Clinical trial NCT02667717: Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy
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
Overall status: TERMINATED
Phase: NA
Conditions: Reflex Sympathetic Dystrophy
Causalgia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Compare the Visual Analogue Scale (EVA) of pain
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: MPR des Massues
city: Saint Etienne
country: France
facility: Consultation Douleur de la Mutualité de la Loire
city: Saint Vallier
country: France
facility: MPR de l'Hôpital Drôme Nord
city: St Etienne
country: France
facility: Centre médical de l'Argentière
city: St Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: CREAC'H Christelle, MD
role: PRINCIPAL_INVESTIGATOR
References: