Trial Outcomes & Findings for Virtual Reality for Phantom Limb Pain (NCT NCT02784548)

NCT ID: NCT02784548

Last Updated: 2019-09-17

Results Overview

The PLPQ assesses the severity of PLP, stump pain and phantom limb sensation. Severity is assessed on a standard 11-point Likert scale pain measure, range 0-10 with higher scores indicating greater PLP.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: PLPQ scores before versus after initial use of the VR treatment in the laboratory
• Results posted on: 2019-09-17

Participant Flow

Participant milestones

Measure	Virtual Reality Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Virtual Reality n=15 Participants Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=15 Participants
Age, Categorical >=65 years	3 Participants n=15 Participants
Age, Continuous	63.0 years STANDARD_DEVIATION 12.6 • n=15 Participants
Sex: Female, Male Female	1 Participants n=15 Participants
Sex: Female, Male Male	14 Participants n=15 Participants
Region of Enrollment United States	15 Participants n=15 Participants

PRIMARY outcome

Timeframe: PLPQ scores before versus after initial use of the VR treatment in the laboratory

Population: Veterans with PLP. The mirror therapy group was a pre-specified control group that was not completed due to recruitment challenges.

The PLPQ assesses the severity of PLP, stump pain and phantom limb sensation. Severity is assessed on a standard 11-point Likert scale pain measure, range 0-10 with higher scores indicating greater PLP.

Outcome measures

Measure	Virtual Reality n=15 Participants Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.	Mirror Therapy Mirror Therapy comparison group
Phantom Limb Pain Questionnaire (PLPQ) Pre-VR use	1.2 units on a scale Standard Deviation 1.6	—
Phantom Limb Pain Questionnaire (PLPQ) Post-VR use	.5 units on a scale Standard Deviation .94	—

Adverse Events

Virtual Reality

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. Thomas Rutledge

VA San Diego Healthcare System

Phone: 8585528585

Email: thomas.rutledge@va.gov

Results disclosure agreements

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