The Impact of a Virtual Reality Environment on Phantom Limb Pain

Not Applicable

Withdrawn

• Conditions: Phantom Limb Syndrome With Pain
• Interventions: Device: Virtual environment activity

• Registration Number: NCT03934528
• Lead Sponsor: University of Manchester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Study Start: 2019-06
• Primary Completion: 2019-09
• Study Completion: 2019-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot Study	Virtual environment activity	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom