Lumbar Bracing for Chronic Low Back Pain: A Randomized Controlled Trial.

Purpose We performed this study to evaluate the effect of back bracing to treat patients with chronic low back pain (CLBP). Methods This was a prospective, unblinded, randomized controlled trial of 61 adults with uncomplicated CLBP (>12 weeks) and imaging findings of degenerative spondylosis, to assess the effectiveness of a semi-rigid back brace. All study participants received back school instruction. The treatment group also received a lumbar orthosis and were instructed to wear it as needed for symptom relief. At baseline, 6-weeks, 12-weeks, and 6-months post-intervention, we collected: Numerical Rating Scale (NRS) to measure pain intensity, Pain Disability Questionnaire (PDQ), Patient Reported Outcome Measurement Information System (PROMIS), and European Quality of Life (EQ-5D) to measure patient-reported function and quality of life. Results An interim analysis at the halfway point in enrollment (61 out of 120 planned participants) revealed the PDQ, PROMIS, and EQ-5D scores in the treatment group to be worse than in the control group, but no significant group differences in NRS scores. Outcome differences between groups analyzed over time revealed [Effect (p)]: PDQ: 0.84 (0.04); PROMIS: 0.78 (0.005); EQ5D: 0.06 (0.01); NRS: 0.02 (0.6). We halted the study because continuation was unlikely to produce significant changes to the results. Conclusion In patients with uncomplicated CLBP, a back brace when combined with education and exercise instruction did not provide any pain relief compared to education and exercise instruction alone.