Melatonin for chronic back pain relief
Melatonin for CHronic BAck Pain (The MOCHA Trial): a Randomized, Double Blind, Placebo-controlled Trial
This study is testing if taking melatonin every night can help people with chronic lower back pain feel less pain and improve their overall well-being.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense, Funen) |
| Trial ID | NCT06476392 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of daily melatonin treatment in reducing pain intensity in patients suffering from chronic lower back pain. Participants will receive either 10 mg of melatonin or a placebo before bedtime for six weeks. The primary outcome will measure changes in pain intensity on a numeric rating scale, while secondary outcomes will assess pain-related disability, insomnia severity, and overall health-related quality of life. The study aims to provide a safer alternative to traditional pain medications, which often have significant side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 64 with chronic lower back pain lasting at least three months and an average pain intensity of 4 or higher.
Not a fit: Patients with acute back pain or those who do not meet the pain intensity criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer, non-addictive option for managing chronic back pain and improving sleep quality.
How similar studies have performed: While melatonin has been studied for various conditions, this specific application for chronic back pain is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: To be eligible for the trial patients must fulfill all the following inclusion criteria: * Age 18 to 64 years * Understand and write Danish * Back pain for 3 months or longer * Back pain must be present on 'most days' or 'every day' within the past 3 months (will be checked by the question: 'In the past 3 months, how often did you have back pain? - response options: 'never'; 'some days'; 'most days'; 'every day') * Back pain must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months. (will be checked by the question: 'In the past 3 months, how often did your back pain limit your life or work activities? - response options: 'never'; 'some days'; 'most days'; 'every day') * Average pain intensity of 4 or higher on 0-10 Numeric Rating Scale \[NRS\] in the past 7 days (ranging from 'no pain' to 'worst imaginable pain'). * All fertile women must use safe contraception (Spiral, birth control pills, contraceptive patch, contraceptive vaginal ring or gestagen injections) for 3 weeks before and 1 week after the trial. If the participants' normal lifestyle includes sexual abstinence, they do not have to use contraception. Instead, they can give an oral informed consent, that they will be sexually abstinent during the trial. A woman is considered non-fertile if she is sterilized, hysterectomized, bilateral oophorectomized or is postmenopausal. A woman is considered postmenopausal when vaginal bleeding has been absent for 1 year (reported by the participant). Exclusion Criteria: Patients will be excluded based on any of the following exclusion criteria: * Known abuse of alcohol or other substances * Self-selected non-user of e-boks * Opioid use (reported by participant) * Known malignancies within past 6 months (reported by participant) * Known fractures within past 4 months (reported by participant) * Known lumbar radiculopathy (reported by participant) * Known spinal stenosis (reported by participant) * Severe psychiatric disorders and/or psychotic symptoms evaluated by the investigator (reported by participant) * Suicide and self-damage thoughts (reported by participant) * Inflammatory/autoimmune arthritis (reported by participant) Patients with contraindications to Melatonin according to the Danish Medicines Agencys approved product information: * Moderate to severe kidney insufficiency (GFR \< 30 mL/min) * Moderate to severe liver insufficiency (ALAT must not be elevated more than 3-fold over highest reference level) * Auto-immune diseases * Epilepsy * Warfarin use * Benzodiazipin use (including hypnotics) * Fluvoxamin use (Ciprofloxacin, Norfloxacin) * Calcium antagonist use (Verapamil, Nifedepin) * Pregnancy or pregnancy-wish or breastfeeding (a negative pregnancy test has to be available for all fertile female patients at baseline) * Intolerance to melatonin For the EEG subgroup: If the anatomy of the outer ear making it impossible to do ear EEG monitoring If there have a perforation of the tympanic membrane (eardrum) If they have an ear tube in the tympanic membrane If their ear piercings that are not compatible with ear EEG. If they use anticoagulants
Where this trial is running
Odense, Funen
- Pain Center, University Hospital Odense — Odense, Funen, Denmark (Recruiting)
Study contacts
- Principal investigator: Karin Due Bruun, PhD — University Hospital Odense
- Study coordinator: Kubra Kilic, MSc
- Email: Kubra.Kilic@rsyd.dk
- Phone: 004565413869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.