Interdisciplinary Rehabilitation and Evaluation Programme for Patients With Chronic Widespread Pain: Randomized Controlled Trial, the IMPROvE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- SF-36 Mental Composite Score
研究概览
简要总结
The primary objective of the current study is to evaluate the outcome of an interdisciplinary multi-component rehabilitation programme customized to patients with chronic widespread pain (CWP) based on multidimensional diagnostic assessment including sub-grouping, and aiming to improve functional ability in everyday life. The hypothesis is that a patient-focused multi-disciplinary rehabilitation approach will improve both functional ability and quality of life for patients with CWP.
详细描述
Chronic widespread pain (CWP) is common in the general population and represents a major clinical challenge due to the complexity of the disorder. Apart from pain, CWP comprises a range of secondary features including non-restorative sleep, fatigue, cognitive dysfunction, emotionally distress and disability affecting daily life activities and health-related quality of life. CWP is strongly associated with incapacity for normal employment and poor social participation, and incurs high direct medical costs as well as significant indirect costs, e.g. sick-leave and disability compensation.
Currently there are no official recommendations concerning the diagnosing and management of patients suffering from CWP in the European health care system. The complexity of the condition underlines the necessity of a comprehensive multi-dimensional assessment and a patient-focused multi-component intervention.
The present study is a prospective, pragmatic randomized controlled trial (RCT), with blinded outcome assessors, aiming to evaluate the outcome of an interdisciplinary multi-component rehabilitation programme customized to patients with CWP and focusing on functional ability and adaptations in everyday life. 176 patients with CWP recruited from the department of rheumatology at Frederiksberg Hospital will be consecutively enrolled in the study over a 1-year period. Participants will be randomized to a 2-weeks non-residential, group-based, multi-component treatment course conducted by an interdisciplinary team or 6-months waiting list for the same course.
The instrumentation for intervention planning, as well as for outcome evaluation, will be based on an ICF measurement framework, as recommended by WHO and performance-based assessment of functional ability (AMPS) and self-reported, health-related quality of life (SF-36) will be applied as primary outcome measures.
Overall, the study results is expected to contribute to the development of more cost-effective health care strategies aiming at prevention of mal-adaptive illness behaviour and progressive functional loss in patients suffering from CWP.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age above 18
- •fulfills the American College of Rheumatology (ACR) 1990 classification criteria of widespread musculoskeletal pain i.e. reporting of pain axially and in all 4 body quadrants for a minimum duration of 3 months
- •willing to participate in a 2-week group-based rehabilitation programme
排除标准
- •severe physical impairment necessitating assistance in personal activities of daily living
- •concurrent history of major psychiatric disorder not related to the pain disorder
- •other medical conditions capable of causing patients symptoms (e.g. uncontrolled inflammatory/autoimmune disorder, uncontrolled endocrine disorder, malignancy)
- •not Danish speaking
- •enrollment in any other clinical trial within the last 30 days
结局指标
主要结局
SF-36 Mental Composite Score
时间窗: change from baseline at the end of intervention and 6 months follow-up
Assessment of Motor and Process Skills (AMPS)
时间窗: change from baseline at the end of intervention and 6 months follow-up
The Assessment of Motor and Process Skills (AMPS) is a performance-based evaluation of ADL ability, developed to establish the extent of an individual's ability to perform and complete daily life tasks independently and in a safe and efficient manner. Further, the AMPS measurement model incorporates the use of Rasch analysis, and therefore provides equal-interval linear measures of the quality of ADL task performances. Two separate measures are reported, one for ADL motor ability (moving self and objects) and one for ADL process ability (organising and adapting actions).
次要结局
- Anxiety; Generalised Anxiety Disorder (GAD-10)(change from baseline at the end of intervention and 6 months follow-up)
- Cognitive functioning; ISPOCD 2 test battery(change from baseline at the end of intervention and 6 months follow-up)
- Health related quality of life scales; Short-Form-36 Health Survey (SF-36)(change from baseline at the end of intervention and 6 months follow-up)
- Disease severity scales;Fibromyalgia Impact Questionnaire (FIQ)(change from baseline at the end of intervention and 6 months follow-up)
- Depression; Major Depression Inventory (MDI)(change from baseline at the end of intervention and 6 months follow-up)
- Pain catastrophizing; Coping Strategy Questionnaire (CSQ)(change from baseline at the end of intervention and at 6 months follow-up)
- Pain self-efficacy; Pain Self-Efficacy Questionnaire(change from baseline at the end of treatment and at 6 months follow-up)
- Activity intolerance; The Measure of Functional Ability (Tiredness)(change from baseline at the end of intervention and 6 months follow-up)
研究者
Henning Bliddal
Professor
Frederiksberg University Hospital