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Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC

Study acronym: SWIFT-RELIEVE
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions modified Eligibility criteria expanded, about 21 words · Secondary endpoint revised · Site contact updated · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoint revised
    • Site contact updated
    • Study description expanded, about 2 words
  2. Phase changed: Phase 3 → not applicable Interventions: sham (Device), taVNS plus PEPC (Device) to sham plus PEPC (Device), taVNS plus PEPC (Device)v2 Show 1 more changeShow less
    • Interventions: sham (Device), taVNS plus PEPC (Device) to sham plus PEPC (Device), taVNS plus PEPC (Device)
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 \[transauricular nerve stimulation (tAN)\] 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 tAN for pain + Prolonged Exposure in Primary Care (PE-PC) and 2) sham tAN + 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.
Trial Details
NCT Number NCT07718984
Lead Sponsor VA Office of Research and Development
Conditions Fibromyalgia (FM), Posttraumatic Stress Disorder (PTSD)
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov