Trial · NCT06859957
Melatonin for Patients With Chronic Low Back Pain
NCT06859957, Phase 3, Active not recruiting, Bart Koes
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin for Patients With Chronic Low Back Pain. Trials, record NCT06859957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06859957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin for Patients With Chronic Low Back Pain
- NCT number
- NCT06859957
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 222 participants, actual
- Lead sponsor
- Bart Koes
- Conditions
- Chronic Low-back Pain (cLBP)
- Interventions
- Melatonin 10 mg, Placebo
- First posted
- 2025-03-05
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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'. |
| Secondary | 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) |
| Secondary | Self-reported number of days with sick leave | baseline to 3 months and 6 months follow-up | Using a questionnaire |
| Secondary | 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) |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06859957
GET https://conductscience.org/api/trials/v1/NCT06859957/registered