NCT02181725已完成不适用
Effectiveness and Cost-effectiveness of a Multimodal Rehabilitation Programme (MRP) for Adolescents With Chronic Musculoskeletal Pain (12-21 Years) Compared to Care as Usual (CAU); a Randomized Clinical Trial (2B Active)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Functional Disability
研究概览
简要总结
The purpose of this study is to evaluate whether a multimodal rehabilitation program effectively reduces functional disability in adolescents with chronic musculoskeletal pain, compared to care as usual.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-21 years at the start of the study
- •Complaints of chronic non-specific musculoskeletal pain of a duration > 3 months
- •Considerable activity limitations
- •Fear of movement
- •Indication for outpatient multidisciplinary rehabilitation treatment
- •Adequate Dutch literacy to complete the assessments (which mainly comprise questionnaires)
排除标准
- •Any suspicion of a medical (orthopaedic, rheumatic or neurological) disease, that can explain the current pain complaints
- •Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.
- •Pregnancy
研究组 & 干预措施
Multimodal Rehabilitation Program
Experimental
Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM)
干预措施: Multimodal Rehabilitation Program (Behavioral)
Care as Usual
Active Comparator
Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
干预措施: Care as Usual (Behavioral)
结局指标
主要结局
Change in Functional Disability
时间窗: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported functional disability
次要结局
- Change in Depressive symptoms(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Change in Fear of Pain(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Change in Pain Catastrophizing(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Treatment expectations(Baseline)
- Cost-diary per month(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Change in Functional Disability(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Change in Pain Intensity(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Change in General Health Related Quality of Life(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Treatment satisfaction/ patient centeredness(16 weeks)
- Change in Quality of life(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Change in parental responses to childrens pain(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Treatment satisfaction/ family centeredness(16 weeks)
- Change in Perceived Harmfulness(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
研究者
研究点 (4)
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