Status:
UNKNOWN
Neuromodulatory Effects of Transcranial Pulsed Current Stimulation in Fibromyalgia
Lead Sponsor:
Centro Universitario La Salle
Conditions:
Fibromyalgia
Eligibility:
FEMALE
30-65 years
Phase:
PHASE2
Brief Summary
Fibromyalgia (FM) is a functional syndrome characterized by musculoskeletal, diffuse and persistent (\> 3 months) chronic pain, that is also characterized by sleep disturbances, fatigue, humor changes...
Detailed Description
Recruitment: The study will be held in a clinical center at Novo Hamburgo (RS) -Brazil.Data collection will begin in December 2021, and it will end when sample size is achieved. A targeted approach wi...
Eligibility Criteria
Inclusion
- Women from 30 to 65 years old
- FM diagnosis according to ACR criteria (2016)
- Pain on VAS equal to or higher than 6 in the last 3 months
- Chronic stable treatment over the past 3 months.
Exclusion
- Pregnancy or lack of contraceptive use;
- History of alcohol or drug abuse in the last 6 months,
- Neurological disorders;
- Cardiac arrhythmia;
- Use of drugs that change vascular response;
- History of head trauma, mild or severe;
- History of neurosurgery;
- Decompensated systemic diseases;
- Current diagnosis or history of cancer
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05321693
Start Date
December 10 2021
End Date
December 10 2022
Last Update
April 11 2022
Active Locations (2)
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1
Universidade La Salle
Canoas, Rio Grande do Sul, Brazil, 92010-000
2
Instituto de Neuromodulação e Reabilitação Avançada
Novo Hamburgo, Rio Grande do Sul, Brazil, 93520575