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Clinical Trials/NCT02582216
NCT02582216
Completed
Phase 1

3D Augmented Reality Mirror Visual Feedback Therapy Applied to the Treatment of Persistent, Unilateral Upper Extremity Neuropathic Pain: A Preliminary Study

Erasme University Hospital0 sites22 target enrollmentMarch 2013
ConditionsNeuralgia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Neuralgia
Sponsor
Erasme University Hospital
Enrollment
22
Primary Endpoint
Pain on the Visual Analog Scale (VAS)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
December 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Erasme University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pain on the Visual Analog Scale (VAS)

Time Frame: 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 Outcomes

  • Neuropathic Pain Assessed With DN4 Questionnaire(1 week)

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