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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

The Impact of a Virtual Reality Environment on Phantom Limb Pain

Clinicaltrials.gov identifier NCT03934528

Recruitment Status Not yet recruiting

First Posted May 2, 2019

Last update posted May 20, 2019

Study Description

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.

  • Condition or Disease:Phantom Limb Syndrome With Pain
  • Intervention/Treatment: Device: Virtual environment activity
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: The Impact of Simulated Arm Movement Within a Virtual Reality Environment on Phantom Limb Pain in Upper Limb Amputees: A Pilot Study
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: November 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Pilot Study
Device: Virtual environment activity
Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months
Outcome Measures
  • Primary Outcome Measures: 1. Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain. [ Time Frame: 2 months ]
  • Secondary Outcome Measures: 1. Change from baseline of number of phantom limb pain episodes per month. [ Time Frame: 2 months ]
  • 2. Change from baseline of average duration of phantom limb pain episodes. [ Time Frame: 2 months ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts

Contact: Stephen R Pettifer, PhD +44 161 275 6259 steve.pettifer@manchester.ac.uk

Locations

United Kingdom
Manchester University NHS Foundation Trust
Manchester

Sponsors and Collaborators

University of Manchester

More Information
  • Responsible Party: University of Manchester
  • ClinicalTrials.gov Identifier: NCT03934528 History of Changes
  • Other Study ID Numbers: IRAS:259344
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: May 20, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Manchester: Phantom Limb Pain
    Virtual Reality
    Virtual Environment
  • Additional relevant MeSH terms: Phantom Limb