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

Primary Purpose

Neuralgia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

3D augmented reality

About this trial

This is an interventional treatment trial for Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label

Arm Description

3D augmented reality

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02582216

First Posted

October 1, 2015

Last Updated

August 11, 2020

Sponsor

Erasme University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02582216

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Erasme University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label

Arm Type

Experimental

Arm Description

3D augmented reality

Intervention Type

Device

Intervention Name(s)

3D augmented reality

Intervention Description

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 Outcome Measure Information:

Title

Pain on the Visual Analog Scale (VAS)

Description

Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain)

Time Frame

baseline and week

Secondary Outcome Measure Information:

Title

Neuropathic Pain Assessed With DN4 Questionnaire

Description

Time Frame

1 week

Other Pre-specified Outcome Measures:

Title

Questionnaire de Saint-Antoine

Description

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

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

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

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