The Impact of a Virtual Reality Environment on Phantom Limb Pain
Primary Purpose
Phantom Limb Syndrome With Pain
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual environment activity
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Syndrome With Pain focused on measuring Phantom Limb Pain, Virtual Reality, Virtual Environment
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.
Sites / Locations
- Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot Study
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain.
Secondary Outcome Measures
Change from baseline of number of phantom limb pain episodes per month.
Change from baseline of average duration of phantom limb pain episodes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03934528
Brief Title
The Impact of a Virtual Reality Environment on Phantom Limb Pain
Official Title
The Impact of Simulated Arm Movement Within a Virtual Reality Environment on Phantom Limb Pain in Upper Limb Amputees: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Syndrome With Pain
Keywords
Phantom Limb Pain, Virtual Reality, Virtual Environment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilot Study
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Virtual environment activity
Intervention Description
Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change from baseline of number of phantom limb pain episodes per month.
Time Frame
2 months
Title
Change from baseline of average duration of phantom limb pain episodes.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen R Pettifer, PhD
Phone
+44 161 275 6259
Email
steve.pettifer@manchester.ac.uk
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jai Kulkarni
Email
jai.kulkarni@mft.nhs.uk
First Name & Middle Initial & Last Name & Degree
Jai Kulkarni
12. IPD Sharing Statement
Learn more about this trial
The Impact of a Virtual Reality Environment on Phantom Limb Pain
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