Fibromyalgia (FM), Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
fibromyalgia, post-traumatic stress disorder, pain, heart rate variability, vagus nerve stimulation, treatment
Brief summary
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.
Detailed description
The investigators' goal is to test whether providing simultaneous non-drug treatments for both FM and PTSD improves symptom impact on both conditions. taVNS, a non-invasive neuromodulatory technique applied to the auricular branch of the vagus nerve, 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, taVNS 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 taVNS 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) taVNS for pain + PE-PC or 2) sham taVNS + PE-PC. taVNS 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) taVNS+PE-PC and 2) sham taVNS+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: taVNS+PE-PC will result in larger reductions in pain interference and intensity than sham taVNS+PE-PC (\[Baseline\] to Week 4). Differences will be maintained at \[4-month follow-up\]. Hypothesis 1b: taVNS+PE-PC will result in larger reductions in PTSD severity than sham taVNS+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 taVNS+PE-PC and sham taVNS+PE-PC. Exploratory Hypothesis: taVNS+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.
Interventions
DEVICEtaVNS plus PEPC
The research version of Spark's Sparrow Ascent for vagus 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.
DEVICEsham plus PEPC
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All are blind except for the one study team member who is not involved in care who programs the device for the assigned condition.
Intervention model description
Veterans are randomly assigned to receive active or sham taVNS for the treatment phase (4 weeks) and then all Veterans are allowed to receive active taVNS for 4 weeks All veterans receive PEPC for the first 4 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be any era Veterans reporting FM and PTSD symptoms (PTSD Checklist for DSM-5 (PCL-5) ≥ 28; FM confirmed with ACR Diagnostic Criteria and pain score at least 4/10 for 3 months \[94\] 2. Subjects must speak English 3. If subjects are taking psychotropic medication, 2-weeks on stable dose prior to enrollment and agreement to maintain current medications until after the \[4-month follow-up visit\]
Exclusion criteria
1. Subjects must not have other primary clinical issues that would interfere with FM or PTSD treatment such as recent stroke or severe heart disease 2. Subjects must not have a level of suicide risk that requires intervention as determined by item 9 on PHQ-9 with follow-up risk assessment by study staff 3. Subjects must not have severe cognitive impairment that interferes with PE-PC (unable to retain information in acute interaction) 4. Subjects must not have unmanaged psychosis or bipolar disorder 5. Subjects must not have moderate to severe substance use disorder in the past 8 weeks 6. Subjects must not be currently receiving talk therapy for trauma-related symptoms or FM 7. Subjects must not be currently pregnant or lactating given risk of pre-term labor and interference of oxytocin with VNS effects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)] | Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup | Single item rating past week average intensity of pain on a scale from 0 (none) to 10 (As bad as I can imagine) |
| Pain Interference with Enjoyment [Pain, Enjoyment, and General Activity Scale (PEG)] | Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup | Single item rating of average pain interference with enjoyment of life over the past week on a 0 (no interference) to 10 (completely interfered). |
| Pain Interference with Activity [Pain, Enjoyment, and General Activity Scale (PEG)] | Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup | Single item rating of average pain interference in general activity over the past week on a 0 (no interference) to 10 (completely interfered). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM 5 (PCL-5) | Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup | 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. |
Countries
United States
Contacts
CONTACTSheila A Rauch, PhD
CONTACTAnna Woodbury, MD
PRINCIPAL_INVESTIGATORSheila A.M. Rauch, PhD
Atlanta VA Medical and Rehab Center, Decatur, GA
PRINCIPAL_INVESTIGATORAnna Woodbury, MD
Atlanta VA Medical and Rehab Center, Decatur, GA
Outcome results
None listed