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

NCT02582216 | Completed Phase 1 Results

• 1 other identifier: Kine-001
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neuropathic Pain Assessed With DN4 Questionnaire

  1 week

Other Outcomes (1)

• Questionnaire de Saint-Antoine

  1 week

Study Arms (1)

Open label

EXPERIMENTAL

3D augmented reality

Device: 3D augmented reality

Interventions

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.

Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Bilateral injury,
• Patients with epilepsy
• Side effects known to 3D (such as nausea, cephalalgia)
• Cognitive disorder
• Poor knowledge of the French language.

Sponsors & Collaborators

• Erasme University Hospital: lead

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dominique Mouraux
• Organization: Hôpital Erasme

dmouraux@ulb.ac.be

+32/2.555.38.48

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 21, 2015
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08