Melatonin for Patients with Chronic Low Back Pain

Phase 3

Not yet recruiting

• Conditions: Chronic Low-back Pain (cLBP)
• Interventions: Drug: Placebo; Drug: Melatonin 10 mg

• Registration Number: NCT06859957
• Lead Sponsor: Bart Koes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-31
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Study Start: 2025-03-19
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Melatonin	Melatonin 10 mg	10mg of melatonin daily for a period of 6 weeks

Primary Outcome Measures

Name	Time	Method
Change in low back pain intensity	from baseline to end of treatment at 6 weeks	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

Secondary Outcome Measures

Name	Time	Method
Back pain-related disability (RMDQ)	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up	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.
Global perceived effect score	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up	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.
Physical and mental health measured using the PROMIS Global Health	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 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.
Health related quality of life measured using the EQ-5D-5L	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up	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'.
Insomnia measured using the Insomnia Severity Index	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up	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)
Self-reported number of days with sick leave	baseline to 3 months and 6 months follow-up	Using a questionnaire
Emotional functioning using the Beck Depression Inventory (BDI)	baseline to end of treatment at 6 weeks	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)
Pain-related anxiety measured using the Pain Anxiety Symptoms Scale	baseline to end of treatment at 6 weeks	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.
Neuropathic pain measured using PainDETECT	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up	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.
Productivity losses measured using iMTA Productivity Cost Questionnaire	baseline to 3 months and 6 months follow-up	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.
Direct costs of medical care measured using iMCQ Medical Consumption Questionnaire	baseline to 3 months and 6 months follow-up	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.
Adverse events	baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up	Using questionnaire according to the Common Terminology Criteria for Adverse Events (CTCAE)

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands