Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain (IMPROvE)

Interdisciplinary Rehabilitation and Evaluation Programme for Patients With Chronic Widespread Pain: Randomized Controlled Trial, the IMPROvE Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Widespread Pain; Fibromyalgia
• Intervention / Treatment: Other: interdisciplinary rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • The Parker Institute, Frederiksberg Hospital
  • Frederiksberg, Denmark, 2000
    • The Parker Institute, Frederiksberg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Motor and Process Skills (AMPS)	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).	change from baseline at the end of intervention and 6 months follow-up
SF-36 Mental Composite Score		change from baseline at the end of intervention and 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Anxiety; Generalised Anxiety Disorder (GAD-10)	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
Cognitive functioning; ISPOCD 2 test battery	change from baseline at the end of intervention and 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

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Collaborators: 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

Publications and helpful links

General Publications

• Jespersen A, Dreyer L, Kendall S, Graven-Nielsen T, Arendt-Nielsen L, Bliddal H, Danneskiold-Samsoe B. Computerized cuff pressure algometry: A new method to assess deep-tissue hypersensitivity in fibromyalgia. Pain. 2007 Sep;131(1-2):57-62. doi: 10.1016/j.pain.2006.12.012. Epub 2007 Jan 25.
• Amris K, Jespersen A, Bliddal H. Self-reported somatosensory symptoms of neuropathic pain in fibromyalgia and chronic widespread pain correlate with tender point count and pressure-pain thresholds. Pain. 2010 Dec;151(3):664-669. doi: 10.1016/j.pain.2010.08.023. Epub 2010 Sep 15.
• Waehrens EE, Amris K, Fisher AG. Performance-based assessment of activities of daily living (ADL) ability among women with chronic widespread pain. Pain. 2010 Sep;150(3):535-541. doi: 10.1016/j.pain.2010.06.008. Epub 2010 Jul 3.

Helpful Links

• Web page of the Parker Institute, Frederiksberg University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: May 4, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: rehabilitation; fibromyalgia; functional ability; outcome assessment; chronic widespread pain; AMPS
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Chronic Pain; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: BDS-2011-099