Fibromyalgia, Pain
Conditions
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.
Interventions
Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactFelipe Fregni, MD, PhD, MPH
Backup ContactElly Pichardo, MD
Outcome results
None listed