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

The investigators' goal is to test whether providing simultaneous non‐drug treatments forboth FM and PTSD improves symptom impact on both conditions. tAN, a non‐invasiveneuromodulatory technique applied to the auricular branch of the vagus and trigeminalnerves, has preliminary efficacy in reducing chronic pain and reducing PTSD severity inVeterans with PTSD and in an opioid withdrawal population. PE‐PC is a form of ProlongedExposure, a gold standard treatment for PTSD, that is designed for integrated care andeffectively reduces PTSD severity. In addition, tAN applied with the proposed devicesignificantly reduced PCL‐5 scores by 35% from baseline to Day 5 in adults withdrawingfrom opioid. Within this high‐risk comorbid population, adding a non‐opioid painintervention provided within the context of effective PTSD treatment promises to increaseimpact on both pain and PTSD. The combination requires minimal additional 'in clinic'time, may be provided in‐home or via telehealth, and each is available in VA standardcare. Study results can inform implementation for this combined intervention and speedits use in clinics. Thus, more Veterans will have access to effective care for FM andPTSD, supporting a priority of POU‐AMP and the VA National Strategy for PreventingSuicide (2018). In summary, the investigators will examine whether pain is reduced withPTSD treatment in FM, and whether addition of tAN can augment this effect compared tosham.Design: The investigators will randomize 180 Veterans with co‐morbid FM and PTSD fromacross AVAHCS to receive: 1) tAN for pain + PE‐PC or 2) sham tAN + PE‐PC. tANadministered daily for 2 hours for 4 weeks. PE‐PC is provided in six 30‐minute sessionsup to 3 times per week. Assessments will be collected at Intake, Baseline/Post Run‐In,Week 2, Week 4, and [4 month follow‐up]. Primary outcome will be posttreatment (week 4)Pain, Enjoyment and General Activity Scale (PEG). Secondary outcomes include FibromyalgiaImpact Questionnaire Revised (FIQR), Polysymptomatic Distress Scale (PSD), PTSD (PCL‐5weekly version). Biomarker analysis will examine the association of HRV [(baseline &trauma cued).Aim (1): Examine additive efficacy of 1) tAN+PE‐PC and 2) sham tAN+PE‐PC on FM‐relatedpain interference and intensity in the context of PE‐PC for PTSD [Primary Outcome: PEGscale and PTSD symptom severity [Secondary Outcome: PCL5, weekly].Hypothesis 1a: tAN+PE‐PC will result in larger reductions in pain interference andintensity than sham tAN+PE‐PC ([Baseline] to Week 4). Differences will be maintained at[4‐month follow‐up].Hypothesis 1b: tAN+PE‐PC will result in larger reductions in PTSD severity than shamtAN+PE‐PC ([Baseline] to Week 4). Differences will be maintained at [4‐month follow‐up].Exploratory Aim: Evaluate changes in HRV (baseline & trauma cued) as a biomarker ofresponse associated with FM‐related pain and PTSD severity improvement in tAN+PE‐PC andsham tAN+PE‐PC.Exploratory Hypothesis: tAN+PE‐PC will result in greater change in HRV compared tosham+PE‐PC. This proposal targets the Pain and Opioid Use Actively Managed Portfolio(POU‐AMP) research priority of pragmatic clinical trials for treatment of painfulconditions using non‐pharmacological approaches. The long‐term objective is improvingVeteran health through focused combined intervention for FM and PTSD.