Chronic Low-back Pain (cLBP)Phase 3MELBACKNCT06859957
Melatonin for Patients With Chronic Low Back Pain
A Phase 3 study testing Melatonin 10 mg in people with Chronic Low-back Pain (cLBP), run by Bart Koes at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Melatonin 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Apr 2025to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Melatonin 10 mg, Placebo
- Keywords
- Chronic low back pain, Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 mgDrug
10 mg melatonin daily for a period of 6 weeks
PlaceboDrug
Daily placebo for a period of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Melatonin | Experimental | 10mg of melatonin daily for a period of 6 weeks Receives: Drug: Melatonin 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline to end of treatment at 6 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 3 months and 6 months follow-up
Adverse events
Using questionnaire according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start11 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bart Koes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bart Koes, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859957
- Sponsor's protocol ID
- PaNaMa 11825
- Other IDs
- 2024-514769-20-00
- Acronym
- MELBACK
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06859957
- Acronym / sponsor ID
- MELBACK / PaNaMa 11825
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- Chronic low back pain, Melatonin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Bart KoesUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Melatonin | Experimental | Drug: Melatonin 10 mg10mg of melatonin daily for a period of 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 10 mg10 mg melatonin daily for a period of 6 weeks | Drug | Melatonin |
| PlaceboDaily placebo for a period of 6 weeks | Drug | Placebo |
Primary outcome
Change in low back pain intensity
Time frame: 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
12 secondary outcomes
Back pain-related disability (RMDQ)
Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Global perceived effect score
Time frame: 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
Time frame: 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
Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Insomnia measured using the Insomnia Severity Index
Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Self-reported number of days with sick leave
Time frame: baseline to 3 months and 6 months follow-up
Emotional functioning using the Beck Depression Inventory (BDI)
Time frame: baseline to end of treatment at 6 weeks
Pain-related anxiety measured using the Pain Anxiety Symptoms Scale
Time frame: baseline to end of treatment at 6 weeks
Neuropathic pain measured using PainDETECT
Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Productivity losses measured using iMTA Productivity Cost Questionnaire
Time frame: baseline to 3 months and 6 months follow-up
Direct costs of medical care measured using iMCQ Medical Consumption Questionnaire
Time frame: baseline to 3 months and 6 months follow-up
Adverse events
Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin 10 mg in people with Chronic Low-back Pain (cLBP), run by Bart Koes at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in low back pain intensity (time frame: from baseline to end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.