The Impact of a Virtual Reality Environment on Phantom Limb Pain

U

University of Manchester

Status

Unknown

Conditions

Phantom Limb Syndrome With Pain

Treatments

Device: Virtual environment activity

Study type

Interventional

Funder types

Other

Identifiers

NCT03934528
IRAS:259344

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Pilot Study
Experimental group
Treatment:
Device: Virtual environment activity

Trial contacts and locations

0

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Central trial contact

Stephen R Pettifer, PhD

Data sourced from clinicaltrials.gov

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