Fibromyalgia
Conditions
Keywords
taVNS, Pain, Neuromodulation, Fibromyalgia
Brief summary
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
DEVICEAuricular transcutaneous electrical nerve stimulation device
We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.
Sponsors
Massachusetts General 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 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQR) | Baseline, week 2 and week 4. | A change in the FIQR would indicate that participants are experiencing pain relief. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS-29) | Baseline, week 2 and week 4. | — |
| Pain Catastrophizing Scale | Baseline, week 2 and week 4. | — |
| Beck Depression Inventory-II (BDI-II) | Baseline and week 4. | — |
| Brief Quantitative Sensory Testing (QST) | Baseline and week 4. | — |
| Heart rate variability | Baseline and week 4. | — |
| power of oscillations in the alpha, theta, and gamma frequencies (optional) | Baseline and week 4. | 6 minutes of resting state EEG (with eyes open) (Optional). We will calculate the power of oscillations in the alpha, theta, and gamma frequencies, which will be normalized by the mean power for the global spectrum. |
| Blood inflammation markers (optional) | Baseline and week 4 | We will examine inflammatory mediators such as interleukins (ILs including IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, and IL-10), IFN-γ, and tumor necrosis factor (TNF) via multiplex immunoassays using Luminex, as well as highly sensitive C-reactive protein (hsCRP), programmed death 1 (PD-1), prostaglandin E2, and BDNF. |
Countries
United States
Contacts
CONTACTMaya Eshel, BA
PRINCIPAL_INVESTIGATORJian Kong
MGH
Outcome results
None listed