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Melatonin for Chronic back pain
EU CTIS ID: 2023-503530-41-00
What this study is testing
The aim of this randomized double-blind placebo controlled clinical superiority trial is to investigate if daily treatment with Melatonin 10 mg once daily before bedtime for 6 weeks is superior compared with placebo in improving pain intensity assessed at 6 weeks after treatment initiation in patients with chronic back pain.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 to 64 years
- 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 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).
You likely can't join if
- Known abuse of alcohol or other substances
- Inflammatory/autoimmune arthritis (reported by participant)
- Patients with contraindications to Melatonin according to the Danish Medicines Agencys approved product information: 1) Moderate to severe kidney insufficiency (GFR < 30 mL/min), 2) Moderate to severe liver insufficiency (ALAT must not be elevated more than 3-fold over highest reference level) 3) Auto-immune diseases 4) Epilepsy 5) Warfarin use 6) Benzodiazipin use (including hypnotics) 7) Fluvoxamin use (Ciprofloxacin, Norfloxacin) 8) Calcium antagonist use (Verapamil, Nifedepin) 9) Pregnancy or pregnancy-wish or breastfeeding (a negative pregnancy test has to be available for all fertile female patients at baseline) 10) 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
- Self-selected non-user of e-boks
- Opioid use (reported by participant)
See the full eligibility criteria
Who can join
- Age 18 to 64 years
- 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 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).
What rules you out
- Known abuse of alcohol or other substances
- Inflammatory/autoimmune arthritis (reported by participant)
- Patients with contraindications to Melatonin according to the Danish Medicines Agencys approved product information: 1) Moderate to severe kidney insufficiency (GFR < 30 mL/min), 2) Moderate to severe liver insufficiency (ALAT must not be elevated more than 3-fold over highest reference level) 3) Auto-immune diseases 4) Epilepsy 5) Warfarin use 6) Benzodiazipin use (including hypnotics) 7) Fluvoxamin use (Ciprofloxacin, Norfloxacin) 8) Calcium antagonist use (Verapamil, Nifedepin) 9) Pregnancy or pregnancy-wish or breastfeeding (a negative pregnancy test has to be available for all fertile female patients at baseline) 10) 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
- 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)
- Suicide and self-damage thoughts (reported by participant)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.