Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain (IMPROvE)
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|ClinicalTrials.gov Identifier: NCT01352052|
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment|
|Chronic Widespread Pain Fibromyalgia||Other: interdisciplinary rehabilitation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Interdisciplinary Rehabilitation and Evaluation Programme for Patients With Chronic Widespread Pain: Randomized Controlled Trial, the IMPROvE Study|
|Study Start Date :||May 2011|
|Primary Completion Date :||January 2014|
|Study Completion Date :||January 2014|
No Intervention: waiting list assignment
6 months waiting list assignment followed by the 2-week interdisciplinary rehabilitation programme
Active Comparator: Intervention: interdisciplinary rehabilitation programme
A two-weeks non-residential, group-based, psycho-educative treatment course conducted by an interdisciplinary team.
Other: interdisciplinary rehabilitation
A two-weeks non-residential, group-based, psycho-educative, multi-component treatment course conducted by an interdisciplinary team consisting of a rheumatologist, a nurse, occupational therapists, physical therapists, and a psychologist. The rehabilitation Programme comprises of a combination of lectures and group discussions, as well as instructions during physical exercise and task performance. The main focus is on education and adaptations in everyday life. There is a scheduled Programme for every day, with a daily time schedule between four and six hours. There will be a maximum of eight participants in each group.
- Assessment of Motor and Process Skills (AMPS) [ Time Frame: 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).
- SF-36 Mental Composite Score [ Time Frame: 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) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ]
- Disease severity scales;Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ]
- Anxiety; Generalised Anxiety Disorder (GAD-10) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ]
- Depression; Major Depression Inventory (MDI) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ]
- Pain catastrophizing; Coping Strategy Questionnaire (CSQ) [ Time Frame: change from baseline at the end of intervention and at 6 months follow-up ]
- Pain self-efficacy; Pain Self-Efficacy Questionnaire [ Time Frame: change from baseline at the end of treatment and at 6 months follow-up ]
- Cognitive functioning; ISPOCD 2 test battery [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ]
- Activity intolerance; The Measure of Functional Ability (Tiredness) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352052
|The Parker Institute, Frederiksberg Hospital|
|Frederiksberg, Denmark, 2000|
|The Parker Institute, Frederiksberg University Hospital|
|Frederiksberg, Denmark, 2000|
|Study Director:||Bente Danneskiold-Samsøe, Professor||The Parker Institute, Frederiksberg University Hospital|
|Principal Investigator:||Kirstine Amris, MD||The Parker Institute, Frederiksberg University Hospital|