An interventional study of tAN plus PEPC and sham plus PEPC in Fibromyalgia (FM) and Posttraumatic Stress Disorder (PTSD), sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
The investigators' goal is to test whether providing simultaneous non-drug treatments for both FM and PTSD improves symptom impact on both conditions. tAN, a non-invasive neuromodulatory technique applied to the auricular branch of the vagus and trigeminal nerves, has preliminary efficacy in reducing chronic pain and reducing PTSD severity in Veterans with PTSD and in an opioid withdrawal population. PE-PC is a form of Prolonged Exposure, a gold standard treatment for PTSD, that is designed for integrated care and effectively reduces PTSD severity. In addition, tAN applied with the proposed device significantly reduced PCL-5 scores by 35% from baseline to Day 5 in adults withdrawing from opioid. Within this high-risk comorbid population, adding a non-opioid pain intervention provided within the context of effective PTSD treatment promises to increase impact 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 standard care. Study results can inform implementation for this combined intervention and speed its use in clinics. Thus, more Veterans will have access to effective care for FM and PTSD, supporting a priority of POU-AMP and the VA National Strategy for Preventing Suicide (2018). In summary, the investigators will examine whether pain is reduced with PTSD treatment in FM, and whether addition of tAN can augment this effect compared to sham.
Design: The investigators will randomize 180 Veterans with co-morbid FM and PTSD from across AVAHCS to receive: 1) tAN for pain + PE-PC or 2) sham tAN + PE-PC. tAN administered daily for 2 hours for 4 weeks. PE-PC is provided in six 30-minute sessions up 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 Fibromyalgia Impact Questionnaire Revised (FIQR), Polysymptomatic Distress Scale (PSD), PTSD (PCL-5 weekly 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-related pain interference and intensity in the context of PE-PC for PTSD [Primary Outcome: PEG scale and PTSD symptom severity [Secondary Outcome: PCL5, weekly].
Hypothesis 1a: tAN+PE-PC will result in larger reductions in pain interference and intensity 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 sham tAN+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 of response associated with FM-related pain and PTSD severity improvement in tAN+PE-PC and sham tAN+PE-PC.
Exploratory Hypothesis: tAN+PE-PC will result in greater change in HRV compared to sham+PE-PC. This proposal targets the Pain and Opioid Use Actively Managed Portfolio (POU-AMP) research priority of pragmatic clinical trials for treatment of painful conditions using non-pharmacological approaches. The long-term objective is improving Veteran health through focused combined intervention for FM and PTSD.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transauricular nerve stimulation (tAN) provided for 2 hours per day for weeks. Frequency: 25 Hz on inner region (ABVN), 100Hz on outer region (ATN), Pulse width: 250 µs, Duty cycle: 5 minutes on, 10 second off. Stimulation is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Device: tAN plus PEPC
Sham will use the same device and schedule with a brief individualized suprasensory stimulation followed by a ramp down over 2 minutes. Sham is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Device: sham plus PEPC
The research version of Spark's Sparrow Ascent for vagus and trigeminal nerve stimulation provided through a sticker that attaches to the ear. This device allows the patient to self apply the device in a home setting. It is FDA cleared and available in VA. Stimulation is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Also known as: Sparrow Link
Same device as active condition but programmed with sham parameters including suprasensory stimulation followed by ramp down. Sham is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Also known as: Sparrow Link
Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)]
Single item rating past week average intensity of pain on a scale from 0 (none) to 10 (As bad as I can imagine)
Time frame: Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup
Pain Interference with Enjoyment [Pain, Enjoyment, and General Activity Scale (PEG)]
Single item rating of average pain interference with enjoyment of life over the past week on a 0 (no interference) to 10 (completely interfered).
Time frame: Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup
Pain Interference with Activity [Pain, Enjoyment, and General Activity Scale (PEG)]
Single item rating of average pain interference in general activity over the past week on a 0 (no interference) to 10 (completely interfered).
Time frame: Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup
Post-traumatic stress disorder (PTSD) Checklist for DSM 5 (PCL-5)
Total sum of each of 20 items covering PTSD symptom ratings for the past week each scored on a 0 (not al all) to 4 (extremely) scale. Total score ranges from 0 to 80.
Time frame: Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup
Plan to share: Yes — A deidentified dataset will be available with publication per policy of the journal on publication or upon appropriate request after all primary statement of work analyses are published.
Supporting information: Study protocol, Informed consent form
Time frame: Upon publication if required and after publication of all primary statement of work analyses upon appropriate request.
Access criteria: Data will available from request to the principal investigator after all publications are released.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2030, 47 months later.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 47 months is above that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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