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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Reflex Sympathetic Dystrophy; Causalgia
• Intervention / Treatment: Behavioral: Mirror therapy; Behavioral: Usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69000
    • MPR des Massues
  • Saint Etienne, France
    • Consultation Douleur de la Mutualité de la Loire
  • Saint Vallier, France
    • MPR de l'Hôpital Drôme Nord
  • St Etienne, France, 42100
    • Centre Médical de L'argentière
  • St Etienne, France, 42100
    • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.	Behavioral: Usual care; Patients will have the usual care as an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the Visual Analogue Scale (EVA) of pain	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	Week 8

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: CREAC'H Christelle, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Causalgia
• Other Study ID Numbers: 1508193; 2016-A00088-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No