Virtual Reality for Phantom Limb Pain

NCT02784548 | Completed Results

• 1 other identifier: D1729-P
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• Phantom Limb Pain Questionnaire (PLPQ)

  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.

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

Study Arms (1)

Virtual reality

EXPERIMENTAL

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.

Other: Virtual Reality

Interventions

Virtual Reality 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.

Virtual reality

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Limitations and Caveats

As noted in the results section, this study did not contain long-term follow-up or enroll the a prior planned mirror therapy control group due to recruitment limitations.

Results Point of Contact

• Title: Dr. Thomas Rutledge
• Organization: VA San Diego Healthcare System

thomas.rutledge@va.gov

8585528585

Study Officials

• Thomas R. Rutledge, PhD MA

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 27, 2016
• Study Start: October 2, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 17, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)