NCT01352052

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

May 4, 2011

Last Update Submit

August 9, 2016

Conditions

Chronic Widespread PainFibromyalgia

Keywords

chronic widespread painfibromyalgiaoutcome assessmentfunctional abilityAMPSrehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

waiting list assignment

NO INTERVENTION

6 months waiting list assignment followed by the 2-week interdisciplinary rehabilitation programme

Intervention: interdisciplinary rehabilitation programme

ACTIVE COMPARATOR

A two-weeks non-residential, group-based, psycho-educative treatment course conducted by an interdisciplinary team.

Other: interdisciplinary rehabilitation

Interventions

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.

Intervention: interdisciplinary rehabilitation programme

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Parker Institute, Frederiksberg Hospital

Frederiksberg, Frederiksberg, 2000, Denmark

Location

The Parker Institute, Frederiksberg University Hospital

Frederiksberg, 2000, Denmark

Location

Related 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):664-669. doi: 10.1016/j.pain.2010.08.023. Epub 2010 Sep 15.

    PMID: 20832941BACKGROUND

  • 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.

    PMID: 20598803BACKGROUND

  • 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.

    PMID: 17257757BACKGROUND

Related Links

MeSH Terms

Conditions

Chronic PainFibromyalgia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Bente Danneskiold-Samsøe, Professor

    The Parker Institute, Frederiksberg University Hospital

    STUDY DIRECTOR

  • Kirstine Amris, MD

    The Parker Institute, Frederiksberg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 11, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

DK(2)