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3D Augmented Reality Mirror Visual Feedback Applied to the Treatment of Unilateral Upper Extremity Neuropathic Pain.

Phase 1
Completed
Conditions
Neuralgia
Interventions
Device: 3D augmented reality
Registration Number
NCT02582216
Lead Sponsor
Erasme University Hospital
Brief Summary

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.

Detailed Description

Each patient receives 5 treatment periods over a total period of 1 week, where each treatment period lasts a total of 20 minutes.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Open label3D augmented reality3D augmented reality
Primary Outcome Measures
NameTimeMethod
Pain on the Visual Analog Scale (VAS)baseline and week

Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain)

Secondary Outcome Measures
NameTimeMethod
Neuropathic Pain Assessed With DN4 Questionnaire1 week

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

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