Evidence map›Paper›PMID 41250112›Full record

ArticleTrials2025

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

Kübra Kilic, Henrik Bjarke Vægter, Karin Due Bruun, Werner Vach, Jan Hartvigsen, Bart Willem Koes, Preben Kidmose, Jens Søndergaard, Jonas Bloch Thorlund

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06476392 (Melatonin fOr CHronic bAck Pain), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06476392 phase3completednot on this map

Melatonin fOr CHronic bAck Pain (The MOCHA Trial): A Randomized, Double Blind, Placebo-controlled Trial

TypeinterventionalSponsorOdense University HospitalRan2024 to 2026Enrolled220ConditionsBack Pain Lower Back Chronic, InsomniaArmsMelatonin 10 MG, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kübra KilicPain Research Group, Pain Center, Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark. Kubra.kilic@rsyd.dk.ORCID http://orcid.org/0009-0008-9445-8632
Henrik Bjarke VægterPain Research Group, Pain Center, Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.
Karin Due BruunPain Research Group, Pain Center, Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.
Werner VachBasel Academy for Quality and Research in Medicine, Basel, Switzerland.
Jan HartvigsenCenter for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
Bart Willem KoesResearch Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.
Preben KidmoseElectrical and Computer Engineering, Department of Engineering, Aarhus University, Aarhus, Denmark.
Jens SøndergaardResearch Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.
Jonas Bloch ThorlundCenter for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.

Funding

Region of Southern Denmark's Fund for Free and Strategic Research 2024-0027Sygesikringen "danmark", Sundhedsdonationer 2022-0020
6 · The paper itself

Abstract

backgroundChronic 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.

methodThe 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.

Indexed as

Back PainChronic PainMelatoninAdultDisability EvaluationDouble-Blind MethodEquivalence Trials as TopicFemaleHumansMaleMiddle AgedPain MeasurementRandomized Controlled Trials as TopicSleepSleep Initiation and Maintenance DisordersTime FactorsMelatoninChronic back painEar-EEGInsomniaMelatoninPainPain sensitivitySleep

Identifiers

PMID41250112
PMCPMC12625203

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.