Neuralgia Clinical Trial
Official title:
3D Augmented Reality Mirror Visual Feedback Therapy Applied to the Treatment of Persistent, Unilateral Upper Extremity Neuropathic Pain: A Preliminary Study
Verified date | August 2020 |
Source | Erasme University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Neuropathic pain in the unilateral upper extremity scored by DN4 questionnaire - At least 3 months symptom duration following injury - Minimum pain of 40 on a visual analogue scale (VAS); - A drug treatment regimen that was stable for at least 2 weeks. - Subjects were allowed to participate if they presented with any of the following: (1) A CRPS diagnosis, in accordance with the International Association for the Study of Pain criteria, Phantom Limb Pain (PLP), or spinal cord injury or plexopathy; and (2) an history of being treated before by conventional mirror therapy but, in their case, the mirror therapy failed. Exclusion Criteria: - Bilateral injury, - Patients with epilepsy - Side effects known to 3D (such as nausea, cephalalgia) - Cognitive disorder - Poor knowledge of the French language. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Erasme University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 |
1 week | |
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) | baseline and week | |
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: The practitioner questions the patient himself and completes the questionnaire For each item, he must provide a "yes" or "no" answer At the end of the questionnaire, the practitioner counts the responses, 1 for each "Yes" and 0 for each "no". The sum obtained gives the Patient Score, noted out of 10. 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 |
1 week |
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