SWIFT-RELIEVE : Simultaneous Treatment of Widespread Pain In Fibromyalgia and PTSD: Randomized Evaluation of Live vs. Inactive Electrical VNS With PE-PC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)]
研究概览
简要总结
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.
详细描述
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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All are blind except for the one study team member who is not involved in care who programs the device for the assigned condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
- •Subjects must speak English
- •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]
排除标准
- •Subjects must not have other primary clinical issues that would interfere with FM or PTSD treatment such as recent stroke or severe heart disease
- •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
- •Subjects must not have severe cognitive impairment that interferes with PE-PC (unable to retain information in acute interaction)
- •Subjects must not have unmanaged psychosis or bipolar disorder
- •Subjects must not have moderate to severe substance use disorder in the past 8 weeks
- •Subjects must not be currently receiving talk therapy for trauma-related symptoms or FM
- •Subjects must not be currently pregnant or lactating given risk of pre-term labor and interference of oxytocin with VNS effects
研究组 & 干预措施
taVNS plus PEPC
Transauricular vagus nerve stimulation (taVNS) 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.
干预措施: taVNS plus PEPC (Device)
结局指标
主要结局
Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)]
时间窗: 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)]
时间窗: 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)]
时间窗: 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).
次要结局
- PTSD Checklist for DSM 5 (PCL-5)(Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup)