The Impact of a Virtual Reality Environment on Phantom Limb Pain

Phantom Limb Syndrome With Pain Clinical Trial

Official title:

The Impact of Simulated Arm Movement Within a Virtual Reality Environment on Phantom Limb Pain in Upper Limb Amputees: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03934528
• Other study ID #: IRAS:259344
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2019
• Est. completion date: November 2019

Study information

• Verified date: May 2019
• Source: University of Manchester
• Contact: Stephen R Pettifer, PhD
• Phone: +44 161 275 6259
• Email: steve.pettifer[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Syndrome With Pain

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline of number of phantom limb pain episodes per month.		2 months
Secondary	Change from baseline of average duration of phantom limb pain episodes.		2 months