Clinical trial NCT03934528: The Impact of a Virtual Reality Environment on Phantom Limb Pain
Official title: The Impact of Simulated Arm Movement Within a Virtual Reality Environment on Phantom Limb Pain in Upper Limb Amputees: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Phantom Limb Syndrome With Pain
Keywords: Phantom Limb Pain
Virtual Reality
Virtual Environment
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain.
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline of number of phantom limb pain episodes per month.
timeFrame: 2 months
measure: Change from baseline of average duration of phantom limb pain episodes.
timeFrame: 2 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References: