Effects of taVNS on Fibromyalgia Pain

This study is looking into how transauricular vagus nerve stimulation (taVNS) might help people with fibromyalgia (FM) manage their pain. taVNS is a simple, non-invasive device that uses small electrodes placed on your ear. Researchers believe it could affect how you feel pain. To join, you must be over 18, have a diagnosis of fibromyalgia for at least six months with a pain level of 3 or higher on a 0-10 scale, and be able to feel sensation on your forearm. The main goal is to see if taVNS can reduce pain severity, measured over four weeks. The study plans to enroll 152 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 152 participants to test transauricular vagus nerve stimulation (taVNS). The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain severity will be measured from the start of the study up to 4 weeks.

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NCT06193317

Effects of taVNS on Fibromyalgia Pain

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Spaulding Rehabilitation Hospital
~152 participants
Updated 2025-09-19 on ClinicalTrials.gov
What's tested:Transauricular vagus nerve stimulation (taVNS)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
pain severity using the Brief Pain Inventory (BPI pain)
Measured over From Baseline to Visit 19 (at 4 weeks)
Fibromyalgia, Pain
1 sites across 1 states
Massachusetts1

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  • pain severity using the Brief Pain Inventory (BPI pain)From Baseline to Visit 19 (at 4 weeks)

    Brief Pain Inventory (BPI) is a short self-assessment questionnaire that provides information on various dimensions of pain including how pain developed, the types of pain a patient experiences, time of day pain is experienced, as well as current ways of alleviating pain. The BPI also includes the Visual Analog Scale (VAS) Pain scale, a simple 10-point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' pain, on average and at the present time. The BPI provides information on pain intensity (the sensory dimension) and the degree to which pain interferes with function (the reactive dimension).