Fibromyalgia (FM) pain and PTSD are highly prevalent and comorbid with associated increased risk of negative physical and mental health outcomes, including higher risk for opioid use and suicide. This project is designed to determine the effects of a 4 week trial of a device for pain management \[transauricular vagus nerve stimulation (taVNS)\] on pain interference and intensity \[Pain, Enjoyment, and Activity General Scale (PEG)\] and PTSD. The investigators will also examine how this impacts the Veterans by examining heart rate variability (HRV) as a stress response related biomarker. The investigators plan to randomize 180 Veterans (estimate up to 360 enrolled) with co-morbid FM and PTSD across pain integrated care and PTSD sites in this prospective study and compare: 1) active taVNS for pain + Prolonged Exposure in Primary Care (PE-PC) and 2) sham taVNS + PE-PC. Study includes 4 weeks of randomized treatment and 4 weeks of voluntary open label treatment. Veterans are assessed (self report \& interview measures, heart rate variability by wearable device) at Intake, Baseline/Post Run-In, Week 2, Week 4, Week 8 and 4 month follow-up. The investigators plan to retain data after the study for potential future use in research.
Age range
18 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)]
Timeframe: Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup
Pain Interference with Enjoyment [Pain, Enjoyment, and General Activity Scale (PEG)]
Timeframe: Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup
Pain Interference with Activity [Pain, Enjoyment, and General Activity Scale (PEG)]
Timeframe: Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup