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
- 8
- 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
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)
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)
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 Functional Disability(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
- Change in Depressive symptoms(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)
- 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)
研究者
研究点 (8)
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