Melatonin for chronic back pain (the MOCHA trial): study protocol for a randomized, double-blind, placebo-controlled trial
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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.
