Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy (AlgoMIR)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Causalgia; Reflex Sympathetic Dystrophy

Treatments: Behavioral: Mirror therapy; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02667717

2016-A00088-43 (Other Identifier)

1508193

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Experimental group : Mirror Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Mirror therapy

Behavioral: Usual care

Control group : Usual care

Active Comparator group

Description:

The control group will benefit from the usual care during 16 weeks. No mirror therapies will be performed to this group.

Treatment:

Behavioral: Usual care