title: Open-label placebo treatment in chronic low back pain: a randomized controlled trial.
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.
authors.affiliation: ISPA-Instituto Universitário de Ciências Psicológicas, Sociais e da Vida, Department of Clinical and Health Psychology, Lisbon, Portugal.
authors.forename: Cláudia
authors.initials: C
authors.lastname: Carvalho
authors.affiliation: Nova Medical School-Faculdade de Ciências Médicas, da Universidade Nova de Lisboa, Lisbon, Portugal.
authors.forename: Joaquim Machado
authors.initials: JM
authors.lastname: Caetano
authors.affiliation: Unidade de Terapia de Dor do Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.
authors.forename: Lidia
authors.initials: L
authors.lastname: Cunha
authors.affiliation: Unidade de Terapia de Dor do Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.
authors.forename: Paula
authors.initials: P
authors.lastname: Rebouta
authors.affiliation: Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Ted J
authors.initials: TJ
authors.lastname: Kaptchuk
authors.affiliation: Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Irving
authors.initials: I
authors.lastname: Kirsch
mesh_terms: D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D000704:Analysis of Variance; D059350:Chronic Pain / Q000628:therapy; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D026441:Mind-Body Therapies / Q000379:methods; D010147:Pain Measurement; D010919:Placebos / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D010919:Placebos