GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Pain-related Fear and Avoidance
研究概览
简要总结
The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain at the Stanford Pediatric Pain Management Clinic (PPMC). The investigators will evaluate the effectiveness and acceptability of this intervention for children with high levels of pain-related fear and functional disability. If proven efficacious, it will allow for the dissemination of this innovative treatment model to others working with children and adolescents with chronic pain.
详细描述
The treatment intervention to be tested in this clinical trial is Graded in-vivo Exposure Treatment (GET Living) compared to Multidisciplinary Pain Management (MPM) in adolescents with chronic musculoskeletal pain. Participants will be randomized into GET Living or MPM, and will be instructed to not seek new treatments for pain for the duration of the study. Both treatments consist of 12 1-hour patient sessions delivered twice a week across 6- weeks and 3 parent-only sessions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 - 18 years old; Male or Female
- •Musculoskeletal pain (e.g. localized [back, limb], diffuse) not due to acute trauma (e.g. active sprain or fracture).
- •Moderate to high pain-related fear ( ≥ 35 on the FOPQ-C)
- •Moderate to high functional disability ( ≥ 13 on the FDI)
- •English Language Proficiency
排除标准
- •Significant cognitive impairment (e.g., brain injury)
- •Significant medical or psychiatric problem that would interfere (e.g., seizures, psychosis, suicidality)
结局指标
主要结局
Pain-related Fear and Avoidance
时间窗: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.
Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. The FOPQ-C contains two subscales: Fear of Pain (11 items; Min=0, Max=44) and Avoidance of Activities (13 items; Min=0, Max=52). Higher scores on each subscale indicate greater pain related fear and avoidance of activities.
次要结局
- Functional Disability(Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.)
研究者
Laura E Simons
Associate Professor
Stanford University