Complex Regional Pain Syndrome Type I Clinical Trial
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
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | September 2014 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Physical activity in daily life | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Body function and structure | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Fear of movement | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Fear of pain | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Catastrophizing Scale | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Coping with pain | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Emotional distress | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Participation | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No | |
Secondary | Emotional involvement | 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up | No |
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