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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 : Recruiting
First Posted : January 29, 2016
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Reflex Sympathetic Dystrophy Causalgia Behavioral: Mirror therapy Behavioral: Usual care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020


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.




Primary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


Contacts
Contact: CREAC'H Christelle, MD 0477828391 ext 33 christelle.creach@univ-st-etienne.fr
Contact: DEYGAS Béatrice, CRA beatrice.deygas@chu-st-etienne.fr

Locations
France
MPR des Massues Not yet recruiting
Lyon, France, 69000
Contact: BERGER Mathilde, OT    04 72 38 48 58    direction@cmcr-massues.com   
Principal Investigator: BERGER Mathilde, OT         
Consultation Douleur de la Mutualité de la Loire Not yet recruiting
Saint Etienne, France
Contact: LUMINET Delphine, IDE         
Principal Investigator: LUMINET Delphine, IDE         
MPR de l'Hôpital Drôme Nord Not yet recruiting
Saint Vallier, France
Contact: COSTE Sophie, OT         
Principal Investigator: COSTE Sophie, OT         
Sub-Investigator: CLEMENT Mélissa, IDE         
Sub-Investigator: BATIN Alexandra, IDE         
Sub-Investigator: SORET Pascale, IDE         
Centre médical de l'Argentière Not yet recruiting
St Etienne, France, 42100
Contact: BEYNEL Anne-Claire, OT    04.74.26.41.41    cma@ch-argentiere.fr   
Principal Investigator: BEYNEL Anne-Claire, OT         
Sub-Investigator: REDISSI Aïcha, OT         
Chu Saint Etienne Recruiting
St Etienne, France, 42100
Contact: CREAC'H Christelle, MD    04 77 42 14 26    christelle.creach@univ-st-etienne.fr   
Principal Investigator: CREAC'H Christelle, MD         
Sub-Investigator: GRAND Stéphanie, OT         
Sub-Investigator: QUESADA Charles, PT         
Sub-Investigator: MANISSOL Brigitte, IDE         
Sub-Investigator: MIALLON Chantal, IDE         
Sub-Investigator: PANDRAUX Brigitte, IDE         
Sub-Investigator: PEPIN Arlette, M         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: CREAC'H Christelle, MD CHU SAINT ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02667717     History of Changes
Other Study ID Numbers: 1508193
2016-A00088-43 ( Other Identifier: ANSM )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
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

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Causalgia
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuralgia