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Completed

NCT Number: NCT01352052

Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain

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.

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Key information

Conditions

Chronic Widespread Pain Chronic Pain Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Parker Institute, Frederiksberg Hospital, Frederiksberg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interdisciplinary rehabilitation

Other

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.

Primary outcomes

  1. 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).

  2. SF-36 Mental Composite Score

    Time frame: change from baseline at the end of intervention and 6 months follow-up

Secondary outcomes

  1. 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

  2. Disease severity scales;Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: change from baseline at the end of intervention and 6 months follow-up

  3. Anxiety; Generalised Anxiety Disorder (GAD-10)

    Time frame: change from baseline at the end of intervention and 6 months follow-up

  4. Depression; Major Depression Inventory (MDI)

    Time frame: change from baseline at the end of intervention and 6 months follow-up

  5. Pain catastrophizing; Coping Strategy Questionnaire (CSQ)

    Time frame: change from baseline at the end of intervention and at 6 months follow-up

  6. Pain self-efficacy; Pain Self-Efficacy Questionnaire

    Time frame: change from baseline at the end of treatment and at 6 months follow-up

  7. Cognitive functioning; ISPOCD 2 test battery

    Time frame: change from baseline at the end of intervention and 6 months follow-up

  8. Activity intolerance; The Measure of Functional Ability (Tiredness)

    Time frame: change from baseline at the end of intervention and 6 months follow-up

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Collaborators

  • Oak Foundation

Registry information

Official study title

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

Acronym: IMPROvE

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 11, 2011
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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