|- candidate number||1860|
|- NTR Number||NTR530|
|- ISRCTN||ISRCTN68438240 |
|- Date ISRCTN created||23-feb-2007|
|- date ISRCTN requested||13-jan-2006|
|- Date Registered NTR||28-nov-2005|
|- Secondary IDs||N/A |
|- Public Title||Mirror therapy in patients with CRPS I of the upper extremity; a randomized clinical trial.|
|- Scientific Title||Mirror therapy in patients with CRPS I of the upper extremity; a randomized clinical trial.|
|- ACRONYM||Mirror therapy in CRPS I|
|- hypothesis||Mirror therapy in patients with CRPS I has a positive effect on pain, oedema, sensibility, hand function, ADL and quality of life compared to standard treatment.|
|- Healt Condition(s) or Problem(s) studied||Complex regional pain syndrome type 1 (CRPS I)|
|- Inclusion criteria||Modified research diagnostic criteria for CRPS-1 based on Bruehl 1999.|
|- Exclusion criteria||1. Treatment for CRPS-I in an other institution; |
2. Psychiatric problems;
3. Lack of motivation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2005|
|- planned closingdate||1-dec-2007|
|- Target number of participants||52|
|- Interventions||Mirror therapy versus standard treatment.|
|- Primary outcome||Pain.|
|- Secondary outcome||1. Hand function
5. Quality of life.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. Ton A.R. Schreuders|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Ruud W. Selles|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Mrace Comittee, Erasmus MC|
|- Brief summary||Mirror therapy was introduced by Ramachandran in patient with phantom limb pain and is based on new knowledge about the plasticity of the brain. Recently, studies in patients with CRPS have suggested that exercising with the painful hand behind a mirror and watching a reflection of the normal hand will give the brain the illusion that the hand is now able to move normally. |
In these controlled but undersized studies, positive effects were reported on pain, oedema and hand function.
In the present single-blind randomized clinical trial, mirror therapy will be presented in three phases:
1. one week Recognition of Hand Laterality using pictures of left and right hand;
2. one week of Imagined Hand Movements;
3. four weeks of mirror therapy.
The control group will receive treatment following standard treatment guidelines.
The primary outcome of this study is pain, and secondary outcomes are hand function, ADL, oedema, sensibility, and quality of life.
|- Main changes (audit trail)|
|- RECORD||28-nov-2005 - 18-jan-2010|