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Virtual Reality for Phantom Limb Pain

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VA Office of Research and Development

Status

Completed

Conditions

Phantom Limb Pain

Treatments

Other: Virtual Reality

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02784548
D1729-P

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Virtual reality
Experimental group
Description:
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.
Treatment:
Other: Virtual Reality

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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