Reflex Sympathetic DystrophyAlgoMIRNCT02667717
Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy
A study testing Mirror therapy in people with Reflex Sympathetic Dystrophy and Causalgia, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reflex Sympathetic Dystrophy, Causalgia
- What is being tested?
- Mirror therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesFrance
- Study dates
- 6 Jun 2017to 6 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
MPR des Massues
Lyon, 69000
Centre médical de l'Argentière
Saint-Etienne, 42100
Chu Saint Etienne
Saint-Etienne, 42100
Consultation Douleur de la Mutualité de la Loire
Saint-Etienne
MPR de l'Hôpital Drôme Nord
Saint-Vallier
About this study
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.
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.
Read the 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.
- Conditions
- Reflex Sympathetic Dystrophy, Causalgia
- Being tested
- Mirror therapy, Usual care
- Medical subject headings
- Reflex Sympathetic Dystrophy, Causalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyBehavioural
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.
Usual careBehavioural
Patients will have the usual care as an intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mirror therapy; Behavioral: 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start6 Jun 2017
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Why it stopped: difficulties in including patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflex Sympathetic DystrophyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CREAC'H Christelle, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667717
- Sponsor's protocol ID
- 1508193
- Other IDs
- 2016-A00088-43
- Acronym
- AlgoMIR
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02667717
- Acronym / sponsor ID
- AlgoMIR / 1508193
- Conditions
- Reflex Sympathetic Dystrophy, Causalgia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in including patients
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group : Mirror Therapy | Experimental | Behavioral: Mirror therapy, Behavioral: Usual careExperimental 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. |
| Control group : Usual care | Active comparator | Behavioral: Usual careThe control group will benefit from the usual care during 16 weeks. No mirror therapies will be performed to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 )
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror therapyThe 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. | Behavioural | Experimental group : Mirror Therapy |
| Usual carePatients will have the usual care as an intervention. | Behavioural | Control group : Usual care, Experimental group : Mirror Therapy |
Primary outcome
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
Results and safety
The study was stopped early (reason given: difficulties in including patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CREAC'H Christelle, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror therapy in people with Reflex Sympathetic Dystrophy and Causalgia, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties in including patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the Visual Analogue Scale (EVA) of pain (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.