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Combination of reduced doses of naltrexone and cranial electrical stimulation in fibromyalgia: randomized clinical trial, blind, controlled with placebo

Association of low doses of Naltrexone and Transcranial Electrical Stimulation in Fibromyalgia: randomized clinical trial, blind, controlled with placebo

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7hk8n3
Enrollment
Unknown
Registered
2019-01-08
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fibromyalgia

Interventions

Drug
Device
Q65.020
E02.331.750
Low dose Naltrexone/Placebo for 21 consecutive days oral. Transcranial Direct Current Stimulation Sham/Active for 5 consecutive days. There are 4 intervention groups: 1- Active and Naltrexone (n=23) 2

Sponsors

Universidade La Salle
Lead Sponsor
Universidade La Salle
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Provide an informed consent to participate on the study; women with age between 18 and 65 years; medical diagnoses of fibromyalgia according to the American College of Rheumatology criterion (2010); know how to read and write; pain evaluated as bigger than six at the last 3 months on the Visual Analogic Scale; treatment of chronic use stable on the last 3 months;

Exclusion criteria

Exclusion criteria: Be using opioid drugs; pregnancy or non-use of contraceptive method; history of alcohol or drugs abuse on the last 6 months; historic of neurologic pathology; history of cardiac arrhythmia and use of drugs that change the vascular answer (adrenergic blockers, vasodilators); history of cranial traumatism moderated or severe; history of neurosurgery; systemic decompensated disease, and chronic inflammatory disease (Lupus, rheumatoid arthritis, Sjogren Syndrome, Reiter Syndrome); history of hypothyroidism non compensated; personal history of cancer, passed or in treatment.

Design outcomes

Primary

MeasureTime frame
Pain relief through association of low doses of naltrexone and transcranial direct current stimulation—

Secondary

MeasureTime frame
Measure the effect of low doses of naltrexone followed by tDCS on pain of fibromyalgic patients, evaluated by the verbal numeric scale of pain. Study if the effect of this association present some impact on the quality of life of these patients, evaluated by the fibromyalgia impact questionary. Study if this association induces changes on the nociceptive system, when evaluated by the sensorial quantitative test, and pain pressure threshold, such as the pain descending inhibitory system. Evaluate if the effect of this association induces changes in possible serum biomarkers of neuroplasticity (BDNF) and cytokines.—

Countries

Brazil

Contacts

Public ContactAndressa Souza

Universidade La Salle

andressasz@gmail.com+55-51-981975718

Outcome results

None listed

Source: REBEC (via WHO ICTRP)