taVNS Treatment for Fibromyalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular transcutaneous electrical nerve stimulation device.
- Who it may be relevant to
- Registry conditions: Fibromyalgia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia
Overview
In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.
Interventions
- Device Auricular transcutaneous electrical nerve stimulation device
We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.
Primary outcome measures
- Revised Fibromyalgia Impact Questionnaire (FIQR) [Time frame: Baseline, week 2 and week 4.]
Secondary outcome measures (7)
- Patient Reported Outcomes Measurement Information System (PROMIS-29) [Time frame: Baseline, week 2 and week 4.]
- Pain Catastrophizing Scale [Time frame: Baseline, week 2 and week 4.]
- Beck Depression Inventory-II (BDI-II) [Time frame: Baseline and week 4.]
- Brief Quantitative Sensory Testing (QST) [Time frame: Baseline and week 4.]
- Heart rate variability [Time frame: Baseline and week 4.]
- power of oscillations in the alpha, theta, and gamma frequencies (optional) [Time frame: Baseline and week 4.]
- Blood inflammation markers (optional) [Time frame: Baseline and week 4]
Eligibility criteria
Inclusion criteria
- Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
- Willingness to complete a 4-week, twice-a-day treatments.
- At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Exclusion criteria
- Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome.
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
- Personal history of medical or psychiatric illness as determined by investigator.
- Pregnant or lactating.
- Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Charlestown
Identifiers
NCT: NCT04777500 · 2020P003800