Effects of taVNS on Fibromyalgia Pain
ConditionFibromyalgia, Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpaulding Rehabilitation Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Older than 18 years old.
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).
must have the ability to feel sensation by Von-Frey fiber on the forearm.
Able to provide informed consent to participate in the study.
Disqualifiers
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.
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).
Presence of implanted cranial electronic medical devices (e.g., cochlear implants).
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).
Trial design
Treatments tested in this trial
- Transauricular vagus nerve stimulation (taVNS)
Treatment groups
152 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov