Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain

Fibromyalgia Clinical Trial

— IMPROvE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352052
• Other study ID #: BDS-2011-099
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: August 9, 2016
• Start date: May 2011
• Est. completion date: January 2014

Study information

• Verified date: August 2016
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Widespread Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Frederiksberg
Denmark	The Parker Institute, Frederiksberg University Hospital	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
Frederiksberg University Hospital	Oak Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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):664-9. doi: 10.1016/j.pain.2010.08.023. Epub 2010 Sep 15. — View Citation

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. Epub 2007 Jan 25. — View Citation

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):535-41. doi: 10.1016/j.pain.2010.06.008. Epub 2010 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	SF-36 Mental Composite Score		change from baseline at the end of intervention and 6 months follow-up	No
Secondary	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	No
Secondary	Disease severity scales;Fibromyalgia Impact Questionnaire (FIQ)		change from baseline at the end of intervention and 6 months follow-up	No
Secondary	Anxiety; Generalised Anxiety Disorder (GAD-10)		change from baseline at the end of intervention and 6 months follow-up	No
Secondary	Depression; Major Depression Inventory (MDI)		change from baseline at the end of intervention and 6 months follow-up	No
Secondary	Pain catastrophizing; Coping Strategy Questionnaire (CSQ)		change from baseline at the end of intervention and at 6 months follow-up	No
Secondary	Pain self-efficacy; Pain Self-Efficacy Questionnaire		change from baseline at the end of treatment and at 6 months follow-up	No
Secondary	Cognitive functioning; ISPOCD 2 test battery		change from baseline at the end of intervention and 6 months follow-up	No
Secondary	Activity intolerance; The Measure of Functional Ability (Tiredness)		change from baseline at the end of intervention and 6 months follow-up	No