Contact information
Type
Scientific
Primary contact
Dr Ton A R Schreuders
ORCID ID
Contact details
Erasmus Medical Centre
Department of Rehabilitation Medicine
Room H014
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 2867
a.schreuders@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Complex regional pain syndrome type 1 (CRPS I)
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pain
Secondary outcome measures
1. Hand function
2. ADL
3. Oedema
4. Sensibility
5. Quality of life
Overall trial start date
01/12/2005
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Modified research diagnostic criteria for CRPS-1 based on Bruehl 1999.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
52
Participant exclusion criteria
1. Treatment for CRPS-I in another institution
2. Psychiatric problems
3. Lack of motivation
Recruitment start date
01/12/2005
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Research Advisory Committee Erasmus (MRACE) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary