Condition category
Musculoskeletal Diseases
Date applied
23/02/2007
Date assigned
23/02/2007
Last edited
08/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/

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

Publication citations

Additional files

Editorial Notes