Melatonin for Patients With Chronic Low Back Pain (MELBACK)

Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial

Low back pain is one of the conditions causing more disability worldwide. The use of pain medications is substantial in patients with chronic LBP. But the efficacy of commonly used analgesics is modest. More than half of patients with chronic LBP also has sleep problems. In recent years, some preliminary studies have shown a promising effect of melatonin for the treatment of pain.

The objective of this study is to investigate the efficacy of melatonin, relative to placebo, in patients with chronic LBP.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain (cLBP)
• Intervention / Treatment: Drug: Placebo; Drug: Melatonin 10 mg

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Prof. dr. B.W. (Bart) Koes; Phone Number: 010-7035882; Email: b.koes@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: Prof. dr. B.W. (Bart) Koes; Phone Number: 010-7035882; Email: b.koes@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 18-65
• understand and write Dutch
• LBP for 3 months or longer
• LBP must be present on 'most days' or 'every day' within the past 3 months
• LBP must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months
• average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days

Exclusion Criteria:

• LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis
• Radiating pain into the leg that goes further (down) than the knee
• Inflammatory/autoimmune arthritis
• Severe physical or psychiatric co-morbidities
• Contraindications to melatonin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Daily placebo for a period of 6 weeks
Experimental: Melatonin; 10mg of melatonin daily for a period of 6 weeks	Drug: Melatonin 10 mg; 10 mg melatonin daily for a period of 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in low back pain intensity	Change in low back pain intensity (average pain intensity past 7 days), measured on a 0-10 Numeric Rating Scale (NRS) where 0 means no pain and 10 means worst pain imaginable, from baseline to 6 weeks	from baseline to end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain-related disability (RMDQ)	Back pain-related disability is measured using the Roland Morris Disability Questionnaire (RMDQ). The RMDQ outcome ranges from 0-24, where a higher score means more disability.	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Global perceived effect score	Using Global perceived effect (GPE) questionnaire (7-point scale), where a score of 1 means highly satisfied/ great recovery and a score of 7 means highly dissatisfied / poor recovery.	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Physical and mental health measured using the PROMIS Global Health	Physical and mental health measured using the PROMIS Global Health questionnaire. A 10 items questionnaire, items are scored from 1-5 where a score of 5 is the best outcome and a score of 1 is the worst outcome.	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Health related quality of life measured using the EQ-5D-5L	Measured using the EQ-5D-5L (questionnaire). The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS (0-100) records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Insomnia measured using the Insomnia Severity Index	Measured using the Insomnia Severity Index (ISI) (questionnaire). The questionnaire consists of 7 questions, all scored with a score ranging from 0-3. The total score ranges from 0 (no sleeping problems) to 28 (severe sleeping problems)	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Self-reported number of days with sick leave	Using a questionnaire	baseline to 3 months and 6 months follow-up
Emotional functioning using the Beck Depression Inventory (BDI)	Measured using the Beck Depression Inventory (BDI) (questionnaire). A 21-item questionnaire, every item is scored from 0-3. This leads to a total score from 0 (best outcome) to 63 (worst outcome)	baseline to end of treatment at 6 weeks
Pain-related anxiety measured using the Pain Anxiety Symptoms Scale	Measured using the Pain Anxiety Symptoms Scale (PASS) (questionnaire). A 40-item questionnaire (ranging from 0-200), where a high score means high pain related anxiety.	baseline to end of treatment at 6 weeks
Neuropathic pain measured using PainDETECT	Measured using PainDETECT (questionnaire). A 9-item questionnaire, with 7 weighted descriptor items (from never to very strongly) and 2 items related to spatial and temporal pain characteristics. A total score of 19 or more is indicative of likely neuropathic pain.	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Productivity losses measured using iMTA Productivity Cost Questionnaire	iMTA Productivity Cost Questionnaire is used. The questionnaire consists of 18 questions in total. To calculate the costs of production losses, volumes are multiplied by unit costs.	baseline to 3 months and 6 months follow-up
Direct costs of medical care measured using iMCQ Medical Consumption Questionnaire	Direct costs of medical care measured using iMCQ Medical Consumption Questionnaire. The questionnaire consists of 29 items. Questions are answered with yes/no, or participants are asked to fill in a number, for example "How many appointments with the physiotherapist did you have in the past 3 months?". The costs of medical consumption are calculated by multiplying measured volumes of care by the cost price per unit of care.	baseline to 3 months and 6 months follow-up
Adverse events	Using questionnaire according to the Common Terminology Criteria for Adverse Events (CTCAE)	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity patterns measured using a GENEActiv activity tracker	A GENEActiv activity tracker is worn for a period of 7 days during the 6-week treatment period by a subgroup of 60 participants. This device can measure activity and sleep. This measure is use as an explorative objective and only descriptive statistics of the data will be given. GENEActiv software is used to analyse the data.	7 days during treatment period
Sleep reports measured using a GENEActiv activity tracker	A GENEActiv activity tracker is worn for a period of 7 days during the 6-week treatment period by a subgroup of 60 participants. This device can measure activity and sleep. A sleep report is created using the GENEActiv software. This measure is used as an explorative measure, only descriptive statistics are done.	7 days during treatment period

Collaborators and Investigators

• Sponsor: Bart Koes

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Melatonin; Chronic low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antioxidants; Protective Agents; Melatonin
• Other Study ID Numbers: PaNaMa 11825; 2024-514769-20-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No