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Not yet recruiting Not applicable NCT04777500

taVNS Treatment for Fibromyalgia

No applicable phase (e.g. observational)
Conditions: Fibromyalgia

Sponsor: Massachusetts General Hospital

trial.available_in: БГ
Overview
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 Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.
Who can participate
Inclusion Criteria: * 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 Criteria: * 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.
Interventions
Auricular transcutaneous electrical nerve stimulation device
DEVICE
Locations 1
United States (1)
Massachusetts General Hospital
Charlestown , Massachusetts
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
03.10.2026
Completion date
01.03.2027
Registry ID
NCT04777500
Source
clinicaltrials.gov
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