Clinical trial NCT02784548: Virtual Reality for Phantom Limb Pain
Official title: Adapting Virtual Reality Technology for the Treatment of Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb Pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-05-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Phantom Limb Pain Questionnaire (PLPQ)
timeFrame: PLPQ scores before versus after initial use of the VR treatment in the laboratory
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Thomas R. Rutledge, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: