OBJECTIVES: We aimed to evaluate the effectiveness of an 8-week meditation program (focused meditation) in patients with chronic low-back pain. DESIGN: A randomized clinical trial was conducted on 68 patients (55 years; 75% female) with chronic low-back pain who scored > 40 mm on a 100 mm visual-analogue-scale. Subjects were allocated to an 8-week meditation program (focused meditation) with weekly 75 min classes or to a self-care exercise program with a wait-list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed baseline and after 4 and 8 weeks. The primary outcome measure was the change in mean back pain at rest after 8 weeks. Secondary outcomes included function, pain-related bothersomeness, perceived stress, quality-of-life (QOL), and psychological outcomes. RESULTS: Twelve (meditation) and 4 (exercise) patients were lost to follow-up. The primary outcome, pain at rest after 8 weeks, was reduced from 59.3 +/- 13.9 mm to 40.8 +/- 21.8 mm with meditation versus 52.9 +/- 11.8 mm to 37.3 +/- 18.2 mm with exercise (adjusted group difference -1.4 (95% CI 11.6 to 8.8; p = NS) Perceived stress was significantly more reduced with meditation (p = 0.011). No significant treatment effects were found for other secondary outcomes as pain-related bothersomeness, function, quality-of-life and psychological scores, although the meditation group consistently showed non-significant better improvements compared to the exercise group. CONCLUSIONS: Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain. Future studies should include longer-term follow-ups and develop guided meditation programs to support compliance.

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