Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain (IMPROvE)

F

Frederiksberg University Hospital

Status

Completed

Conditions

Fibromyalgia
Chronic Widespread Pain

Treatments

Other: interdisciplinary rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT01352052
BDS-2011-099

Details and patient eligibility

About

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.

Full description

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.

Enrollment

192 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

192 participants in 2 patient groups

waiting list assignment
No Intervention group
Description:
6 months waiting list assignment followed by the 2-week interdisciplinary rehabilitation programme
Intervention: interdisciplinary rehabilitation programme
Active Comparator group
Description:
A two-weeks non-residential, group-based, psycho-educative treatment course conducted by an interdisciplinary team.
Treatment:
Other: interdisciplinary rehabilitation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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