AzTrials
AzTrials

Chronic Widespread PainIMPROvENCT01352052

Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain

A study testing interdisciplinary rehabilitation in people with Chronic Widespread Pain and Fibromyalgia, run by Frederiksberg University Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Chronic Widespread Pain, Fibromyalgia
What is being tested?
interdisciplinary rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
2 sitesDenmark
Study dates
May 2011to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • The Parker Institute, Frederiksberg Hospital

    Frederiksberg, Frederiksberg, 2000

  • The Parker Institute, Frederiksberg University Hospital

    Frederiksberg, 2000

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
interdisciplinary rehabilitation
Keywords
chronic widespread pain, fibromyalgia, outcome assessment, functional ability, AMPS, rehabilitation
Medical subject headings
Chronic Pain, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interdisciplinary rehabilitationOther

    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.

Study groups in NCT01352052
Study groupRoleWhat they receive
waiting list assignmentNo intervention6 months waiting list assignment followed by the 2-week interdisciplinary rehabilitation programme
Intervention: interdisciplinary rehabilitation programmeActive comparatorA two-weeks non-residential, group-based, psycho-educative treatment course conducted by an interdisciplinary team.
Receives: Other: interdisciplinary rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. SF-36 Mental Composite Score

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

Secondary outcomes (8)

  1. Health related quality of life scales; Short-Form-36 Health Survey (SF-36)

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

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

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

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

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

  4. Depression; Major Depression Inventory (MDI)

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

  5. Pain catastrophizing; Coping Strategy Questionnaire (CSQ)

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

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

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

  7. Cognitive functioning; ISPOCD 2 test battery

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01352052
Sponsor's protocol ID
BDS-2011-099
Acronym
IMPROvE
Status last verified
Aug 2016
First submitted
4 May 2011
Last updated
10 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20832941

  • 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.

    PubMed 20598803

  • 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.

    PubMed 17257757

Questions about this trial

What is this clinical trial studying?

A study testing interdisciplinary rehabilitation in people with Chronic Widespread Pain and Fibromyalgia, run by Frederiksberg University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Motor and Process Skills (AMPS) (time frame: change from baseline at the end of intervention and 6 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01352052, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in