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

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

doi: 10.1097/j.pain.0000000000000700
Research Paper

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.

The study suggests that honestly described open-label placebo pills may have a role in chronic low back pain relief.

aISPA—Instituto Universitário de Ciências Psicológicas, Sociais e da Vida, Department of Clinical and Health Psychology, Lisbon, Portugal

bNova Medical School—Faculdade de Ciências Médicas, da Universidade Nova de Lisboa, Lisbon, Portugal

cUnidade de Terapia de Dor do Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal

dProgram in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

Corresponding author. Address: ISPA—Instituto Universitário de Ciências Psicológicas, Sociais e da Vida, Rua Jardim do Tabaco, 34, 1140-041 Lisbon, Portugal. E-mail address: (C. Carvalho).

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Received June 01, 2016

Received in revised form July 21, 2016

Accepted August 16, 2016

© 2016 International Association for the Study of Pain