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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS Group1 | Experimental | This group will receive taVNS for 4 weeks. |
|
| taVNS Group 2 | Experimental | This group will receive taVNS for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular transcutaneous electrical nerve stimulation device | Device | We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQR) | A change in the FIQR would indicate that participants are experiencing pain relief. | Baseline, week 2 and week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS-29) | Baseline, week 2 and week 4. | |
| Pain Catastrophizing Scale | Baseline, week 2 and week 4. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Eshel, BA | Contact | (617) 726-5004 | meshel@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jian Kong | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129-2020 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| 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) | 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. | Baseline and week 4. |
| Blood inflammation markers (optional) | 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. | Baseline and week 4 |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |