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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 21, 2008 | ||||||||
| Last Updated Date | April 21, 2008 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00625976 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I) | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Complex Regional Pain Syndrome Type I | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 110 | ||||||||
| Estimated Completion Date | September 2011 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00625976 | ||||||||
| Responsible Party | Dr. M. Goossens, Maastricht University | ||||||||
| Study ID Numbers ICMJE | MEC 08-3-004, NL20067.068.08 | ||||||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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