Abstract
BACKGROUND: Chronic back pain remains a leading cause of disability worldwide, with high societal and healthcare costs and limited effective treatment options. More than 50% of people with chronic back pain also report insomnia symptoms. Melatonin, primarily known for its use in treating insomnia and jetlag, has shown promising effects as a pain medication in chronic non-musculoskeletal pain conditions. We aim to determine the efficacy of 6 weeks of melatonin compared with placebo in reducing average pain intensity in patients with chronic disabling back pain. METHOD: The Melatonin for Chronic Back Pain (MOCHA) trial is a 1:1 randomized, placebo-controlled, double-blind, superiority trial including 220 patients with chronic disabling back pain randomized to either 10 mg (given as two 5 mg tablets) melatonin daily for 6 weeks or an identically looking placebo tablet. The primary outcome is the between-group difference in change in average pain intensity during the last 7 days from baseline to 6 weeks. Secondary outcomes include insomnia severity, back pain-related disability, global perceived effect, physical and mental health, and pain sensitivity. Exploratory outcomes are physiological sleep metrics assessed with ear electroencephalography (EEG). DISCUSSION: This trial evaluates the efficacy of melatonin, an inexpensive and widely available intervention that could potentially reduce pain and sleep problems in a population with few effective treatment options available. Trial registration CTIS EU-CT 2023-503530-41-00. Registered on March 4th, 2024. CLINICALTRIALS: gov NCT06476392. Registered on June 20th, 2024.