Effects of TaVNS on Fibromyalgia Pain

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia, Pain
• Interventions: Device: Transauricular vagus nerve stimulation (taVNS)

• Registration Number: NCT06193317
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

Transauricular vagus nerve stimulation (taVNS) is a newer delivery system, using a non-invasive stimulation device placed at the ear's concha. TaVNS is a portable, safe, and low-cost intervention, and according to some studies, taVNS may influence nociception and pain perception, which can lead to potential applications for various painful illnesses, including fibromyalgia (FM). This trial aims to investigate the clinical effects of taVNS on pain control in FM subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Study Start: 2025-06-01
• Primary Completion: 2027-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1. Older than 18 years old.
2. Diagnosis of FM pain according to the American College of Rheumatology (ACR) 2010 criteria (existing pain for more than six months with an average of at least 3 on a 0-10 VAS scale).
3. must have the ability to feel sensation by Von-Frey fiber on the forearm.
4. Able to provide informed consent to participate in the study.

Exclusion Criteria

1. Subjects who have unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease) or who have functional deficits, as self-reported.
2. history of substance abuse within the past six months as self-reported (if the subject reports a history of substance abuse, we will confirm using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria).
3. Presence of implanted cranial electronic medical devices (e.g., cochlear implants).
4. pregnancy (as the safety of taVNS in the pregnant population (and children) has not been assessed (though the risk is non-significant), we will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and every two weeks of stimulation).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham taVNS	Transauricular vagus nerve stimulation (taVNS)	Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min for 16 sessions there will be no current and the device will be turned off.
Active taVNS	Transauricular vagus nerve stimulation (taVNS)	TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hertz (Hz), 200-250 us, and with adjustable intensity for 60 min for 16 sessions.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Spaulding Hospital Cambridge; 🇺🇸 Cambridge, Massachusetts, United States