Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity

Study Overview
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Brief Summary
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Complex Regional Pain Syndrome (CRPS) is a polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes. The diagnostic criteria of the disease follow the Budapest criteria, namely (i) vasomotor disorders (temperature asymmetry, color changes), (ii) sudomotor/oedema (sweating changes, edema), (iii) sensory (hyperesthesia, allodynia, hyperalgesia) and (iv) motor/trophic (reduced joint mobility, weakness, tremor, dystonia, trophic disorders of skin, nails, hair). Of the many treatments, augmented reality mirror therapy (ARMT), is novel in substituting a virtual environment for part of the real environment. This type of device has never been studied from a clinical point of view in the treatment of upper limb CRPS, whereas fMRI and clinical dissertation studies have suggested an improvement in neuroplasticity. The aim of this study is to establish the clinical effects of ARMT on CRPS, and to evaluate its benefit within a conventional rehabilitation treatment (physiotherapy and occupational therapy).

Official Title
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Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity: a Single Case Experimental Design (SCED) Study.

Conditions
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Complex Regional Pain Syndromes

Intervention / Treatment
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* Other: Conventional therapy
* Other: ARMT
* Other: cortical reactivity
* Other: Fluidity of movement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan Patient with CRPS of the upper limb according to the Budapest criteria. Patient newly treated at the Centre d'Evaluation et de Traitement de la Douleur of the CHU of Nîmes. Patient with a diagnosis of CRPS for more than 3 months Exclusion Criteria: The subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study The subject unable to express consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship Patient is pregnant, parturient or breastfeeding Patient with medically significant visual impairment that is incompatible with the practice of ARMT Patient with CRPS secondary to a stroke Patient with cognitive disorders (Montreal Cognitive Assessment scale less than 26) Patient with Unilateral Spatial Negligence according to the Bell's test Patient with arthrodesis of one of the joints of the upper limbs. Patient with an unhealed fracture of one of the upper limbs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy | Other: Conventional therapy<br>* The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.<br>Other: ARMT<br>* The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.<br>Other: cortical reactivity<br>* An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).<br>Other: Fluidity of movement<br>* Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).<br>|
| Experimental: Group 2<br>3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy | Other: Conventional therapy<br>* The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.<br>Other: ARMT<br>* The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.<br>Other: cortical reactivity<br>* An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).<br>Other: Fluidity of movement<br>* Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).<br>|
| Experimental: Group 3<br>2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy | Other: Conventional therapy<br>* The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.<br>Other: ARMT<br>* The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.<br>Other: cortical reactivity<br>* An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).<br>Other: Fluidity of movement<br>* Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in upper extremity motor function using ARMT versus CT alone | Change in Box and Block Test (BBT) score. The score will be compared between the right and left hand and against reference values according to age and sex. | Every Monday and Thursday until study end (10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in clinical signs of CRPS using ARMT versus CT alone | Change in Complex regional pain syndrome Severity Score (CSS); score out of 16 | Every Monday and Thursday until study end (10 weeks) | 
| Improvement in quality of life using ARMT versus CT alone | Change in EQ-5D-3L questionnaire score. The first part is a score out of 15 total (scoring out of 3 per item). The second part is a scale numbered 0 to 100 (0 being the worst health imaginable to 100 being the best health imaginable). | Every Monday and Thursday until study end (10 weeks) | 
| Improvement in global impression of change using ARMT versus CT alone | Change in Patient Global Impression of Change (PGIC) Questionnaire score. The measurement is between 1 and 7. It is a qualitative scale converted into a numerical scale. | Every Monday and Thursday until study end (10 weeks) | 
| Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone | Change in proprioceptive section of the Rivermead Assessment of Somatosensory Performance questionnaire score. 5 joints are tested 6 times. Thus for each joint, the score is out of 6, for a total score of 30. | Every Monday and Thursday until study end (10 weeks) | 
| Improvement of mental imagery ability using ARMT versus CT alone | Change in mental chronometry. Measured using a modified Box and Block Test to give a ratio = (real task time - imagined task time) / real task time | Every Monday and Thursday until study end (10 weeks) | 
| Improvement n perceived pain at movement and at rest using ARMT versus CT alone | Change in pain, reported on a 0-10 visual analog scale | Daily until study end (10 weeks) | 
| effectiveness of rehabilitation program adding TMRA device on cortical reactivity or Event related Potential (ERP) between pre- and post-treatment on pathological limb | Measurement of signal power amplitude (in microVolts) in motor imagery task and motor execution task compared with a resting task | Before Intervention (Day 0) and at the end of the study (10 weeks) | 
| evolution of cortical reactivity or event-related potential (ERP) between the healthy and pathological sides following a rehabilitation program adding a TMRA device. | Amplitude of signal power (in microVolts) in motor imagery task and motor execution task compared with a resting task | at the end of the study (10 weeks) | 
| effectiveness of a rehabilitation program adding a TMRA device on smoothness of movement on the pathological limb between pre- and post-treatment | Leap Motion Control motion capture device from Ultraleap Company (description) | Before Intervention (Day 0) and at the end of the study (10 weeks) | 
| To compare the smoothness of movement between the healthy and pathological side following a rehabilitation programme adding a TMRA device. | Amplitude of signal power in motor imagery task and motor execution task compared with a resting task (descriptive, adimentional) | at the end of the study (10 weeks) | 
| Correlate the power of cortical reactivity with fluidity of movement, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity. | Correlation between 2 signals: cortical and motor for motor execution tasks (adimentional) | Before Intervention (Day 0) and at the end of the study (10 weeks) | 
| Correlate fluidity of movement with the power of cortical reactivity, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity. | Multiple correlation (adimentional) | Before Intervention (Day 0) and at the end of the study (10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirror Movement Therapy, Physical Therapy Modalities