Status:
NOT_YET_RECRUITING
taVNS Treatment for Fibromyalgia
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with...
Eligibility Criteria
Inclusion
- Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
- Willingness to complete a 4-week, twice-a-day treatments.
- At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Exclusion
- Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome.
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
- Personal history of medical or psychiatric illness as determined by investigator.
- Pregnant or lactating.
- Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Key Trial Info
Start Date :
January 3 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04777500
Start Date
January 3 2026
End Date
March 1 2027
Last Update
June 3 2025
Active Locations (1)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129-2020