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Phase 2 N=22 Treatment

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

Neuralgia

Bottom Line

View on ClinicalTrials.gov: NCT02582216 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Pain on the Visual Analog Scale (VAS) — 6.4; 4.0 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
3D augmented reality (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Erasme University Hospital
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain on the Visual Analog Scale (VAS)		 6.4; 4.0 —
SECONDARY
Neuropathic Pain Assessed With DN4 Questionnaire		 6.5; 5.5 —

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02582216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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