Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Thomas reported receiving grants from the National Institutes of Health (NIH) during the conduct of this study. Dr Clark reported receiving grants from the NIH during the conduct of the study and grants from the Osteopathic Heritage Foundations and the American Osteopathic Association outside the submitted work. Dr Russ reported receiving grants from the NIH during the conduct of the study. Dr France reported receiving grants from the NIH during the conduct of the study. Dr Ploutz-Snyder reported receiving grants from the NIH, the Department of Justice, NASA, the Merk Foundation, and the Ethel and James Flinn Foundation for effort as a biostatistician during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram

Figure 2.. Change in Self-reported Pain and Disability Scores

A, Self-reported assessment of average pain during the last 7 days (Numerical Pain Rating Scale score; range, 0-10, with higher scores indicating greater pain). B, Self-reported disability (Roland-Morris Disability Questionnaire; range, 0-24, with higher scores indicating greater disability). Means and 95% CIs (error bars) are plotted for ratings collected at the initial visit, 72 hours after completing 3 weeks of treatment (ie, primary end point), and 4 weeks after treatment completion (ie, follow-up). The plots are offset along the time axis for visual clarity.