Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy (AlgoMIR)
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ClinicalTrials.gov Identifier: NCT02667717 |
Recruitment Status :
Terminated
(difficulties in including patients)
First Posted : January 29, 2016
Last Update Posted : January 20, 2021
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AlgoMIR project born thanks to a meeting between pain professionals and re-education staff. The goal of this project is to develop and evaluate a program of learning with exercises by mirror therapy, that could be easily shared with paramedic teams and easily adapted to different handicaps.
Researchers have chosen to select patients with re-education of the upper extremity to benefit from rehabilitation sessions either from physiotherapists present in their city, or of functional rehabilitation hospital units.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Reflex Sympathetic Dystrophy Causalgia | Behavioral: Mirror therapy Behavioral: Usual care | Not Applicable |
The Complex Regional Painful Syndromes (CRPS) called in the past aglodystrophia, are characterized by the apparition of pain abnormally spread and intensive compared to the initial causal factor. They are usually associated to negligence of the painful limb, and avoidance movements that require care in rehabilitation that it is carried out in the physiotherapist center or functional rehabilitation unit at hospital.
Recently, mirror therapy has been proposed to correct dysfunctions : patients have to realize a movement with their two hands, observing the reflect of their healthy hand in a mirror, while their painful hand is hidden behind the mirror. After a learning phase, patients have to continue this kind of therapy independently.
AlgoMIR project born thanks to a meeting between pain professionals and re-education staff. The goal of this project is to develop and evaluate a program of learning with exercises by mirror therapy, that could be easily shared with paramedic teams and easily adapted to different handicaps.
Researchers have chosen to select patients with re-education of the upper extremity to benefit from rehabilitation sessions either from physiotherapists present in their city, or of functional rehabilitation hospital units.
The primary outcome of this project is to compare analgesic effect at 8 and 16 weeks of a therapy mirror re-education program associated to a usual care (M+R), and of a usual care program (R).
A second goal is to understand eventual difficulties met by the patients and improve efficacy of the autonomous becoming of patients using mirror therapy.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy in the Complex Regional Pain Syndrome of the Upper Limb : a Multicentric Randomized Open Study. |
Actual Study Start Date : | June 6, 2017 |
Actual Primary Completion Date : | June 6, 2019 |
Actual Study Completion Date : | June 6, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental group : Mirror Therapy
Experimental group will perform mirror therapies during 16 weeks, added to the usual care. Therapy mirror sessions will take place at hospital units but also at home.
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Behavioral: Mirror therapy
The intervention is a mirror therapy. The mirror therapy consists in performing some movements with a mirror, the hand that is painful is hidden and the image of the healthy hand is reflected in the mirror. Patients looking at this image seems to see their painful hand moving. Behavioral: Usual care Patients will have the usual care as an intervention. |
Active Comparator: Control group : Usual care
The control group will benefit from the usual care during 16 weeks. No mirror therapies will be performed to this group.
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Behavioral: Usual care
Patients will have the usual care as an intervention. |
- Compare the Visual Analogue Scale (EVA) of pain [ Time Frame: Week 8 ]
Compare after 8 weeks the score of EVA of pain in the last 24 hours for patients who performed during 8 weeks :
- a program of mirror therapy associated with the usual care (M+R) or
- the usual care without mirror therapy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Affiliation to Social Security
- CRPS (complex regional pain syndrome) type I or II defined by the criteria of Bruehl (Table 1)
- CRPS of the upper limb including the wrist and / or hand
- CRPS post-surgical or post-traumatic
- Average pain in the last 24 hours of intensity > = 30/100 on EVA (0 no pain, 100: worst pain imaginable )
- Evolution for over 3 months and less than 2 years
- Patients taking a stable background therapy for 15 days and not having received the following treatments in the previous months : bisphosphonate cure, infiltration, Qutenza, ketamine infusions
- Patients accepting a rehabilitation (physiotherapists or hospital units for patients included on Saint-Etienne and hospital units for patients included in Lyon and Saint- Vallier)
Exclusion Criteria:
- CRPS post stroke or drug
- Adhesive capsulitis isolated
- Cognitive or language difficulties preventing understanding instructions and / or a correct clinical evaluation
- Patient who already received a rehabilitation program with the use of mirror therapy or other virtual reality technology
- CRPS in connection with an accident caused by a third party for which a legal procedure is underway
- Major Depressive Episode
- Dissociative Disorders
- Visually impaired patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667717
France | |
MPR des Massues | |
Lyon, France, 69000 | |
Consultation Douleur de la Mutualité de la Loire | |
Saint Etienne, France | |
MPR de l'Hôpital Drôme Nord | |
Saint Vallier, France | |
Centre médical de l'Argentière | |
St Etienne, France, 42100 | |
Chu Saint Etienne | |
St Etienne, France, 42100 |
Principal Investigator: | CREAC'H Christelle, MD | CHU SAINT ETIENNE |
Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT02667717 |
Other Study ID Numbers: |
1508193 2016-A00088-43 ( Other Identifier: ANSM ) |
First Posted: | January 29, 2016 Key Record Dates |
Last Update Posted: | January 20, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Reflex Sympathetic Dystrophy Complex Regional Pain Syndromes Causalgia Autonomic Nervous System Diseases |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neuralgia |