|- candidate number||1496|
|- NTR Number||NTR298|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Treatment of Complex Regional Pain Syndrome Type I with Mirror Therapy.|
|- Scientific Title||Treatment of Patients with Complex Regional Pain Syndrome Type I with Mirror Therapy to Improve the Arm-Hand Function.|
|- ACRONYM||Treatment of Complex Regional Pain Syndrome Type I with Mirror Therapy|
|- hypothesis||The hypothesis of this study is that mirror therapy stimulates cortical representation of the upper extremity. The functionality of the upper extremity will improve more than with only conservative therapy.|
|- Healt Condition(s) or Problem(s) studied||Complex regional pain syndrome type 1 (CRPS I)|
|- Inclusion criteria||1. Patients with CRPS I of one upper extremity.(following IASP-criteria);|
2. It exists for less than 8 months;
3. Patient is over 18 years of age.
|- Exclusion criteria||1. Dysfunction of the other upper extremity;|
3. Little motivation;
4. Treatment for CRPS-I in an other institution simultaneous;
5. Psychiatric problems.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2005|
|- planned closingdate||1-apr-2007|
|- Target number of participants||20|
|- Interventions||Mirror therapy.|
|- Primary outcome||Activity: Action Research Arm test.|
|- Secondary outcome||1. Function of the upper extremity: pain (VAS), mobility (Range of Motion),grip strenght (Jamar), sensibility (monofilaments);|
2. Activity: Radbout Skills Questionair.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Sandra R. Manen, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.H. Groot, de|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Rehabilitation Medicine|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC), Department of Rehabilitation Medicine|
|- Brief summary||CRPS-I is characterized by pain, oedema and sympathic dysfunction and is generally preceded by trauma. |
The cause is however not known. We hypothesise that a central factor in the movement planning may play a role, which expresses as 'fear to move'.
In order to intervene, mirror therapy is applied in combination with the regular therapy.
Mirror therapy is based on the principle that reflection of the healthy arm causes the illusion that the injured arm moves simultaneous and symmetrical with the healthy arm and thus stimulates the cortical representation of the injured arm.
In a randomised study of 20 acute CRPS-1 patients (based on the IASP-criteria), all patients receive regular physiotherapy and 10 subjects receive additional mirror therapy.
Primary outcome is arm function, quantified by the Action Research Arm Test (ARA). Secondary outcome parameters are pain (VAS), mobility (Range of Motion), grip strength (JAMAR), sensibility (monofilaments) and the Radbout Skills Questionair.
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 16-nov-2009|