Mindfulness-based stress reduction for failed back surgery syndrome: a randomized controlled trial.

CONTEXT Previous studies on the effect of mindfulness-based stress reduction (MBSR) therapy on chronic pain syndromes have been hampered by study design. OBJECTIVE To evaluate short-term efficacy of MBSR therapy for improving quality of life in adults with failed back surgery syndrome (FBSS). DESIGN A single-center, prospective, randomized, single-blind, parallel-group clinical trial. PATIENTS AND SETTING Participants were recruited from a multidisciplinary spine and rehabilitation center in the greater Portland, Maine, area. INTERVENTIONS AND MAIN OUTCOME MEASURES Patients were randomly assigned at baseline to receive either MBSR therapy plus traditional therapy or traditional therapy alone for an 8-week period. Those receiving MBSR therapy completed weekly group sessions, and the control group continued with their traditional care as prescribed by their medical care providers. At study enrollment and at 12-week follow-up, all participants completed questionnaires on pain, quality of life, functionality, analgesic use, and sleep quality. Patients in the intervention group also completed questionnaires at 40-week follow-up. RESULTS The final analysis included 25 patients with FBSS; 15 patients were in the MBSR intervention arm, and 10 in the control group. At 12-week follow-up, patients in the intervention arm had a mean 7.0-point increase (on an 108-point [corrected] scale) in pain acceptance and quality of life on the Chronic Pain Assessment Questionnaire, a mean 3.6-point [corrected] decrease (on a 24-point scale) in functional limitation on the Roland-Morris Disability Questionnaire, a mean 6.9-point [corrected] reduction (on a 30-point scale) in pain level on the Summary Visual Analog Scale for Pain, a mean 1.5-point [corrected] reduction (on a 4-point scale) in frequency of use and potency of analgesics used for pain and recorded on logs, and a mean 2.0-point [corrected] increase (on a 5-point scale) in sleep quality on the abridged Pittsburgh Sleep Quality Inventory. These results were statistically and clinically significant compared to outcomes for the control group. CONCLUSION The results suggest that MBSR can be a useful clinical intervention for patients with FBSS.