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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy |
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| Group 2 | Experimental | 3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy |
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| Group 3 | Experimental | 2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional therapy | Other | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud DUPEYRON | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes | Nîmes | 30129 | France |
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| ARMT | Other | 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. |
|
| cortical reactivity | Other | 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). |
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| Fluidity of movement | Other | 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). |
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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) |
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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