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

• Sponsor: Erasme University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02582216
• Collaborator: (none)
• Enrollment: 22
• Arm: 1
• Duration (Months): 9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neuralgia	Device: 3D augmented reality	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 3D Augmented Reality Mirror Visual Feedback Therapy Applied to the Treatment of Persistent, Unilateral Upper Extremity Neuropathic Pain: A Preliminary Study
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pain on the Visual Analog Scale (VAS) [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 Outcome Measures

1. Neuropathic Pain Assessed With DN4 Questionnaire [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 Outcome Measures

1. Questionnaire de Saint-Antoine [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erasme University Hospital
• ClinicalTrials.gov Identifier: NCT02582216
• Other Study ID Numbers: Kine-001
• First Posted: Oct 21, 2015
• Last Update Posted: Aug 24, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Neuralgia

Study Results

Participant Flow

Arm/Group Title	Open Label
Arm/Group Description	3D augmented reality
Period Title: Overall Study
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Open Label
Arm/Group Description	3D augmented reality
Overall Participants	22
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 86.4%
>=65 years	3 13.6%
Sex: Female, Male (Count of Participants)
Female	12 54.5%
Male	10 45.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 13.6%
White	19 86.4%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Belgium	22 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label
Arm/Group Description	each patients received 5 3D augmented reality over a period of 5 days. Each treatment lasted a total of 20 minutes
Measure Participants	22
vas baseline	6.4 (2.3)
vas after 1 week	4.0 (2.4)

2. Secondary Outcome

Title	Neuropathic Pain Assessed With DN4 Questionnaire
Description	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
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label
Arm/Group Description	Each patient received a 3D augmented reality
Measure Participants	22
before	6.5 (2.3)
24H after the last treatment	5.5 (2.3)

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	Virtual training activities were terminated if patients complained about the development of headache or nausea, which are the most common side effects provoked by the use of stereovision systems similar to the 3DARS system. These symptoms were not present in this population.
Arm/Group Title	Open Label
Arm/Group Description	patients received a 3D augmented reality treatment
All Cause Mortality
	Open Label
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Open Label
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Other (Not Including Serious) Adverse Events
	Open Label
	Affected / at Risk (%)	# Events
Total	0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.