WithdrawnNot Applicable

The Impact of a Virtual Reality Environment on Phantom Limb Pain

Stopped: Unable to proceed during lockdown; post-lockdown vendor no longer supports the hardware on which the study was developed

United Kingdom0Started 2019-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT03934528

SponsorUniversity of Manchester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09

View on ClinicalTrials.gov More Phantom Limb Syndrome With Pain trials