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

Primary Purpose

Reflex Sympathetic Dystrophy, Causalgia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mirror therapy
Usual care
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Reflex Sympathetic Dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • MPR des Massues
  • Consultation Douleur de la Mutualité de la Loire
  • MPR de l'Hôpital Drôme Nord
  • Centre médical de l'Argentière
  • Chu Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group : Mirror Therapy

Control group : Usual care

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 26, 2016
Last Updated
January 15, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02667717
Brief Title
Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy
Acronym
AlgoMIR
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
difficulties in including patients
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflex Sympathetic Dystrophy, Causalgia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group : Mirror Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Control group : Usual care
Arm Type
Active Comparator
Arm Description
The control group will benefit from the usual care during 16 weeks. No mirror therapies will be performed to this group.
Intervention Type
Behavioral
Intervention Name(s)
Mirror therapy
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Patients will have the usual care as an intervention.
Primary Outcome Measure Information:
Title
Compare the Visual Analogue Scale (EVA) of pain
Description
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
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CREAC'H Christelle, MD
Organizational Affiliation
CHU SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
MPR des Massues
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Consultation Douleur de la Mutualité de la Loire
City
Saint Etienne
Country
France
Facility Name
MPR de l'Hôpital Drôme Nord
City
Saint Vallier
Country
France
Facility Name
Centre médical de l'Argentière
City
St Etienne
ZIP/Postal Code
42100
Country
France
Facility Name
Chu Saint Etienne
City
St Etienne
ZIP/Postal Code
42100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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