Phantom Limb Pain
Conditions
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.
Interventions
OTHERVirtual 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phantom Limb Pain Questionnaire (PLPQ) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Reality 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Virtual Reality | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 12.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 Participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: PLPQ scores before versus after initial use of the VR treatment in the laboratory
Population: Veterans with PLP. The mirror therapy group was a pre-specified control group that was not completed due to recruitment challenges.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Reality | Phantom Limb Pain Questionnaire (PLPQ) | Pre-VR use | 1.2 units on a scale | Standard Deviation 1.6 |
| Virtual Reality | Phantom Limb Pain Questionnaire (PLPQ) | Post-VR use | .5 units on a scale | Standard Deviation 0.94 |