Ignite Creation Date:
2024-05-05 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00625976
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2008-02-21
Brief Title:
Graded Exposure GEXP in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I CRPS-I
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL2006706808 | None | None | None |