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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuralgia
• Intervention / Treatment: Device: 3D augmented reality

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Open label; 3D augmented reality

Device: 3D augmented reality; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on the Visual Analog Scale (VAS)	Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain)	baseline and week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic Pain Assessed With DN4 Questionnaire	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	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire de Saint-Antoine	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	1 week

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (ESTIMATE): October 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: Kine-001