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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Revised Fibromyalgia Impact Questionnaire (FIQR)
A change in the FIQR would indicate that participants are experiencing pain relief.
Time frame: Baseline, week 2 and week 4.
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)
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.
Time frame: 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.
Time frame: Baseline and week 4
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