Effect of Risk-Stratified Care on Disability Among Adults With Low Back Pain Treated in the Military Health System: A Randomized Clinical Trial

IMPORTANCE: Tailored treatments for low back pain (LBP) based on stratifying risk for poor prognosis have emerged as a promising approach to improve quality of care, but they have not been validated in trials at the level of individual randomization in US health systems. OBJECTIVE: To assess the clinical effectiveness of risk-stratified vs usual care on disability at 1 year among patients with LBP. DESIGN, SETTING, AND PARTICIPANTS: This parallel-group randomized clinical trial enrolled adults (ages 18-50 years) seeking care for LBP with any duration in primary care clinics within the Military Health System from April 2017 to February 2020. Data analysis was conducted from January to December 2022. INTERVENTIONS: Risk-stratified care, in which participants received physiotherapy treatment tailored for their risk category (low, medium, or high), or usual care, in which care was determined by participants’ general practitioners and may have included a referral to physiotherapy. MAIN OUTCOMES AND MEASURES: The primary outcome was the Roland Morris Disability Questionnaire (RMDQ) score at 1 year, with planned secondary outcomes of Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) and Physical Function (PF) scores. Raw downstream health care utilization was also reported within each group. RESULTS: Analysis included 270 participants (99 [34.1%] female participants; mean [SD] age, 34.1 [8.5] years). Only 21 patients (7.2%) were classified as high risk. Neither group was superior on the RMDQ (least squares [LS] mean ratio of risk-stratified vs usual care: 1.00; 95% CI, 0.80 to 1.26), the PROMIS PI (LS mean difference, −0.75 points; 95% CI −2.61 to 1.11 points), or the PROMIS PF (LS mean difference, 0.05 points; 95% CI, −1.66 to 1.76 points). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, using risk stratification to categorize and provide tailored treatment for patients with LBP did not result in better outcomes at 1 year compared with usual care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03127826