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Clinical Trials/NCT02784548
NCT02784548
Completed
N/A

Adapting Virtual Reality Technology for the Treatment of Phantom Limb Pain

VA Office of Research and Development1 site in 1 country15 target enrollmentOctober 2, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Phantom Limb Pain
Sponsor
VA Office of Research and Development
Enrollment
15
Locations
1
Primary Endpoint
Phantom Limb Pain Questionnaire (PLPQ)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2017
End Date
September 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Phantom Limb Pain Questionnaire (PLPQ)

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

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.

Study Sites (1)

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