Article Full Title

Manual Therapy Provided by Physical Therapists in a Hospital-Based Setting: A Retrospective Analysis

Author Names

Cook C, Cook A, Worrell T

Reviewer Name

Annabelle Frantz, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Program

Paper Abstract

Objective The purpose of this study was to compare outcomes, complications, and hospital disposition in a cohort of patients hospitalized for low back pain who receive physical therapist (PT)–administered manual therapy (mobilization and manipulation) vs those who do not receive manual therapy. Methods The study was a retrospective data collection that used the Nationwide Inpatient Sample. Seventy-five patients hospitalized with low back pain who receive PT-administered manual therapy were matched using specific covariates with patients with low back who did not receive manual therapy. Bivariate analyses and regression modeling were used to determine comparisons between the 2 groups. Results Findings indicated that patients who received PT manual therapy had significantly longer lengths of hospital stay ( P < .01) and had significantly higher inflation-adjusted costs of care ( P < .01). After regression modeling and adjustments for covariates, findings for length of stay were still higher in the PT manual therapy group ( P < .01), but costs were significantly lower for this group ( P < .01). There were minimal findings of complications. Conclusions Of 106 340 patients admitted for low back pain originally queried, only 75 patients (0.07%) received manual therapy, a markedly small number of patients. Outcomes may be reflective of the low effect size of manual therapy in a hospital setting or the inability to control for referral and hospital care patterns, thus disallowing appropriate matching.

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?

Yes

Was the study population clearly specified and defined?

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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?

Yes

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

Yes

Key Finding #1

This study found only 75 instances of documented manual therapy use in a hospital-based setting by physical therapists in a 17-year span for patients with low back pain.

Key Finding #2

Patients who receive physical therapist–administered manual therapy in a hospital-based setting who have been diagnosed with low back pain have significantly lower hospital charges.

Key Finding #3

Patients who receive physical therapist–administered manual therapy in a hospital-based setting who have been diagnosed with low back pain have significantly longer length of stays.

Key Finding #4

Of 106,340 patients admitted for low back pain originally queried, only 75 patients (0.07%) received manual therapy, a markedly small number of patients

Please provide your summary of the paper

This study looked at the use of manual physical therapy with individuals admitted in the acute care setting with mechanical low back pain. The analysis separated patients by those who received manual therapy and those who did not. The two groups were adjusted for covariates. The author notes it was challenging to understand fully who received manual therapy and who did not. While those who received manual therapy had longer hospital stays and lower costs, the patients who received manual therapy only made up 0.7% of those included in the study, indicating a need for further exploration. It is also important to note that length of stay in the hospital is influenced by many factors, not just physical therapy intervention and efficacy. Some limitations of this study are that it is not a randomized controlled trial, manual therapy may have been underreported, and there are likely still covariates that are at play.

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 may impact clinical practice by encouraging a further exploration of manual therapy in the hospital setting. The lack of specific documentation around manual therapy in the hospital setting that was observed in the study makes it challenging to understand what is being implemented. This begs for more investigation and understanding of when and how to use manual therapy techniques on those with low back pain and other musculoskeletal diagnoses in the hospital setting. The results can be implemented by taking careful consideration and speaking with the whole care team before using manual therapy as an intervention since some outcomes were negative and some were positive.

The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbar Disc Herniation Patients: A Single Blinded Randomized Clinical Trial

Article Full Title

The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbar Disc Herniation Patients: A Single Blinded Randomized Clinical Trial

Author Names

Taşkaya, B., Taşkent, İ., Çakıllı, M., Yılmaz, Ö.

Reviewer Name

Abby Frazier, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Background: This study aimed to investigate the e&ect of manual therapy on pain, kinesiophobia, pain catastrophizing, anxiety, depression, and quality of life in patients with lumbar disc herniation (LDH). Methods: The study included 32 LDH patients. Patients were divided into the Manual therapy group (MTG—age 39.81 ± 9.45 years) and the Exercise group (EG—age 38.31 ± 9.21 years) by sealed envelope randomization. Patients were evaluated pre-study, post-study, and after a 3-month period using the McGill–Melzack Pain Questionnaire (MMPQ), Hospital Anxiety and Depression Scale (HADS), Tampa Kinesiophobia Scale (TKS), Pain Catastrophizing Scale (PCS) and Nottingham Health Profile (NSP). The exercise group received a total of ten sessions of stabilization exercises and sham spinal mobilization in five weeks, two sessions per week. In addition to the stabilization exercises, mobilization applications including Anterior-Posterior Lumbar Spinal Mobilization, Lumbar Spinal Rotational Mobilization, and Joint Mobilization in Lumbar Flexion Position, were applied to the manual therapy group. Results: It was found that the HADS and TKS values decreased in the MTG group compared to the pre-treatment period (p < 0.05), while there was no di&erence between these values in the EG group (p > 0.05). There was a statistically significant di&erence in the MMPQ, PCS, and NHP values after treatment in both the MTG and EG groups (p < 0.05). Conclusions: It was found that manual therapy had positive e&ects on psychological factors such as pain, kinesiophobia, pain catastrophizing, anxiety, depression, and quality of life in patients with LDH.

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? No

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? Cannot Determine, Not Reported, or Not Applicable

10. Were other interventions avoided or similar in the groups (e.g., similar background treatments)? Cannot Determine, Not Reported, or Not Applicable

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? No

Key Finding #1

Manual therapy coupled with stabilization exercises resulted in improvements in kinesiophobia, anxiety, and depression in participants with lumbar disc herniation.

Key Finding #2

Stabilization exercises, with and without the addition of manual therapy, resulted in improved pain, quality of life, and pain catastrophizing in participants with lumbar disc herniation.

Please provide your summary of the paper

Lumbar disc herniation (LDH) is a condition of high incidence that impacts various aspects of an individual’s life. Low back pain caused by LDH not only has a negative e&ect on the physical functioning of an individual but also negatively impacts psychological and social factors, making it a condition requiring a biopsychosocial approach to treatment. This study aimed to determine the effect of manual therapy on psychological factors and quality of life in patients with LDH. Participants were randomized into two groups, a manual therapy group (MTG) and an exercise group (EG). The MTG underwent stabilization exercises and spinal mobilizations, while the EG participated in stabilization exercises and sham spinal mobilizations. The outcomes assessed were the McGill-Melzack Pain Questionnaire (MMPG), the Hospital Anxiety and Depression Scale (HADS), the Tampa Kinesiophobia Scale (TKS), the Pain Catastrophizing Scale (PCS), and the Nottingham Health Profile (NHP). Each outcome was assessed three times, pre-treatment, posttreatment, and a three-month follow-up. The results of the study found a significant decrease in scores on the HADS and TKS in the MTG only and a significant decrease in scores on the MMPG, PCS, and NHP for both the MTG and the EG. In conclusion, this study provides evidence that the implementation of manual therapy in patients with LDH has a positive impact on pain, psychological factors, and quality of life.

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 provides evidence of the broader benefits of manual therapy beyond causing improvements in function and pain. It is important to note that the results of this study were due to the implementation of both manual therapy and exercise. In the clinic, it would be necessary to consider manual therapy in conjunction with physical therapy exercises to achieve results similar to those seen in the study, instead of relying on manual treatment alone. LDH is prevalent, and the chronic low back pain it results in is multifactorial, meaning there is a need to consider factors outside of the biological and physical causes and attributes of the condition. Due to this complex nature, the findings of this study are important for physical therapists to understand and consider in the clinic as they utilize a biopsychosocial approach to the treatment of patients with low back pain, specifically caused by LDH.

An Evaluation of the effectiveness of Ibuprofen and Manual Therapy in Young Women with Dysmenorrhea- A Pilot Study

Article Full Title

An Evaluation of the effectiveness of Ibuprofen and Manual Therapy in Young Women with Dysmenorrhea- A Pilot Study

Author Names

Barcikowska,Z., Rajkowska-Labon,E., Grzybowska, M., Hansdorfer-Korzoon, R., Waź, P., Zorena, K.

Reviewer Name

Sarah Freeman Bachelors of Psychology

Reviewer Affiliation(s)

Second year Doctorate of Physical Therapy student at Duke University. University of Georgia Franklin College of Arts and Sciences Alumn.

Paper Abstract

The aim of the study was to evaluate the effect of manual therapy and the use of ibuprofen on the severity of dysmenorrhea and changes in the level of sex hormones in young women with dysmenorrhea. Material and methods: The study included six women, aged 22 ± 2 years, with primary dysmenorrhea (PD). A physiotherapist examined the tenderness and flexibility of the muscles. The patients were subjected to a gynecological and physiotherapeutic examination; the concentrations of progesterone and 17-beta-estradiol were also determined. In subgroup A (n = 3), manual therapy was performed 3 x 45 min; in subgroup B (n = 3), the patients received ibuprofen 3 x 400 mg/day. Results: In subgroup A, all patients showed a decrease in the level of progesterone and an increase in the concentration of estradiol. In subgroup B, the concentration of progesterone and 17-beta estradiol decreased in two subjects. In subgroup A, manual therapy reduced the severity of headache, back pain, diarrhea, fatigue, and PMS. In subgroup B, the use of ibuprofen only alleviated back pain and fatigue. Moreover, in subgroup A, after the application of manual therapy, improvement in flexibility and pain relief of the examined muscles was demonstrated. On the other hand, in subgroup B, no improvement in flexibility or reduction in muscle soreness was found in patients who took ibuprofen. Conclusions: Manual therapy may reduce menstrual pain in women with dysmenorrhea. However, the results need to be confirmed in studies conducted on a larger group of patients with dysmenorrhea.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

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

Yes

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

Yes

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

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?

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)?

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

Cannot Determine, Not Reported, or Not Applicable

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

Yes

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

Yes

Key Finding #1

All of the patients that were subjected to manual therapy demonstrated improvements in back pain and soreness/ tightness in the quadratus lumborum muscles, with some patients also experiencing relief and increased flexibility in other muscles including the TFL, hamstrings, piriformis and iliiopsoas. The patients who only received ibuprofen did not experience the same muscle tension releases, though most still reported some alleviation of pain. Back pain was alleviated in all patients receiving manual therapy, and only in one patient receiving ibuprofen treatment.

Key Finding #2

2/3 patients in the manual therapy-treated group experienced a shorter duration of menstruation pain as compared to no individuals in the ibuprofen group having a shortened duration of experienced pain.

Key Finding #3

In all of the patients receiving manual therapy, progesterone levels were decreased in comparison to their pre-treatment levels. In the ibuprofen group, only 2/3 patients were found to have decreased levels of progesterone as compared to their pre-treatment levels.

Please provide your summary of the paper

The results of the study demonstrated that manual therapy was comparable, and in most cases, more beneficial than Ibuprofen in treating muscle tightness and back pain, and in decreasing the amount of time menstruation pain was experienced. The study utilized established measurements of range of motion, palpation, and blood draws to create baseline measurements to compare with the final results. The manual therapy group received 3, 45 minute treatments involving mobilization of the breathing diaphragm, post-isometric relaxation, and trigger point therapy, and the results of these treatments were compared to the ibuprofen group who took 3 doses of 400mg daily. All of the patients within the manual therapy group experienced alleviation of menstruation pain and muscle soreness, and a decreased menstruation pain duration. In the ibuprofen group, 2 /3 of the individuals experienced alleviation of pain, but they did not receive any changes in muscle tightness or decrease in overall pain duration. The manual therapy individuals also showed a decrease in progesterone levels, while this finding was not unanimous for the ibuprofen group. The limitations of this study were that there was no strictly untreated control group, and that the sample size of the study was small, making it hard to generalize to a larger population.

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

The results of this study demonstrated that manual therapy helped improve muscle soreness, flexibility, and overall pain relief related to dysmenorrhea in young females, and had a overall greater pain-relieving impact than ibuprofen. Although the data showed significant improvements in subjectively reported levels of back pain, pain duration, and objective flexibility, the exclusion criteria regarding the participants make this study less generalizable to the greater female population due to the exclusion of those with irregular cycles, those on hormonal contraceptives, and those who have carried children. This study could be expanded to incorporate a larger population if future trials included women who have carried children, or women who have irregular cycles or reproductive diseases, as these women are particularly likely to experience dysmenorrhea. This study could be implemented and utilized to encourage physicians to refer patients to physical therapists for menstruation-related pain alleviation instead of automatically turning to medications for relief, helping to encourage physician-therapist relationships and decrease dependency on Nsaids for pain relief. This study could also help broaden the type of patients and patient clinical presentations that physical therapists encounter.

Immediate Effect of Lumbar Mobilization on Activity of Erector Spinae and Lumbar Multifidus Muscles

Article Full Title

Immediate Effect of Lumbar Mobilization on Activity of Erector Spinae and Lumbar Multifidus Muscles

Author Names

Mehyar, F; Santos, M; Wilson, S; Staggs, V; Sharma, N

Reviewer Name

Jessica Fullerton, SPT

Reviewer Affiliation(s)

Duke University, Doctor of Physical Therapy Program

Paper Abstract

The purpose of this study was to investigate the effect of grade IV lumbar mobilization on the activity/ contraction of erector spinae (ES) and lumbar multifidus (LM) muscles in healthy people. A randomized, repeated-measures design was used. Sixteen healthy subjects attended 3 testing sessions with a different intervention in each session (no intervention, grade IV central lumbar mobilization at L4, and placebo/ light touch). Lying in a prone position, subjects lifted a light weight with their right arm while ultrasound images of LM and surface electromyography signals of ES were captured before and immediately after application of the intervention in the session. The contraction of LM was calculated from US images, and the root mean square was calculated from the electromyography signals of ES and used as outcome measures. A significant difference was found in LM contraction between the placebo and mobilization intervention (difference = 0.04, P = .02). There was no difference for the root mean square of electromyography signals between the interventions. The significant difference in LM contraction was small and may not have clinical significance. Lumbar mobilization did not change the activity of ES in healthy people. Future studies with larger samples are needed to confirm our findings and to investigate the effect of mobilization on back muscles in people with low back pain. (J Chiropr Med 2017;16:271-278)

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)?

Cannot Determine, Not Reported, or Not Applicable

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?

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

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?

Cannot Determine, Not Reported, or Not Applicable

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

Cannot Determine, Not Reported, or Not Applicable

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

Yes

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

Yes

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

Yes

12. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

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

In young, healthy, active individuals, there was a statistically significant difference in lumbar multifidus contraction when grade IV lumbar mobilizations were applied; this difference was small and may not be clinically significant.

Key Finding #2

There was no significant difference in muscle contraction of the erector spinae muscle when grade IV mobilizations were implemented.

Key Finding #3

Lumbar mobilizations have the potential to increase lumbar strength and decrease risk of LBP in healthy subjects due to the results of the study that grade IV lumbar mobilizations can increase lumbar multifidus contraction.

Key Finding #4

Outcomes were measured using a submaximal arm lift test with ultrasound imaging and surface electromyography measuring muscle contraction.

Please provide your summary of the paper

While the study showed there was a significant difference in lumbar multifidus contraction, this was small and may not be clinically significant while the erector spinae had no difference in contraction. Since the study used individuals without LBP, I thought it was limited in the understanding since the LM and ES muscles should not exhibit any weakness or loss of contraction in the absence of pain. Furthermore, with the lack of testing patients with LBP, it appeared to me that generalizations were made on strengthening these specific muscles to carry over to patients who exhibit LBP; this could have been made more specific if participants with LBP were included in the study with non-LBP individuals. I thought this study would have benefited from using a larger sample size which could include older or less active individuals since this studied was biased towards younger, active individuals. Even more so, with individuals being healthy and active, a submaximal contraction of an arm lift most likely did not present participants with much of challenge. Varying exercises throughout the study might have shown a greater increase in muscle contraction due to a greater challenge proposed along with incorporating exercises participants might do throughout the day or current workout regime. Another inquiry I had included the possible effects of other grades of lumbar mobilizations on participants with LBP as grade IV mobilizations appeared to be the primary focus. With the focus of the study only being on young, healthy and active participants, the varying effects other grades of mobilizations might have on ES and LM muscles in participants with LBP was omitted.

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

Further research and evidence are needed to determine whether the effect of lumbar mobilizations increase muscle activation in the prevention and treatment of LBP. Despite this, there was a clinically significant increase in lumbar multifidus contraction between the placebo and the mobilization. Since the lumbar multifidus muscle provides stabilization to the spine, increased activation of this can help decrease LBP. Grade IV mobilizations can be included in a treatment regime in physical therapy clinics for the LBP population to increase LM activation; this was only tested in young, healthy, active individuals. Future studies should include older and less active participants to determine the difference since LBP is prominent across multiple populations; this can help determine the clinical implication for more populations not tested. While more research needs to be done to confirm results from this study, including lumbar mobilizations in physical therapy for patients with LBP may be beneficial for pain management as the study refers to previous studies along with increase LM activation as shown through this study. This can impact clinical care by improving lumbar stabilization from the LM muscle with implementation of grade IV mobilizations prior to exercise. This study also shows that the implementation of grade IV mobilizations can be used as a preventative measure when decreasing the risk of LBP which can be used in healthy populations in the physical therapy clinic prior to exercising.

Do Participants With Low Back Pain Who Respond to Spinal Manipulative Therapy Differ Biomechanically from Nonresponders, Untreated Controls or Asymptomatic Controls?

Article Full Title

Do Participants With Low Back Pain Who Respond to Spinal Manipulative Therapy Differ Biomechanically from Nonresponders, Untreated Controls or Asymptomatic Controls?

Author Names

Wont, Arnold Y. L. PT, Mphil, PhD; Parent, Eric C. PT, PhD; Dhillon, Sukhvinder S MB, ChB, CCST; Prasad, Narasimha PhD; Kawchuk, Gregory N. DC, PhD

Reviewer Name

Maria Gonzalez-Alvarez, SPT

Reviewer Affiliation(s)

Duke University, School of Medicine, Doctor of Physical Therapy

Paper Abstract

Study Design. Nonrandomized controlled study. Objective. To determine whether patients with low back pain (LBP) who respond to spinal manipulative therapy (SMT) differ biomechanically from nonresponders, untreated controls or asymptomatic controls. Summary of Background Data. Some but not all patients with LBP report improvement in function after SMT. When compared with nonresponders, studies suggest that SMT responders demonstrate significant changes in spinal stiffness, muscle contraction, and disc diffusion. Unfortunately, the significance of these observations remains uncertain given methodological differences between studies including a lack of controls. Methods. Participants with LBP and asymptomatic controls attended 3 sessions for 7 days. On sessions 1 and 2, participants with LBP received SMT (+LBP/+SMT, n = 32) whereas asymptomatic controls did not (−LBP/−SMT, n = 57). In these sessions, spinal stiffness and multifidus thickness ratios were obtained before and after SMT and on day 7. Apparent diffusion coefficients from lumbar discs were obtained from +LBP/+SMT participants before and after SMT on session 1 and from an LBP control group that did not receive SMT (+LBP/−SMT, n = 16). +LBP/+SMT participants were dichotomized as responders/nonresponders on the basis of self-reported disability on day 7. A repeated measures analysis of covariance was used to compare apparent diffusion coefficients among responders, nonresponders, and +LBP/-SMT subjects, as well as spinal stiffness or multifidus thickness ratio among responders, nonresponders, and −LBP/−SMT subjects. Results. After the first SMT, SMT responders displayed statistically significant decreases in spinal stiffness and increases in multifidus thickness ratio sustained for more than 7 days; these findings were not observed in other groups. Similarly, only SMT responders displayed significant post-SMT improvement in apparent diffusion coefficients. Conclusion. Those reporting post-SMT improvement in disability demonstrated simultaneous changes between self-reported and objective measures of spinal function. This coherence did not exist for asymptomatic controls or no-treatment controls. These data imply that SMT impacts biomechanical characteristics within SMT responders not present in all patients with LBP. This work provides a foundation to investigate the heterogeneous nature of LBP, mechanisms underlying differential therapeutic response, and the biomechanical and imaging characteristics defining responders at baseline. Level of Evidence: 3

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 No

2. Was the method of randomization adequate (i.e., use of randomly generated assignment)? Cannot Determine, Not Reported, or Not Applicable

3. Was the treatment allocation concealed (so that assignments could not be predicted)? Cannot Determine, Not Reported, or Not Applicable

4. Were study participants and providers blinded to treatment group assignment? No

5. Were the people assessing the outcomes blinded to the participants’ group assignments? Cannot Determine, Not Reported, or Not Applicable

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)? Cannot Determine, Not Reported, or Not Applicable

7. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment? Cannot Determine, Not Reported, or Not Applicable

8. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower? Cannot Determine, Not Reported, or Not Applicable

9. Was there high adherence to the intervention protocols for each treatment group? Cannot Determine, Not Reported, or Not Applicable

10. Were other interventions avoided or similar in the groups (e.g., similar background treatments)? Cannot Determine, Not Reported, or Not Applicable

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

12. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power? No

13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)? Cannot Determine, Not Reported, or Not Applicable

14. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis? Cannot Determine, Not Reported, or Not Applicable

Key Finding #1

Spinal Stiffness and Multifidus Muscle Thickness: SMT responders showed significant decrease in spinal stiffness and increase in multifidus muscle thickness ratio after the first SMT session. These changes remained for over 7 days and were not found in either the nonresponders or asymptomatic controls.

Key Finding #2

Intervertebral Disc Diffusion: SMT responders show significant improvement in apparent diffusion coefficients (ADC) of lumbar discs post-SMT. This is an indication of enhanced disc diffusion. This improvement was not found in nonresponders and untreated LBP controls.

Key Finding #3

No Significant Changes in Untreated Controls: Those in the untreated control group were found to have no significant changes with regards to spinal stiffness, multifidus muscle thickness or disc diffusion. This is an indication that changes seen in the SMT groups were most likely due to intervention itself and not due to a natural progression nor due to other factors.

Please provide your summary of the paper

The goal of this study was to investigate the effects of spinal manipulative therapy (SMT) on individuals with low back pain (LBP). They assessed for changes in biomechanical outcomes like, spinal stiffness, multifidus muscle thickness and disc diffusion. They placed participants in four different groups: responders to SMT, nonresponders, untreated controls, and asymptomatic controls. The study found that some but not all participants with LBP showed improvement in function after SMT. When compared to nonresponders, SMT responders showed significant changes in spinal stiffness, muscle thickness, and disc diffusion. The untreated control group were found to have no significant changes in spinal stiffness, muscle thickness, or disc diffusion. This further proves that the effects seen in the SMT groups were most likely due to the intervention itself. In conclusion, the study suggests that SMT may have beneficial effects on spinal stiffness, multifidus thickness, and disc diffusion. This then may offer an explanation on its effectiveness in treating LBP.

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

The study addressed a clinical question regarding the biomechanical differences among individuals with low back pain (LBP) and their response to spinal manipulative therapy (SMT). The study provided a well-rounded analysis as it included four groups-responders, nonresponders, untreated controls and asymptomatic controls. The study found that some but not all participants with LBP showed improvement in function after SMT. When compared to nonresponders, SMT responders showed significant changes in spinal stiffness, muscle thickness, and disc diffusion. Though the study did find differences between groups, the significance is uncertain due to the methodological differences between studies. The study focuses on spinal stiffness, muscle thickness and disc diffusion as the biomechanical parameters. These measures may not fully account for all relevant biomechanical changes that occur with LBP or SMT response. In choosing to perform a nonrandomized study, it may introduce selection bias. This study does provide a foundation to further investigate the nature of LBP and the mechanisms underlying differential therapeutic responses.

Immediate Effects of Spinal Manipulative Therapy on the Performance of Elite Brazilian Soccer Players: A Pilot Randomized Controlled Trial With an Internally Validated Sham Treatment

Article Full Title

Immediate Effects of Spinal Manipulative Therapy on the Performance of Elite Brazilian Soccer Players: A Pilot Randomized Controlled Trial With an Internally Validated Sham Treatment

Author Names

Botelho, M. et al

Reviewer Name

Devin Hage

Reviewer Affiliation(s)

DPT student at Duke University

Paper Abstract

Objective: The purpose of this study was to assess the feasibility of the procedures’ routine, the recruiting rate, the presence of any significant detrimental impact on the players’ training routine, and the sham efficacy in achieving blinding. Methods: A parallel randomized controlled clinical trial was performed with 20 elite soccer players who were randomly assigned to 1 of 2 groups: spinal manipulative therapy (SMT) and sham SMT. All players were from the same team, were injury free, and were naive to SMT. Measured outcome tests (30-m sprint run with a 10-m split and change of direction [COD] test) were performed at the same time by all participants immediately before and after interventions. Photocell devices were used for data acquisition. Results: Twenty participants were analyzed (10 in each group). There were no changes to the sprint (10 m and 30 m) and COD test results immediately after either of the interventions. All participants in both groups (SMT and sham SMT) answered “yes” to a question after the intervention asking if they were treated by SMT. No adverse effects or training routine impairment were reported. Conclusion: This pilot study protocol showed it was an appropriate design for a confirmatory clinical trial. The study had minimal effect on the team training routine, and the recruitment rate was excellent. The proposed sham SMT strategy was successful in blinding the players. In this sample, SMT did not have any immediate effect on the performance of these elite soccer players, as measured by 10- and 30-m sprint times and COD sprint times. (J Chiropr Med 2022;21;270-279)

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Yes

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

Cannot Determine, Not Reported, or Not Applicable

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

Yes

13. 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

Following spinal manipulation, there was not immediate change in the performance of the soccer players when tested on their 10 and 30 meter sprint times, nor their change of direction test times

Key Finding #2

It is very practical to include a control (sham) group when performing a randomized study to perform spinal manipulations to preserve blinding of participants and researchers.

Key Finding #3

There was no negative association with slower outcome measure times when spinal manipulations were performed.

Key Finding #4

This pilot study proved effective to contain a sham group for future studies to analyze the effects of SMT whether it be a larger sample size, different elite performance patient populations etc.

Please provide your summary of the paper

This paper served as a confirmatory clinical trial to assess the effectiveness of spinal manipulation therapy (SMT) on an elite male Brazilian soccer team while using a sham-group to confirm internal validity of such method to be used for future studies. Participants were recruited from the same soccer team and were medically deemed appropriate by a physician to receive SMT. Participants underwent their normal training schedule leading up to the intervention, consisting of 5 days a week of practice ranging from 120 to 180 minutes including soccer-specific training, strength training and conditioning. It was also noted, part of the inclusion criteria required all participants to have no previous experience of SMT. Participant outcome measures included a time test on a 10 and 30 meter sprint and a change of direction test following a standardized warm-up. Next, participants were randomly assigned to the SMT group and the sham-SMT group, 10 in each. The SMT group received manipulations at appropriate levels following a dynamic and static evaluation including cervical, thoracic, lumbar and pelvic (sacroiliac) spinal segments. Once all participants concluded their evaluation and interventions, a warm-up was performed again, and each participant was re-tested on the outcome measures listed previously. This study found no difference in time between the two groups; however, this study proved a sham group could be appropriately included which creates an opportunity to further investigate SMT in future studies.

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

This paper focused on observing the immediate effects of SMT on elite level athletes. Though no difference was found among the described outcome measures, it did prove as a viable study to further investigate randomized control trials on SMT as the sham-group was appropriate. A limitation of the study includes absence of subjective reporting of the participants which may be beneficial in a sport setting for participants who have back pain if improvement is noted. Another limitation was the outcome measures were re-tested 3 hours following interventions and players did not perform their tests in the same chronological order, indicating time may be a factor. In terms of how this study can be implemented into clinical practice, athletes (or really patients) who may have a preconceived notion that SMT would be beneficial to their function or performance would be appropriate to perform this manual therapy. I believe the true impact this study has it diving into further research of SMT whether is be different patient populations, the long-term of effects of SMT, or other relevant information that can impact how qualified providers implement this modality into their practice. Overall, this study was beneficial in proving a sham-group to be appropriate in future SMT studies, and possibly lead to further investigation of the SMT in athletes to enhance performance.

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