Trial · NCT06476392
Melatonin fOr CHronic bAck Pain (The MOCHA Trial)
NCT06476392, Phase 3, Completed, Odense University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin fOr CHronic bAck Pain (The MOCHA Trial). Trials, record NCT06476392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06476392
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin fOr CHronic bAck Pain (The MOCHA Trial)
- NCT number
- NCT06476392
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 220 participants, actual
- Lead sponsor
- Odense University Hospital
- Conditions
- Back Pain Lower Back Chronic, Insomnia
- Interventions
- Melatonin 10 MG, Placebo
- First posted
- 2024-06-26
- Last updated
- 2026-04-22
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in change in average pain intensity during the last 7 days between groups | Difference in change from baseline to 6 weeks | Average pain intensity during last 7 days will be assessed on a 0-10 Numeric Rating Scale (NRS) (ranging from 'no pain to 'worst imaginable pain') |
| Secondary | Insomnia severity | Baseline and after 6 weeks | Insomnia will be assessed with the Insomnia Severity Index (ISI), which is a brief 7 item patient-reported instrument with a score ranging from 0-28 (0=best;28=worst) |
| Secondary | Weekly pain intensity score trajectory | Weekly from baseline to 6 weeks | The trajectory of weekly numerical rating scale (NRS) pain intensity scores assessed on a 0-10 Numeric Rating Scale (NRS) (ranging from 'no pain to 'worst imaginable pain') from baseline to 6 weeks |
| Secondary | 30% pain intensity responders | Change from baseline to 6 weeks | Difference in number of patients with more than 30% improvement in pain intensity from baseline to 6 weeks |
| Secondary | 50% pain intensity responders | Change from baseline to 6 weeks | Difference in number of patients with more than 50% improvement in pain intensity from baseline to 6 weeks |
| Secondary | Global Perceived Effect (GPE) for pain | After 6 weeks | Assessment of overall change in pain from baseline to 6 weeks. Participants will be asked at 6 weeks: 'How is your pain now compared to when you entered this study', with 5 response options (much worse, worse, almost the same/unchanged, improved, much improved) |
| Secondary | Physical and Mental Health | Baseline and after 6 weeks | Physical and Mental Health will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health questionnaire version 1.2. Difference in change in physical and mental health scores between treatment groups from baseline to 6 weeks. PROMIS-10 consist of 10 questions concerning different aspects of global health. The first 9 questions are score on a Likert scale with 5 response options, and the last question asks about pain using a 0-10 numeric rating scale |
| Secondary | Back pain related disability | Baseline and after 6 weeks | Back pain related disability will be assessed using the Roland Morris Disability Questionnaire (RMQ). RMQ is a 23-item questionnaire (RMQ) developed to assess functional limitation and disability among patients with low back pain. The RMQ 23-item version will be used because 1) it has been cross-culturally validated in Danish (the original RMQ 24-item version has not), 2) the psychometric properties of the 23 vs 24 item RMQ have been shown to be similar. Each of the 23 items is yes/no (scored as 1 and 0 points respectively) with the scale ranging from 0 (no disability) to 23 (extremely severe disability). |
| Other | Time from sleep onset until final awakening (TST) from Ear EEG in subgroup of 60 patients | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Sleep efficiency (SE) from Ear EEG in subgroup of 60 patients | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). SE is the ratio of TST to time in bed / 100% |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41250112 | DERIVED |
Source PubMed
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/NCT06476392
GET https://conductscience.org/api/trials/v1/NCT06476392/registered?page=2