Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain (IMPROvE)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Oak Foundation
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01352052
First received: May 4, 2011
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Chronic Widespread Pain
Fibromyalgia
Other: interdisciplinary rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interdisciplinary Rehabilitation and Evaluation Programme for Patients With Chronic Widespread Pain: Randomized Controlled Trial, the IMPROvE Study

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Assessment of Motor and Process Skills (AMPS) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Disease severity scales;Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ] [ Designated as safety issue: No ]
  • Anxiety; Generalised Anxiety Disorder (GAD-10) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ] [ Designated as safety issue: No ]
  • Depression; Major Depression Inventory (MDI) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ] [ Designated as safety issue: No ]
  • Pain catastrophizing; Coping Strategy Questionnaire (CSQ) [ Time Frame: change from baseline at the end of intervention and at 6 months follow-up ] [ Designated as safety issue: No ]
  • Pain self-efficacy; Pain Self-Efficacy Questionnaire [ Time Frame: change from baseline at the end of treatment and at 6 months follow-up ] [ Designated as safety issue: No ]
  • Cognitive functioning; ISPOCD 2 test battery [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ] [ Designated as safety issue: No ]
  • Activity intolerance; The Measure of Functional Ability (Tiredness) [ Time Frame: change from baseline at the end of intervention and 6 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: May 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: waiting list assignment
6 months waiting list assignment followed by the 2-week interdisciplinary rehabilitation programme
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.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352052

Locations
Denmark
The Parker Institute, Frederiksberg University Hospital
Frederiksberg, Denmark, 2000
The Parker Institute, Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Oak Foundation
Investigators
Study Director: Bente Danneskiold-Samsøe, Professor The Parker Institute, Frederiksberg University Hospital
Principal Investigator: Kirstine Amris, MD The Parker Institute, Frederiksberg University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Bente Danneskiold-Samsøe, MD, DMSci, Professor, The Parker Institute, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01352052     History of Changes
Other Study ID Numbers: BDS-2011-099
Study First Received: May 4, 2011
Last Updated: May 10, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Frederiksberg University Hospital:
chronic widespread pain
fibromyalgia
outcome assessment
functional ability
AMPS
rehabilitation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014