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Clinical Trials/NCT02582216
NCT02582216CompletedPhase 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 enrollmentStarted: March 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
22
Primary Endpoint
Pain on the Visual Analog Scale (VAS)

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

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