Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 345
- 试验地点
- 2
- 主要终点
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity
研究概览
简要总结
Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain.
详细描述
Untreated PTSD appears to be a key risk factor for the transition from acute pain to chronic pain. Thus, reducing PTSD symptoms during an acute pain episode may potentially decrease the likelihood of transitioning to chronic pain. CPT is an evidence-based trauma-focused cognitive behavioral treatment that is hypothesized to reduce PTSD symptoms via reducing negative trauma-related cognitions about oneself, others, and the world. SGB treatment is an injection of a local anesthetic into the stellate ganglion, which is a bundle of nerves located at the base of the neck that is part of the sympathetic nervous system. Previous studies suggest that 1-week massed CPT and SGB treatment can both reduce the severity of PTSD symptoms in short periods of time via two distinct psychological and biological mechanisms.
This 4 year project will test study hypotheses in a sample of 345 individuals with PTSD symptoms who present to the presenting to the Rush University Medical Center ED or Rush's Primary Care and Preventive Medicine group with non-injury based acute pain. Participants will be randomly assigned to receive 1-week massed CPT, 2 SGB treatments, or usual care. All participants will complete identical self-report and/or clinician administered assessments at baseline (prior to randomization) and on study days 1, 7, 14, 21, 28, 56 (approximately 3 months after the initial ED presentation or Presentation to Preventive Medicine), and 112 (approximately 6 months after ED presentation or presentation to Preventive Medicine).
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Ability to read and write English sufficiently to understand and complete study questionnaires and participate in interviews
- •Presenting to the Rush ED with acute pain without debilitating trauma
- •A primary acute pain site
- •Self-reported symptoms consistent with a diagnosis of PTSD
- •People with well-controlled diabetes or HIV/AIDS with chronic neuropathic pain will be included if their acute pain complaint at ED presentation is not due to neuropathic pain
- •Individuals with a history of psychotic or bipolar disorder that is currently well managed, have been treated for the condition for at least 3 months, are able to coherently answer interview questions, and are judged by study staff to be capable of participating in study
- •Current chronic illness that involves constant or frequent pain if their acute pain complaint at ED presentation is not due to the chronic illness. (case-by-case basis)
- •Current chronic pain from various sources if their acute pain complaint at ED presentation is not related to their current chronic pain. (case-by-case basis)
排除标准
- •Pain intensity great enough to impair concentration or capacity to understand instructions or the nature of being invited into a study as assessed by a member of the medical staff
- •Any injury or illness that precludes their ability to understand or follow instructions as assessed by a member of the medical staff
- •Self-reported history of chronic pain on presentation to the ED or documented in the electronic medical record (case-by-case basis)
- •Pain from traumatic event that is the source of their PTSD
- •Neurological disorder
- •Blood pressure greater than 160/100 mmHg
- •Taking anticoagulants or antiplatelet drugs other than aspirin
- •Current alcohol or substance dependence
- •Anything that precludes interventions from being successful.
- •We will exclude people who are being treated for chronic or significant diseases such as rheumatoid disease, current influenza that may manifest temporary flu- related pain, and heart disease.
结局指标
主要结局
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity
时间窗: Through study completion, for an average of 6 months
Intensity of chronic pain reported by subject. The PROMIS Pain Intensity scale consists of 3 questions with a 5-point response scale ranging from "Had no pain" -to "Very severe. " Participants are asked how intense their pain has been in the past 7 days. Higher scores indicate more intense pain.
Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Self-Reported PTSD Symptoms
时间窗: Through study completion, for an average of 6 months
PCL-5 will be used to measure self-reported PTSD symptoms. The PCL-5 consists of 20 questions that ask how much a given symptom has bothered the participant within a specified time period. Each question has a 5 point response scale ranging from "not at all" (0) to "extremely" (4). Higher scores indicate greater PTSD symptom severity.
次要结局
- Change in AUDIT-C Self-Reported Substance Use(Through study completion, for an average of 6 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form)(Through study completion, for an average of 6 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance (short form)(Through study completion, for an average of 6 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference(Through study completion, for an average of 6 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)(Through study completion, for an average of 6 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety (short form)(Through study completion, for an average of 6 months)
- Change in SCID-5 mood and anxiety disorder diagnoses(Through study completion, for an average of 6 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anger (short form)(Through study completion, for an average of 6 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles(Through study completion, for an average of 6 months)