Researchers performed this randomized controlled trial to explore 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. They conclude that in chronic low back pain, OLP pills presented in a positive context might be helpful.

Methods

• Researchers evaluated pain severity 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.
• The other primary outcome was back-related dysfunction, evaluated on the Roland–Morris Disability Questionnaire.
• Participants on TAU received placebo pills for 3 additional weeks in an exploratory follow-up.
• They randomized 97 adults reporting persistent low back pain for more than 3 months’ duration and diagnosed by a board-certified pain specialist.

Results

• 83 adults completed the trial.
• 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 as compared to TAU.
• In the OLP group pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) and 0.2 (-0.3 to 0.8) in the TAU group.
• Also, OLP treatment reduced disability compared to TAU (P < 0.001), with a large effect size.
• In the OLP group improvement in disability scores was 2.9 (1.7-4.0) and 0.0 (-1.1 to 1.2) in the TAU group.
• The TAU group demonstrated significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5) after being switched to OLP.

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Abstract