taVNS Treatment for Fibromyalgia

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called transcutaneous electrical nerve stimulation (TENS) can help relieve pain for people with fibromyalgia, a condition that causes widespread pain and fatigue. The researchers at Massachusetts General Hospital want to enroll 60 participants who meet specific criteria for fibromyalgia. If you or someone you know has been diagnosed with fibromyalgia and is between the ages of 18 and 75, you may be eligible to participate in this study.

Participants in the trial will need to commit to receiving TENS treatment twice a day for four weeks. It's important to note that individuals with certain medical conditions, such as thyroid disease or arthritis, or those who have had serious heart or respiratory issues, will not be able to join. This study is not yet recruiting, but it represents an opportunity to potentially find a new way to manage fibromyalgia pain using safe electrical stimulation.

Gender

ALL

Eligibility criteria

• 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.