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Effects of open-label placebo on pain, functional disability and spine mobility in chronic back pain patients: a randomized controlled trial.

Chronic back pain is a major global health problem, while its treatment is hampered by a lack of efficacy and restricted safety profile of common front-line therapies. The present trial aims to determine whether a 3-week open-label placebo treatment reduces pain intensity, and subjective and objective functional disability in chronic back pain patients. This randomized controlled trial, following a pretest-posttest design, enrolled 127 chronic back pain patients (pain duration > 12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany. Patients randomized to the open-label placebo group received a 3-week open-label placebo treatment. Patients in the treatment as usual group received no intervention. Both groups continued treatment as usual. Primary outcome was the change in pain intensity. Secondary outcomes included patient-reported functional disability, objective measures of spine mobility and depression, anxiety and stress. 122 chronic back pain patients were randomized to the open-label placebo group (N=63) or treatment as usual group (N=59). Open-label placebo application led to a larger reduction of pain intensity (-0.62±0.23 vs. 0.11±0.17, all M ± SE, p=.001, d=-0.44) as well as patient-reported functional disability (3.21±1.59 vs. 0.65±1.15, p=.020, d=-0.45) and depression scores (-1.07±0.55 vs. 0.37±0.39, p=.010, d=-0.50) compared to treatment as usual only. OLP treatment did not affect objective mobility parameters, anxiety and stress. Our study demonstrates that a 3-week open-label placebo treatment is safe, well tolerated and reduces pain, disability and depressive symptoms in chronic back pain. Trial registration: German Clinical Trials Register, DRKS00012712.