Virtual Reality for Phantom Limb Pain

Phantom Limb Pain Clinical Trial

Official title:

Adapting Virtual Reality Technology for the Treatment of Phantom Limb Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784548
• Other study ID #: D1729-P
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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