Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Roland-Morris Disability Questionnaire
研究概览
简要总结
The purpose of this study is to determine if a stepped-care intervention makes pain symptoms better and reduces activity limitations because of pain. Our two primary hypotheses are that in OIF/OEF veterans with chronic pain:
- Stepped care is more effective than usual care in reducing pain-related disability
- Stepped care is more effective than usual care in reducing psychological distress
详细描述
Through the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial we aim to develop and test a stepped-care intervention to improve functional and work-related outcomes in Operation Iraqi Freedom/Operation Enduring Freedom veterans with chronic musculoskeletal pain. Stepped-care involves starting with lower intensity, less costly treatments initially (Step 1) and "stepping up" to more intensive, costly, or complex treatments in patients with inadequate response (Step 2). The study design will be a randomized controlled trial. The stepped care approach will involve 12 weeks of a pain self-management program in Step 1 followed by 12 weeks of brief cognitive behavioral therapy in participants with inadequate improvement in pain-related disability (Step 2). Patients treated in usual care will be the control group. Thus, the primary objective of the ESCAPE trial is to conduct a randomized controlled trial to compare the effectiveness of a stepped care intervention vs. usual care in OIF/OEF veterans with chronic and disabling musculoskeletal pain and evaluate the impact of this intervention on pain-related disability, work function, psychological distress, and secondary outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have musculoskeletal pain of the low back, cervical spine, or extremities
- •have chronic pain (>3 months duration)
- •have moderate functional impairment
- •have access to a working telephone
- •Indianapolis Roudebush VA Medical Center patient or Walter Reed Army Medical Center patient
- •willing to travel at least once to study site
排除标准
- •prior back or cervical spine surgery or surgery pending
- •active psychosis
- •incompetent for interview
- •severe impairment of hearing or speech
- •active suicidal ideation
- •current alcohol or other substance dependence or abuse
研究组 & 干预措施
Stepped Care
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
干预措施: Cognitive behavioral therapy (Behavioral)
Stepped Care
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
干预措施: Pain self-management program (Behavioral)
Stepped Care
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
干预措施: Co-Analgesic Therapy (Drug)
Stepped Care
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
干预措施: Opioid Analgesics (Drug)
结局指标
主要结局
Roland-Morris Disability Questionnaire
时间窗: at baseline and 9 months
This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.
Brief Pain Inventory (Interference)
时间窗: Baseline and 9 months
This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents "no interference" and 10 is "completely interferes". The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7).
次要结局
- SF-Mental Component Summary (MCS)(Baseline and 9 months)
- PHQ-9 Depression(Baseline and 9 months)
- PTSD Checklist-17 Civilian Version (PCL-C)(Baseline and 9 months)
- GAD-7 Anxiety Score(Baseline and 9 months)
- Pain Catastrophizing Scale (PCS)(Baseline and 9 months)