Patients with acute or subacute low back pain at increased risk of progression to chronic impactful low back pain may have lower pain impact scores at 1 year with clinician-supported biopsychosocial self-management compared with guideline-based medical care. Spinal manipulation therapy may not improve outcomes compared with medical care nor provide additional benefit when combined with self-management.
In the PACBACK trial, researchers enrolled 1,000 adult participants with a nonspecific low back pain episode lasting 2 to 12 weeks who had a moderate or high risk of progression to chronicity according to the STarT Back Screening Tool. They randomly assigned the patients to undergo either clinician-supported biopsychosocial self-management, spinal manipulation therapy, both interventions, or guideline-based medical care. The primary outcome was low back pain impact during months 10 through 12, measured using the National Institutes of Health Task Force on Chronic Low Back Pain scale.
The mean low back pain impact scores at 10 to 12 months were lower among the participants receiving clinician-supported biopsychosocial self-management compared with those in the participants receiving guideline-based medical care (15.3 vs 17.0). The patients in the self-management group were also more likely to achieve at least a 50% reduction in low back pain impact, with 64% meeting that threshold compared with 55% of the patients receiving medical care. The researchers reported statistically significant differences across the treatment groups for the primary outcome. Spinal manipulation therapy produced results similar to those of medical care and did not produce improved outcomes when added to self-management.
Several secondary outcomes also favored self-management. At 12 months, 34% of the participants receiving self-management met the study definition of chronic low back pain compared with 54% of those receiving medical care. Chronic low back pain that interfered with daily activities at 12 months was reported by just 15% of patients receiving self-management compared with 27% of those receiving medical care. Those receiving self-management also reported lower health care utilization and drug use, fewer days with low back pain, reduced disability, greater pain self-efficacy, and better global improvement ratings compared with the patients receiving medical care.
More than 50% of the patients in all treatment groups achieved at least a 50% reduction in their low back pain impact scores by the end of follow-up period. Prespecified subgroup analyses found no statistically significant interaction between treatment effects and either baseline risk category or symptom duration. The researchers stated that the benefits associated with self-management were observed in both medium- and high-risk groups.
Mediation analyses suggested that improvements in pain self-efficacy, kinesiophobia, and pain catastrophizing accounted for much of the benefit associated with self-management. Together, these psychosocial factors explained 76% of the treatment effect on low back pain impact scores at 1 year.
In an accompanying invited commentary, Steven J. Atlas, MD, MPH, of the Division of General Internal Medicine at Mass General Brigham and Harvard Medical School, wrote that the trial's findings should be interpreted in light of the modest effect sizes and the specialized research setting in which the interventions were delivered. He noted that the results may not fully translate to routine clinical practice but said the findings support a role for clinician-supported biopsychosocial self-management among patients at increased risk of chronic disabling low back pain.
The researchers noted several limitations. Patients and clinicians were not blinded to treatment assignment, and the study did not control for differences in treatment time, attention, expectations, or practitioner effects. In addition, the study population was predominantly White, highly educated, and relatively affluent, which may limit generalizability to broader patient populations.
In their conclusion, lead study author Gert Bronfort, PhD, DC, of the Integrative Health and Wellbeing Research Program at the Earl E. Bakken Center for Spirituality & Healing at the University of Minnesota, and colleagues wrote that “the consistent results from the responder analyses and most secondary outcomes suggest the differences between clinician-supported self-management and medical care are clinically relevant.”
Full disclosures are available in the published article.
Source: JAMA Internal Medicine, Editorial