Trial Outcomes & Findings for 3D Augmented Reality Mirror Visual Feedback Applied to the Treatment of Unilateral Upper Extremity Neuropathic Pain. (NCT NCT02582216)
NCT ID: NCT02582216
Last Updated: 2020-08-24
Results Overview
Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain)
COMPLETED
PHASE1/PHASE2
22 participants
baseline and week
2020-08-24
Participant Flow
Participant milestones
| Measure |
Open Label
3D augmented reality
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3D Augmented Reality Mirror Visual Feedback Applied to the Treatment of Unilateral Upper Extremity Neuropathic Pain.
Baseline characteristics by cohort
| Measure |
Open Label
n=22 Participants
3D augmented reality
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and weekVisual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain)
Outcome measures
| Measure |
Open Label
n=22 Participants
each patients received 5 3D augmented reality over a period of 5 days. Each treatment lasted a total of 20 minutes
|
|---|---|
|
Pain on the Visual Analog Scale (VAS)
vas baseline
|
6.4 units on a scale
Standard Deviation 2.3
|
|
Pain on the Visual Analog Scale (VAS)
vas after 1 week
|
4.0 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 1 weekDN4 (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
Outcome measures
| Measure |
Open Label
n=22 Participants
each patients received 5 3D augmented reality over a period of 5 days. Each treatment lasted a total of 20 minutes
|
|---|---|
|
Neuropathic Pain Assessed With DN4 Questionnaire
24H after the last treatment
|
5.5 units on a scale
Standard Deviation 2.3
|
|
Neuropathic Pain Assessed With DN4 Questionnaire
before
|
6.5 units on a scale
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekFrench 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
Outcome measures
Outcome data not reported
Adverse Events
Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place