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Completed

NCT Number: NCT02582216

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

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.

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Key information

Conditions

Neuralgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D augmented reality

Device

Each treatment period included a 3DARS (3D augmented reality system)training session.All 3DARS training sessions were performed in the same quiet room under the supervision of the same single investigator.The 3DARS training session protocol included two virtual training procedures. The first virtual training procedure consisted of applying a vertical virtual mirror to the display screen, where the non-affected side of the patient's body (such as the right) was symmetrically duplicated by a vertical axis on the affected side (such as the left).The second virtual training procedure consisted of flipping the 3D image horizontally along a vertical axis. This allowed patients to observe the reflection of their non-affected upper extremity as if it was the affected one.

Primary outcomes

  1. 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

  1. Neuropathic Pain Assessed With DN4 Questionnaire

    Time frame: 1 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

Other outcomes

  1. Questionnaire de Saint-Antoine

    Time frame: 1 week

    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

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 21, 2015
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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