The Impact of a Virtual Reality Environment on Phantom Limb Pain

NCT ID: NCT03934528

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2019-11-30

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.

Conditions

Phantom Limb Syndrome With Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilot Study

Group Type: EXPERIMENTAL

Virtual environment activity

Intervention Type: DEVICE

Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months

Interventions

Virtual environment activity

Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Stephen Pettifer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS:259344

Identifier Type: -

Identifier Source: org_study_id