Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
92 participants
INTERVENTIONAL
2018-08-01
2020-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LDN + tDCS
Low Dose Naltrexone and Transcranial Direct Current Stimulation
Low-Dose Naltrexone
4.5mg daily dose, orally, during 26 days
Transcranial Direct Current Stimulation
An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.
LDN + Sham tDCS
Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation
Low-Dose Naltrexone
4.5mg daily dose, orally, during 26 days
Sham Transcranial Direct Current Stimulation
Sham-tDCS stimulation consists of an active current during 30 seconds
Placebo + tDCS
Placebo and Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation
An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.
Placebo
The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.
Placebo + Sham tDCS
Placebo and Sham Transcranial Direct Current Stimulation
Placebo
The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.
Sham Transcranial Direct Current Stimulation
Sham-tDCS stimulation consists of an active current during 30 seconds
Interventions
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Low-Dose Naltrexone
4.5mg daily dose, orally, during 26 days
Transcranial Direct Current Stimulation
An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.
Placebo
The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.
Sham Transcranial Direct Current Stimulation
Sham-tDCS stimulation consists of an active current during 30 seconds
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* women from 18 to 65 years
* confirmed diagnosis of fibromyalgia according 2016 American College of Rheumatology criteria
* read and write
* pain higher than 6 in the Visual Analogue Scale (VAS), in the last 3 months
* chronic stable treatment in the last 3 months.
Exclusion Criteria
* pregnancy or not using anticontraceptive
* history of alcohol or drug abuse in the last 6 months
* history of neurological pathologies
* history of arrhythmia
* history of use of drugs that might change vascular response
* history of head trauma
* history of neurosurgery
* decompensated systemic diseases or chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren syndrome, Reiter syndrome)
* history of non-compensated hypothyroidism
* personal history of cancer.
8 Years
65 Years
FEMALE
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Centro Universitario La Salle
OTHER
Responsible Party
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Andressa de Souza
Principal Investigator
Locations
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Universidade La Salle
Canoas, Rio Grande do Sul, Brazil
Countries
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References
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Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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70005317.5.0000.5307
Identifier Type: -
Identifier Source: org_study_id
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