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This study has two objectives. First, to introduce a new virtual reality method that incorporates the mechanisms used in mirror visual feedback through a three-dimensional (3D) augmented virtual reality system. Second, to evaluate the efficiency of this new method on a convenience sample of patients presenting with unresolved neuropathic pain (CRPS, PLP, plexopathy, stroke) who were not responding adequately to both pharmaceutical management and traditional mirror therapy.
Each patient receives 5 treatment periods over a total period of 1 week, where each treatment period lasts a total of 20 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Experimental | 3D augmented reality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D augmented reality | Device | Each treatment period included a 3DARS (3D augmented reality system)training session.All 3DARS training sessions were performed in the same quiet room under the supervision of the same single investigator.The 3DARS training session protocol included two virtual training procedures. The first virtual training procedure consisted of applying a vertical virtual mirror to the display screen, where the non-affected side of the patient's body (such as the right) was symmetrically duplicated by a vertical axis on the affected side (such as the left).The second virtual training procedure consisted of flipping the 3D image horizontally along a vertical axis. This allowed patients to observe the reflection of their non-affected upper extremity as if it was the affected one. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on the Visual Analog Scale (VAS) | Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain) | baseline and week |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Pain Assessed With DN4 Questionnaire | DN4 (Douleur Neuropathique en 4 Questions) is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. When the practitioner suspects neuropathic pain, the DN4 questionnaire is useful as a diagnostic tool. This questionnaire is divided into 4 questions representing 10 check items:
If the patient's score is 4/10 or more, the test is positive (sensitivity at 82.9%; specificity at 89.9%) Dn4 questionnaire were completed before and 24 hour after the last session |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire de Saint-Antoine | French adaptation of Melzack's MC Gill Pain Questionnaire (MPQ). It is a questionnaire of 61 qualifying words divided into 17 subclasses: 9 sensory, 7 emotional, 1 evaluative. The patient is asked to select the adjectives and then rate them from 0 (not at all) to 4 (extremely). This self-assessment scale allows clinical practice to specify the participation of the sensory and the emotional in pain intensity. self-questionnaire scoring the sensory and emotional qualities of the pain |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label | 3D augmented reality |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | 3D augmented reality |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain on the Visual Analog Scale (VAS) | Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain) | Posted | Mean | Standard Deviation | units on a scale | baseline and week |
|
|
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Virtual training activities were terminated if patients complained about the development of headache or nausea, which are the most common side effects provoked by the use of stereovision systems similar to the 3DARS system. These symptoms were not present in this population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label | patients received a 3D augmented reality treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dominique Mouraux | Hôpital Erasme | +32/2.555.38.48 | dmouraux@ulb.ac.be |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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|
| 1 week |
| 1 week |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Neuropathic Pain Assessed With DN4 Questionnaire | DN4 (Douleur Neuropathique en 4 Questions) is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. When the practitioner suspects neuropathic pain, the DN4 questionnaire is useful as a diagnostic tool. This questionnaire is divided into 4 questions representing 10 check items:
If the patient's score is 4/10 or more, the test is positive (sensitivity at 82.9%; specificity at 89.9%) Dn4 questionnaire were completed before and 24 hour after the last session | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Other Pre-specified | Questionnaire de Saint-Antoine | French adaptation of Melzack's MC Gill Pain Questionnaire (MPQ). It is a questionnaire of 61 qualifying words divided into 17 subclasses: 9 sensory, 7 emotional, 1 evaluative. The patient is asked to select the adjectives and then rate them from 0 (not at all) to 4 (extremely). This self-assessment scale allows clinical practice to specify the participation of the sensory and the emotional in pain intensity. self-questionnaire scoring the sensory and emotional qualities of the pain | Not Posted | 1 week | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |