The Impact of a Virtual Reality Environment on Phantom Limb Pain

Study Overview
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Brief Summary
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Phantom limb pain occurs in the majority of people who lose a limb. It significantly affects quality of life and is hard to manage. Recent evidence suggests that mirror therapy and similar techniques that create a visual representation of the missing limb under the control of the patient may reduce phantom limb pain. The investigators previously explored the use of a virtual reality environment for this purpose with people with upper limb loss but found that using it within the clinical setting limited its potential efficacy. Phantom limb pain is highly variable and assessing the effects of the activity during a hospital appointment when the phantom pain may not be present, or may not be problematic, made it difficult to judge the effects adequately. This study involves training the patient in the clinic to use a portable, self-contained virtual reality system which they will then use at home, unsupervised, for 2 months. The aim is to discover whether phantom limb pain intensity decreases by performing an activity in a virtual reality environment in which a visual representation of the missing limb is controlled by the patient. Participants will be directed to use the system every day, and whenever their phantom limb pain is present and problematic.

Official Title
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The Impact of Simulated Arm Movement Within a Virtual Reality Environment on Phantom Limb Pain in Upper Limb Amputees: A Pilot Study

Conditions
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Phantom Limb Syndrome With Pain

Intervention / Treatment
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* Device: Virtual environment activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age. Unilateral upper limb amputee (transradial and transhumeral). Amputation occurred at least 6 months ago. Stump has fully healed and has no ulcerations present. Exclusion Criteria: Amputation of digit(s) only. The presence of a wound, ulcer or broken skin on the residual limb. The presence of a psychiatric disorder. Have pre-existing binocular vision abnormalities. A history of seizures or epilepsy. A pacemaker or other implanted medical device that could be affected by magnets or components that emit radio waves. Lacking the capacity to understand the instructions on how to use the virtual reality equipment. Lacking the capacity to consent. Unable to comply with the requirements of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Study<br> | Device: Virtual environment activity<br>* Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of number of phantom limb pain episodes per month. |  | 2 months | 
| Change from baseline of average duration of phantom limb pain episodes. |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phantom Limb Pain, Virtual Reality, Virtual Environment