IMPORTANCE: Low back pain (LBP) is influenced by interrelated physical, psychological, and social factors. However, most treatments focus on symptom reduction without addressing the underlying biopsychosocial needs of patients.
OBJECTIVE: To determine the effectiveness of spinal manipulation and clinician-supported biopsychosocial self-management vs medical care for adults with increased risk of chronic disabling LBP.
DESIGN, SETTING, AND PARTICIPANTS: This 2 × 2 factorial randomized clinical trial enrolled participants in 3 research clinics at the Universities of Minnesota and Pittsburgh from November 2018 to May 2023; final follow-up was in June 2024. Adults with acute or subacute LBP at moderate to high risk of chronicity based on the STarT Back tool were randomized to 1 of 4 groups, with interventions lasting up to 8 weeks. Statistical analysis was conducted from November 2024 to June 2025.
INTERVENTIONS: Spinal manipulation therapy (n = 201), supported self-management (n = 305), or combined supported self-management with spinal manipulation (n = 193) compared with guideline-based medical care (n = 301). Physical therapists and chiropractors provided spinal manipulation and supported self-management.
MAIN OUTCOMES AND MEASURES: The 2 primary outcomes averaged over a follow-up of 1 year were monthly low back disability (Roland-Morris Disability Questionnaire) and weekly pain intensity (numerical rating scale). Secondary analysis examined the proportion of participants achieving a 50% or higher reduction in the primary outcome measures.
RESULTS: Among the 1000 participants randomized (mean [SD] age, 47 [16] years; 58% female), 93% completed the trial. The omnibus test for differences across the 4 treatment groups was statistically significant for disability (P = .001; supported self-management, 4.7; spinal manipulation, 5.5; combined supported self-management with spinal manipulation, 4.8; medical care, 5.9) but not pain intensity (P = .16; supported self-management, 2.8; spinal manipulation, 3.0; combined supported self-management with spinal manipulation, 2.8; medical care, 3.0). Averaged over 12 months, LBP disability was significantly lower compared with medical care for supported self-management (mean difference, -1.2 [95% CI, -1.9 to -0.5]) and supported self-management with spinal manipulation (mean difference, -1.1 [95% CI, -1.9 to -0.3]) but not spinal manipulation alone (mean difference, -0.4 [95% CI, -1.2 to 0.4]). Group differences in pain intensity were not statistically significant; point estimates ranged from -0.2 to 0. Both supported self-management groups had higher proportions of patients achieving a 50% or greater reduction in disability (supported self-management, 67%; spinal manipulation, 54%; combined supported self-management with spinal manipulation, 65%; medical care, 54%).
CONCLUSIONS AND RELEVANCE: For patients with acute or subacute LBP at increased risk of chronic disabling LBP, clinician-supported biopsychosocial self-management showed statistically significant but small reductions in disability, but not pain, vs medical care over 1-year follow-up, and spinal manipulation alone showed no significant difference for either outcome.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03581123.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
Although most primary care clinicians likely know that time is the best treatment for acute low back pain, it is helpful to have this updated trial showing that this remains true.
Physician rater
The term "spinal manipulation" literally involves hundreds of spinal methodologies. Knowing this disputes the whole premise.
Physician rater
Interesting information.
, McMaster University