Effects of Spinal Manipulative and Mobilization Therapies in Young Adults with Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial – Duke Center of Excellence in Manual and Manipulative Therapy

Author Names

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

Reviewer Name

Julianna Hom, SPT

Reviewer Affiliation(s)

Duke University DPT

Paper Abstract

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

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

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

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

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

Were study participants and providers blinded to treatment group assignment?

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

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

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

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

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

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

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

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

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

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

Key Finding #1

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

Key Finding #2

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

Key Finding #3

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

Please provide your summary of the paper

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

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

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