The Impact of a Virtual Reality Environment on Phantom Limb Pain

NCT03934528 | Withdrawn

• 1 other identifier: IRAS:259344
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Phantom Limb Pain; Virtual Reality; Virtual Environment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Pilot Study

EXPERIMENTAL

Device: Virtual environment activity

Interventions

Virtual environment activity DEVICE

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

Pilot Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 2, 2019
• Study Start: June 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

GB (1)