ReActivate: Physiotherapist Led Intervention for Adolescents and Young Adults With Musculoskeletal Pain; A Sequential Replicated and Randomized Single Case Experimental Design (SCED)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Activity engagement change
研究概览
简要总结
Recurrent or persistent musculoskeletal pain is an alarmingly common problem among adolescents, in Sweden as well as globally. Pain often co-occur with and psychological distress and have both been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent musculoskeletal pain and based upon graded exposure to physical activity and reactivation.
详细描述
See description of arms and intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-25
- •Persistent (consistently or weekly recurrent) musculoskeletal pain problems for ≥3 months, with pain intensity ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)
- •Presence of avoidance behaviour and/or or worry about symptoms/problems, ≥1 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent); > 50 on at least one activity of the PHODA.
- •Swedish speaking and able to fill out questionnaires
排除标准
- •Serious/malignant disease
- •Participation in other rehabilitation program
- •Severe mental health problems
- •Substance abuse
- •Severe learning disabilities
研究组 & 干预措施
No treatment waiting period
Participants are randomized to a 7, 14 or 21 day waiting period. Daily measurements are collected throughout this period.
Reactivate
Reactivate treatment. Daily measurements are collected throughout treatment.
干预措施: Reactivate (Behavioral)
结局指标
主要结局
Activity engagement change
时间窗: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention
Change in self-rated activity engagement. Numerical Rating Scale, range 0-6 (1 question: lower values, worse outcome, 1 question: Lower values, better outcome )
Symptom distress change
时间窗: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention.
Change in self-rated distress about symptoms. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome)
次要结局
- Change in psychological distress(repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.)
- Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change(baseline, after treatment phase B (12 weeks), 6 months after terminated intervention)
- Functional Disability Inventory (FDI) change(baseline, after treatment phase B (12 weeks), 6 months after terminated intervention)
- Center of Epidemiological Studies Depression Scales for Children (CES-DC) change(baseline, after treatment phase B (12 weeks), 6 months after terminated intervention)
- The Pediatric Quality of Life Acute version (PedsQL) PedsQL™(baseline, after treatment phase B (12 weeks), 6 months after terminated intervention)
- The Photograph Series of Daily Activities for youth (PHODA) change - short(First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks))
- Pain change(repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.)