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Clinical Trial
. 2018 May 18;1(1):e180105.
doi: 10.1001/jamanetworkopen.2018.0105.

Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial

Christine M Goertz  1 , Cynthia R Long  1 , Robert D Vining  1 , Katherine A Pohlman  2 , Joan Walter  3 , Ian Coulter  4
Affiliations
Clinical Trial

Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial

Christine M Goertz et al. JAMA Netw Open. .

Abstract

Importance: It is critically important to evaluate the effect of nonpharmacological treatments on low back pain and associated disability.

Objective: To determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone.

Design, setting, and participants: A 3-site pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at 2 large military medical centers in major metropolitan areas and 1 smaller hospital at a military training site. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source.

Interventions: The intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.

Main outcomes and measures: Coprimary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use. The coprimary outcomes were modeled with linear mixed-effects regression over baseline and weeks 2, 4, 6, and 12.

Results: Of the 806 screened patients who were recruited through either clinician referrals or self-referrals, 750 were enrolled (250 at each site). The mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favor of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, -1.1; 95% CI, -1.4 to -0.7), disability (mean difference, -2.2; 95% CI, -3.1 to -1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favor of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious related adverse events were reported.

Conclusions and relevance: Chiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care.

Trial registration: ClinicalTrials.gov Identifier: NCT01692275.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Goertz reported receiving personal fees from Spine IQ as chief executive officer and from the American Chiropractic Association as a consultant outside the submitted work; and owning stock in Prezacor, Inc. Dr Pohlman reported receiving an educational fellowship from NCMIC Foundation outside the submitted work. Ms Walter reported receiving grants from RAND Corporation during the conduct of the study; and receiving grants from the US Army Medical Research Acquisition Agency, Samueli Institute, and RAND Corporation outside the submitted work. Dr Coulter reported receiving grants from RAND Corporation during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Trial Flow Diagram
UMC indicates usual medical care.
Figure 2.
Figure 2.. Adjusted Mean Low Back Pain (LBP) Intensity and Disability Over Time by Site
Estimated from mixed-effects models using all observed data, an unstructured covariance, and terms in the model for time (as a categorical variable), site, and site × group, time × group, and site × time × group interactions, adjusted for sex, age, pain duration, and worst pain during the past 24 hours. Low back pain intensity during the prior week was assessed by the Numerical Rating Scale (scores ranging from 0 [no LBP] to 10 [worst possible LBP]); LBP-related functional disability was assessed by the Roland Morris Disability Questionnaire (scores ranging from 0-24, with higher scores indicating greater disability). Walter Reed indicates Walter Reed National Military Medical Center, Bethesda, Maryland; Pensacola indicates Naval Hospital Pensacola, Pensacola, Florida; and San Diego indicates Naval Medical Center San Diego, San Diego, California.
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