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
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
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.
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
NCT ID
NCT00625976
First Posted
February 21, 2008
Last Updated
September 18, 2014
Sponsor
Maastricht University Medical Center
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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