Vagus Nerve Stimulation for Fibromyalgia Pain

This study is looking into whether transcutaneous Vagus Nerve Stimulation (tVNS) can help people with fibromyalgia (FM) manage their pain and other symptoms. Fibromyalgia is a condition that causes widespread pain and other issues, and current treatments don't always work well. Researchers believe that stimulating the vagus nerve, which plays a role in how our bodies sense and react to pain, might be a new way to help. You might be able to join if you are between 18 and 80 years old, have had a fibromyalgia diagnosis for at least three months, and your pain level is 4 or higher on a scale of 0 to 10. The main goal is to see if tVNS can reduce pain. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 60 participants. Participants will be randomly assigned to either the tVNS group or a control group.
What's involved
Participants will receive 30 minutes of stimulation twice a day for 4 weeks. Pain, fatigue, sleep, and quality of life will be measured at the beginning and end of the 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 weeks after the start of the study.

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NCT06009159

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Recruiting
NAAges 18–80InterventionalTreatment
Massachusetts General Hospital
~60 participants
Updated 2025-05-06 on ClinicalTrials.gov
What's tested:Transcutaneous Vagus Nerve Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A modified McGill Pain Questionnaire
Measured over at 0,4, weeks of the study,
Fibromyalgia
1 sites across 1 states
Massachusetts1

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  • A modified McGill Pain Questionnaireat 0,4, weeks of the study,

    Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain