Open-label placebo treatment in chronic low back pain: a randomized controlled trial

Claudia Carvalho, Joaquim Machado Caetano, Lidia Cunha, Paula Rebouta, Ted J. Kaptchuk, Irving Kirsch

Research output: Contribution to journalArticle

140 Citations (Scopus)

Abstract

This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0-to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0-to 10-point Numeric Rating Scales and on the 0-to 10-point composite pain scale (P <0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P <0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (-1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

Original languageEnglish
Pages (from-to)2766-2772
Number of pages7
JournalPain
Volume157
Issue number12
DOIs
Publication statusPublished - Dec 2016

Keywords

  • NONCONSCIOUS ACTIVATION
  • PARACETAMOL
  • RESPONSES
  • EFFICACY
  • BURDEN
  • HEALTH

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