Trial Outcomes & Findings for Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation (NCT NCT04529083)

NCT ID: NCT04529083

Last Updated: 2024-07-03

Results Overview

Pain intensity; 0-10; higher is worse

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: baseline, 1-month
• Results posted on: 2024-07-03

Participant Flow

Participant milestones

Measure	Intervention Mixed Reality System for virtual mirror therapy Mr. MAPP: Mixed reality device to provide virtual mirror therapy to patients with phantom pain
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Intervention Mixed Reality System for virtual mirror therapy Mr. MAPP: Mixed reality device to provide virtual mirror therapy to patients with phantom pain
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation

Baseline characteristics by cohort

Measure	Intervention n=11 Participants Mixed Reality System for virtual mirror therapy Mr. MAPP: Mixed reality device to provide virtual mirror therapy to patients with phantom pain
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	57.8 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1 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	4 Participants n=5 Participants
Race (NIH/OMB) White	7 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 United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 1-month

Pain intensity; 0-10; higher is worse

Outcome measures

Measure	Intervention n=8 Participants Mixed Reality System for virtual mirror therapy Mr. MAPP: Mixed reality device to provide virtual mirror therapy to patients with phantom pain
Change in Numerical Rating Scale Baseline	1.75 score on a scale Interval 1.0 to 5.0
Change in Numerical Rating Scale 1-month	1.125 score on a scale Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: baseline, 1-month

Pain intensity and interference; multiple scales; higher is worse. Range 0-78

Outcome measures

Measure	Intervention n=8 Participants Mixed Reality System for virtual mirror therapy Mr. MAPP: Mixed reality device to provide virtual mirror therapy to patients with phantom pain
Change in McGill Pain Questionnaire Baseline	38.5 score on a scale Interval 0.0 to 78.0
Change in McGill Pain Questionnaire 1-month	31.88 score on a scale Interval 0.0 to 78.0

SECONDARY outcome

Timeframe: baseline, 1-month

Patient specific functional questionnaire; multiple scales; higher is better; Range 0 to 10 for each activity

Outcome measures

Measure	Intervention n=8 Participants Mixed Reality System for virtual mirror therapy Mr. MAPP: Mixed reality device to provide virtual mirror therapy to patients with phantom pain
Change in Patient Specific Functional Questionnaire Baseline	4.28 score on a scale Interval 0.0 to 10.0
Change in Patient Specific Functional Questionnaire 1-month	6.22 score on a scale Interval 0.0 to 10.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. James Le Page

VA North Texas Health Care System

Phone: 214-857-1437

Email: james.lepage@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place