IMPORTANCE: Acute and subacute low back pain (LBP) often progresses to a chronic impactful back problem in patients with elevated risk. The most effective way to prevent this progression is unknown.
OBJECTIVE: To determine the effectiveness of spinal manipulation and clinician-supported biopsychosocial self-management vs medical care for preventing chronic impactful LBP.
DESIGN, SETTING, AND PARTICIPANTS: This 2 × 2 factorial randomized clinical trial was conducted in research clinics at the University of Minnesota and the University of Pittsburgh, Pennsylvania, from November 2018 to May 2023, with follow-up concluding in June 2024. Adults with acute or subacute LBP with a moderate to high risk of chronicity were included.
INTERVENTIONS: Four interventions were applied for 8 weeks: spinal manipulation therapy; supported self-management; combined spinal manipulation therapy and supported self-management; and guideline-based medical care. Spinal manipulation and supported self-management were provided by physical therapists and chiropractors.
MAIN OUTCOMES AND MEASURES: Mean LBP impact score per the US National Institutes of Health Task Force on Chronic LBP scale (8 [best] to 50 [worst]) during 10 to 12 months, responder analyses of group differences in the proportion of participants with at least 50% reductions. A reduction of 30% was considered the minimal clinically important within-patient difference. Secondary outcomes included measures of chronicity and LBP burden (ie, health care and medication use, productivity), important patient-reported outcomes (eg, improvement, satisfaction), biopsychosocial measures (eg, Patient-Reported Outcomes Measurement Information System), and potential mediating psychosocial measures (eg, self-efficacy, kinesiophobia, pain catastrophizing).
RESULTS: Of the 1000 participants (mean [SD] age, 47 [16] years; 577 females [58%]) randomized, 928 (93%) completed the trial. An omnibus test of the primary outcome was statistically significant (P = .006). Group differences in mean LBP impact scores were small but statistically significant: supported self-management vs medical care, -1.7 (95% CI, -2.7 to -0.6); combined self-management and spinal manipulation vs medical care, -1.3 (95% CI, -2.5 to 0). Spinal manipulation therapy and medical care did not differ: -0.3 (95% CI, -1.5 to 1.0). Adding spinal manipulation to supported self-management did not provide additional benefit. The supported self-management group had a significantly higher proportion with at least 50% reduction in LBP impact vs medical care (64% vs 55%). Supported self-management also performed better on most secondary outcomes compared to medical care, including 12% fewer reporting chronic pain that frequently interfered with regular activities. Mediation analyses showed changes in psychosocial factors at 6 months and explained 76% of supported self-management effects at 1 year.
CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that for patients with acute or subacute LBP at increased risk of chronic impactful LBP, clinician-supported biopsychosocial self-management resulted in a lower mean LBP impact score at 10 to 12 months vs medical care; spinal manipulation and medical care did not differ. While the LBP impact difference was small, the consistent results of the responder analyses and most secondary outcomes suggest differences between clinician-supported self-management and medical care are clinically relevant.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03581123.
| Discipline Area | Score |
|---|---|
| Physician |  |
| Rehab Clinician (OT/PT) | |
Physician rater
This is a very useful trial for a very common question, and it advances our knowledge in a meaningful way, even if it doesn't change practice. The supported self-management and the other interventions are worth delving into, as is the companion article looking at longer-term pain outcomes.
Rehab Clinician (OT/PT) rater
Young physiotherapists heavily emphasize manual therapy in this patient population, while downplaying the importance of exercise and the biopsychosocial concept. This study provides powerful evidence supporting previous literature, proving that a biopsychosocial approach yields clinically relevant long-term benefits, while manual therapy falls short of providing additional value.
Rehab Clinician (OT/PT) rater
As a geriatric physical therapist, this article confirms the importance of complementary services and biopsychosocial components for a holistic approach in LBP.
, McMaster University