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ISRCTN
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ISRCTN68438240
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ClinicalTrials.gov identifier
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Public title
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Mirror therapy in patients with complex regional pain syndrome type one of the upper extremity: a randomised clinical trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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 Complex Regional Pain Syndrome (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 randomised clinical trial, mirror therapy will be presented in three phases:
1. One week Recognition of Hand Laterality using pictures of left and right hands
2. One week of Imagined Hand Movements, and
3. Four weeks of mirror therapy
Hypothesis:
Mirror therapy in patients with Complex Regional Pain Syndrome type one (CRPS I) has a positive effect on pain, oedema, sensibility, hand function, Activities of Daily Living (ADL) and quality of life compared to standard treatment.
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised, active controlled, parallel group, single blinded trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Complex regional pain syndrome type 1 (CRPS I)
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Participants - inclusion criteria
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Modified research diagnostic criteria for CRPS-1 based on Bruehl 1999.
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Participants - exclusion criteria
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1. Treatment for CRPS-I in another institution
2. Psychiatric problems
3. Lack of motivation
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Anticipated start date
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01/12/2005
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Anticipated end date
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01/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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52
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Interventions
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Mirror therapy versus standard treatment:
1. One week recognition of hand laterality using pictures of left and right hands
2. One week of imagined hand movements, and
3. Four weeks of mirror therapy
The control group will receive treatment following standard treatment guidelines.
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Primary outcome measure(s)
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Pain
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Secondary outcome measure(s)
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1. Hand function
2. ADL
3. Oedema
4. Sensibility
5. Quality of life
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Sources of funding
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1. Erasmus Medical Centre (The Netherlands)
2. Medical Research Advisory Committee Erasmus (MRACE) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
Ton A R
Schreuders
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Address
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Erasmus Medical Centre
Department of Rehabilitation Medicine, Room H014
P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Tel
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+31 (0)10 463 2867
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Fax
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+31 (0)10 463 3843
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Email
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a.schreuders@erasmusmc.nl
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Sponsor
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Erasmus Medical Centre (The Netherlands)
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Address
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P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Sponsor website:
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http://www.erasmusmc.nl/
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Date applied
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23/02/2007
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Last edited
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23/02/2007
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Date ISRCTN assigned
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23/02/2007
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