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

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