Trial · NCT04502251
LDN and tDCS in Fibromyalgia
NCT04502251, Phase 2, Phase 3, Completed, Centro Universitario La Salle
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LDN and tDCS in Fibromyalgia. Trials, record NCT04502251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04502251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LDN and tDCS in Fibromyalgia
- NCT number
- NCT04502251
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 92 participants, actual
- Lead sponsor
- Centro Universitario La Salle
- Conditions
- Fibromyalgia
- Interventions
- Low-Dose Naltrexone, Transcranial Direct Current Stimulation, Placebo, Sham Transcranial Direct Current Stimulation
- First posted
- 2020-08-06
- Last updated
- 2020-08-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain in VAS | Change between baseline and after association (26 days from baseline) | Visual Analogue Scale (VAS) that goes from 0 cm (without pain) to 10cm (worst pain). |
| Secondary | Depressive symptoms | Change between baseline and after association (26 days from baseline) | Beck Depression Inventory (BDI-II) that goes from 0 (without depressive symptoms) to 63 (worst depressive symptoms) |
| Secondary | Anxiety levels | Change between baseline and after association (26 days from baseline) | State-Trait Anxiety Inventory (STAI) divided into state anxiety (from 0 to 52, the higher the worse) and trait anxiety (from 0 to 48, the higher the worse) |
| Secondary | Pain Catastrophizing Thought | Change between baseline and after association (26 days from baseline) | Pain Catastrophizing Scale (PCS): divided into rumination (from 0 to 16, the higher the worse), magnification (from 0 to 12, the higher the worse) and hopelessness (from 0 to 24, the higher the worse). Total goes from 0 to 52, the higher the worse |
| Secondary | Profile of Chronic Pain | Change between baseline and after association (26 days from baseline) | Profile of Chronic Pain Scale (PCP:S): divided into Frequency and Intensity of Pain (from 0 to 30, the higher the worse), Pain Effect in Activities (from 0 to 36, the higher the worse) and Pain Effect in Emotions (from 0 to 25, the higher the worse) |
| Secondary | Pain Pressure Threshold | Change between baseline and after association (26 days from baseline) | Pain Pressure Threshold (PPT) measured using an electronic algometer applied in the right forearm; and patients need to report the first pain sensation (minimum pain) and maximum pain. Threshold goes from 0 to the maximum value the patient can hold, the higher the value, better is the result |
| Secondary | Conditioned Pain Modulation | Change between baseline and after association (26 days from baseline) | Conditioned Pain Modulation (CPM) with an algometer (PPT task), the patient informed when felt a pain equal to 6 in the VAS. This pain level was applied in the right forearm for 30 seconds, while the left forearm (non-dominant hand) was submerged in water from 0˚C to 1.5˚C; after 30s, patients reported their pain in each of the arms. CPM = left forearm VAS - 6. (from -4 to 6, the value must be as closest to -4 as possible, meaning the higher the worse) |
| Secondary | Serum BDNF | Change between baseline and after association (26 days from baseline) | Blood sample collected and centrifuged, the supernatant aliquoted for BDNF analysis using ELISA technique, according to manufacturer's instructions (values start in 0, patients with fibromyalgia usually have higher levels of serum BDNF, therefore the higher the worse) |
Source ClinicalTrials.gov
Outcomes0
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.
Papers35
The papers the trial lists on ClinicalTrials.gov.
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/NCT04502251
GET https://conductscience.org/api/trials/v1/NCT04502251/papers?page=2