Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 22 August 2016
• Main ID: NCT01352052
• Date of registration: 04/05/2011
• Prospective Registration: No
• Primary sponsor: Frederiksberg University Hospital
• Public title: Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain IMPROvE
• Scientific title: Interdisciplinary Rehabilitation and Evaluation Programme for Patients With Chronic Widespread Pain: Randomized Controlled Trial, the IMPROvE Study
• Date of first enrolment: May 2011
• Target sample size: 192
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01352052
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Kirstine Amris, MD
• Affiliation: The Parker Institute, Frederiksberg University Hospital

• Name: Bente Danneskiold-Samsøe, Professor
• Affiliation: The Parker Institute, Frederiksberg University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Fibromyalgia

Chronic Widespread Pain

Intervention(s)

Other: interdisciplinary rehabilitation

Primary Outcome(s)

Assessment of Motor and Process Skills (AMPS) [Time Frame: change from baseline at the end of intervention and 6 months follow-up]

SF-36 Mental Composite Score [Time Frame: change from baseline at the end of intervention and 6 months follow-up]

Secondary Outcome(s)

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]

Depression; Major Depression Inventory (MDI) [Time Frame: change from baseline at the end of intervention and 6 months follow-up]

Pain catastrophizing; Coping Strategy Questionnaire (CSQ) [Time Frame: change from baseline at the end of intervention and at 6 months follow-up]

Pain self-efficacy; Pain Self-Efficacy Questionnaire [Time Frame: change from baseline at the end of treatment and at 6 months follow-up]

Anxiety; Generalised Anxiety Disorder (GAD-10) [Time Frame: change from baseline at the end of intervention and 6 months follow-up]

Cognitive functioning; ISPOCD 2 test battery [Time Frame: change from baseline at the end of intervention and 6 months follow-up]

Disease severity scales;Fibromyalgia Impact Questionnaire (FIQ) [Time Frame: change from baseline at the end of intervention and 6 months follow-up]

Activity intolerance; The Measure of Functional Ability (Tiredness) [Time Frame: change from baseline at the end of intervention and 6 months follow-up]

Secondary ID(s)

BDS-2011-099

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oak Foundation