NCT02667717

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 26, 2016

Last Update Submit

January 15, 2021

Conditions

Reflex Sympathetic DystrophyCausalgia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental group : Mirror Therapy

EXPERIMENTAL

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 therapyBehavioral: Usual care

Control group : Usual care

ACTIVE COMPARATOR

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

Behavioral: Usual care

Interventions

Mirror therapyBEHAVIORAL

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.

Experimental group : Mirror Therapy
Usual careBEHAVIORAL

Patients will have the usual care as an intervention.

Control group : Usual careExperimental group : Mirror Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

MPR des Massues

Lyon, 69000, France

Location

Centre médical de l'Argentière

Saint-Etienne, 42100, France

Location

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

Consultation Douleur de la Mutualité de la Loire

Saint-Etienne, France

Location

MPR de l'Hôpital Drôme Nord

Saint-Vallier, France

Location

MeSH Terms

Conditions

Reflex Sympathetic DystrophyCausalgia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Complex Regional Pain SyndromesAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeuralgia

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • CREAC'H Christelle, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

June 6, 2017

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)