Vagus nerve stimulation for fibromyalgia pain relief
Investigation of the Effects of Transcutaneous Vagus Nerve Stimulation on Fibromyalgia. A Double Blind, Sham-controlled Randomized Clinical Trial
This study is testing whether a device that stimulates the vagus nerve can help people with fibromyalgia feel less pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | Female |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens, Greece) |
| Trial ID | NCT06912334 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of transcutaneous vagus nerve stimulation (tVNS) on patients with fibromyalgia, a chronic pain condition. The study employs a double-blind, sham-controlled design to assess the efficacy of tVNS in reducing pain intensity and improving quality of life. Participants will receive stimulation through a device that targets the vagus nerve, which is believed to play a role in pain modulation and autonomic regulation. The trial aims to provide insights into a non-pharmacological treatment option for fibromyalgia, addressing the limitations of current therapies.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-79 diagnosed with fibromyalgia who experience moderate to high pain intensity.
Not a fit: Patients with significant cardiac arrhythmias or those unable to comply with the treatment regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective, and safe option for managing chronic pain in fibromyalgia patients.
How similar studies have performed: Previous studies on vagus nerve stimulation have shown promise in various conditions, suggesting potential for success in this novel application for fibromyalgia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Women between 18-79 years old * Women diagnosed with Fibromyalgia according to the ACR 2016 Revised Classification Criteria * Moderate to high pain intensity according to analog pain scales (above 4 points over 10), for more than 6 months * Cognitive function sufficient to understand the experiments and follow instructions * Ability to read and understand all information on the device display. * Ability to adjust the strength of the stimulation or give feedback regarding their response to the device (feeling tingling/pulsating/pain). * Ability to comply with the recommended therapy regiment of 30 min per day. * The ear electrode needs to fit the patient. * Patients with physical or mental disabilities * The patient must be able to use the device by themselves or * The patients' caretaker can operate the device on the patient. In this case the patient --must still be able to give feedback regarding their response to the device Exclusion Criteria * Cardiac arrhythmias * Pregnancy * Serious mental disorder (dipolar disorder, schizophrenia etc.) * Prior injury to the vagus nerve * Individuals with scar tissue that may interfere with the stimulation * Presence of an electrically or magnetically activated implant
Where this trial is running
Athens, Greece
- Aretaieion University Hospital — Athens, Greece, Greece (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.