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

NCT ID: NCT02667717

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2019-06-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Reflex Sympathetic Dystrophy Causalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mirror therapy

Intervention Type BEHAVIORAL

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.

Usual care

Intervention Type BEHAVIORAL

Patients will have the usual care as an intervention.

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Patients will have the usual care as an intervention.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

Patients will have the usual care as an intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CREAC'H Christelle, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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MPR des Massues

Lyon, , France

Site Status

Centre médical de l'Argentière

Saint-Etienne, , France

Site Status

Chu Saint Etienne

Saint-Etienne, , France

Site Status

Consultation Douleur de la Mutualité de la Loire

Saint-Etienne, , France

Site Status

MPR de l'Hôpital Drôme Nord

Saint-Vallier, , France

Site Status

Countries

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France

Other Identifiers

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2016-A00088-43

Identifier Type: OTHER

Identifier Source: secondary_id

1508193

Identifier Type: -

Identifier Source: org_study_id

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