Abstract
ImportanceIt is critically important to evaluate the effect of nonpharmacological treatments on low back pain and associated disability.ObjectiveTo 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 ParticipantsA 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.InterventionsThe 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 MeasuresCoprimary 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.ResultsOf 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 RelevanceChiropractic 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 RegistrationClinicalTrials.gov Identifier: NCT01692275
Highlights
Musculoskeletal disorders are the second leading cause of disability worldwide, led by low back pain (LBP), with an estimated LBP prevalence among US adults of 20%.1-3 The direct costs of back pain in the United States in 2010 were $34 billion,[4] with additional indirect costs including lost workplace productivity estimated at $200 billion.[5]
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, disability, and satisfaction as well as at each site
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
Summary
Musculoskeletal disorders are the second leading cause of disability worldwide, led by low back pain (LBP), with an estimated LBP prevalence among US adults of 20%.1-3 The direct costs of back pain in the United States in 2010 were $34 billion,[4] with additional indirect costs including lost workplace productivity estimated at $200 billion.[5]. The direct costs of back pain in the United States in 2010 were $34 billion,[4] with additional indirect costs including lost workplace productivity estimated at $200 billion.[5] In the US military, LBP is one of the most common reasons members seek medical care[6] and one of the most likely conditions to interrupt combat duty.[6,7] Common medical therapies for LBP, including nonsteroidal anti-inflammatory drugs, opioids, spinal fusions, and epidural steroid injections, demonstrate limited effectiveness[8,9,10]; many of these treatments have unacceptably high risk profiles.[8,11,12,13,14]. The primary therapeutic procedure used by doctors of chiropractic is spinal manipulative therapy.[18]
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