Virtual Reality for Phantom Limb Pain

NCT ID: NCT02784548

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2018-09-30

Brief Summary

This study will develop a virtual reality-based treatment for phantom limb pain among Veterans and test it against the most established behavioral therapy for phantom limb pain, mirror therapy.

Detailed Description

The VA system performs more than 10% of all amputations in the U.S., a percentage translating into more than 50,000 upper and lower extremity amputations in the past decade. Among Veterans with amputations, research suggests that upwards of 70% experience phantom limb pain (PLP), an often chronic and debilitating condition with adverse effects on quality of life and poor responsiveness to conventional pain treatments. The use of virtual reality technology for chronic pain management is a novel and rapidly advancing area of study, with existing research suggesting that virtual reality treatments are effective for acute pain management, promising for chronic pain management, and as yet untested for PLP. In the current study, the investigators will develop a virtual reality environment that simulates mirror therapy - the gold standard behavioral treatment for PLP - comparing the efficacy of this modality in a population of Veterans with PLP against a standard mirror therapy treatment validated by this research team in a previously supported clinical trial.

Conditions

Phantom Limb Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

Using a 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.

Interventions

Virtual Reality

Using a 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages 21-75 Veteran receiving care at VA San Diego Healthcare System
• Upper or lower extremity amputation with reported PLP for at least six months
• PLP intensity > 3/10
• English-speaking, literate, with stable residence
• Able to operate a VR headset as evidenced by direct observation

Exclusion Criteria

• Major medical illness that might confound effects of pain on function, e.g.:

• advanced cardiac
• pulmonary disease
• current active alcohol or substance use disorder as evidenced from medical record
• currently active suicidality
• homicidality, or unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
• moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
• prior mirror therapy experience

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R. Rutledge, PhD MA

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D1729-P

Identifier Type: -

Identifier Source: org_study_id