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Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)

Primary Purpose

Complex Regional Pain Syndrome Type I

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Graded exposure in vivo
Physiotherapy
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome Type I focused on measuring Complex regional pain syndrome type I, Graded exposure in vivo, Physiotherapy, Pain-related fear

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis CRPS-I according to IASP criteria.
  2. Pain related (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32)
  3. Age between 18 and 65.
  4. Rehabilitation treatment has been indicated.

Exclusion Criteria:

  1. Pregnancy.
  2. Insufficient fluency in Dutch.
  3. Generalized pain syndrome.
  4. Dystonia.
  5. Sympathectomy of the affected extremity.
  6. Psychopathology
  7. Involvement in a claim regarding the disease.
  8. Substance abuse.
  9. Symptoms on both upper or both lower extremities.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Functional disability measured with: Radboud Skills Questionnaire (RASQ; Oerlemans, Cup et al., 2000), for upper limbs; Walking Ability Questionnaire (WAQ; Perez et al., 2002), for lower limbs

    Secondary Outcome Measures

    Physical activity in daily life
    Body function and structure
    Fear of movement
    Fear of pain
    Catastrophizing Scale
    Coping with pain
    Emotional distress
    Participation
    Emotional involvement

    Full Information

    First Posted
    February 21, 2008
    Last Updated
    September 18, 2014
    Sponsor
    Maastricht University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00625976
    Brief Title
    Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
    Official Title
    The Effectivity of Graded Exposure in Vivo Versus Standardized Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I) Patients With Pain Related Fear: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement at the level of pain and coping with pain. Only little improvement in functional restoration was found. Research in other pain populations such al neck- and back-pain patients has shown that pain related fear contributes to the development of functional disability. GEXP in vivo which aims on systematically reducing fear of movement, shows promising results in CRPS-I patients (de Jong et al., 2005). Objective: The objective of the proposed project is to compare the effectivity of GEXP in vivo with that of standardized physiotherapy in CRPS-I patients with pain related fear. Design: The study concerns a single blinded, single center, randomized clinical trial. The treatment will be preceded by two pre-measures. After treatment there will be one post-measurement and 3, 6 and 12 month follow-up measurements. Population: The study population will consist of chronic CRPS-I patients between 18 and 65, with pain related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32). Intervention: The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complex Regional Pain Syndrome Type I
    Keywords
    Complex regional pain syndrome type I, Graded exposure in vivo, Physiotherapy, Pain-related fear

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Graded exposure in vivo
    Intervention Description
    Graded exposure in vivo according to the protocol of de Jong et al. (2005)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physiotherapy
    Intervention Description
    Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)
    Primary Outcome Measure Information:
    Title
    Functional disability measured with: Radboud Skills Questionnaire (RASQ; Oerlemans, Cup et al., 2000), for upper limbs; Walking Ability Questionnaire (WAQ; Perez et al., 2002), for lower limbs
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Secondary Outcome Measure Information:
    Title
    Physical activity in daily life
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Body function and structure
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Fear of movement
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Fear of pain
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Catastrophizing Scale
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Coping with pain
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Emotional distress
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Participation
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
    Title
    Emotional involvement
    Time Frame
    2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis CRPS-I according to IASP criteria. Pain related (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32) Age between 18 and 65. Rehabilitation treatment has been indicated. Exclusion Criteria: Pregnancy. Insufficient fluency in Dutch. Generalized pain syndrome. Dystonia. Sympathectomy of the affected extremity. Psychopathology Involvement in a claim regarding the disease. Substance abuse. Symptoms on both upper or both lower extremities.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marielle Goossens, Dr.
    Organizational Affiliation
    Maastricht University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)

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