Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain
Primary Purpose
Phantom Limb Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Mirror Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring Virtual Mirror Therapy, Chronic Phantom Limb Pain
Eligibility Criteria
Inclusion Criteria:
- Presence of unilateral upper extremity amputation with continued intermittent or persistent phantom limb pain symptoms > 1 yr after amputation, pain must be >=4 of 10 on the VAS at least intermittently (i.e. can have no pain at times but they must at least have 4/10 intensity of pain when pain does occur).
Exclusion Criteria:
- Uncontrolled bipolar/schizophrenia, active psychosis, uncontrolled seizure disorder, history of severe simulator sickness, active nausea/vomiting, uncontrolled vertigo, bilateral blindness, any facial wounds around the cheeks nose or eyes that may interfere with headset, conjunctivitis, zoster ophthalmicus, immunodeficiency (uncontrolled HIV, immuno-suppressive medications, chemotherapy, etc), severe claustrophobia.
Sites / Locations
- The University of Alabama at Birmingahm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Unilateral upper extremity amputees
Arm Description
Unilateral upper extremity amputees suffering from chronic phantom limb pain > 1 yr will be recruited from a hospital based outpatient Physical Medicine and Rehabilitation Amputee Clinic at UAB.
Outcomes
Primary Outcome Measures
Baseline Numeric Rating Scale of Chronic Phantom Limb Pain
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) at Baseline to use as comparison to each study session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well.
Change from Baseline Numeric Rating Scale at Session1
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 2
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 3
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 4
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 5
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 6
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Change from Baseline Pain Disability Questionnaire at Week 6
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Change from Baseline Pain Disability Questionnaire at Week 12
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Secondary Outcome Measures
Change in Quality from Baseline Chronic Phantom Limb Pain at Session1
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 6
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Impressions of change from Baseline Chronic Phantom Limb Pain at Session 6
At the end of 6 sessions of Virtual Mirror Therapy subjects will be given the opportunity to submit opinions/comments regarding their impressions of the sessions.
Full Information
NCT ID
NCT05194800
First Posted
December 6, 2021
Last Updated
May 10, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05194800
Brief Title
Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain
Official Title
Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2024 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this project is to further investigate the use of Virtual Mirror therapy for alleviating symptoms of chronic phantom limb pain. This initial pilot study will inform a fully powered randomized control trial which will include both upper and lower extremity amputees
Detailed Description
Ten unilateral upper extremity amputees suffering from chronic phantom limb pain > 1 yr will be recruited from a hospital based outpatient Physical Medicine and Rehabilitation Amputee Clinic. There will be no control group and all 10 subjects will be offered the use of a Virtual Reality headset therapy game (developed in Unreal Engine using Oculus Quest 2 SDK). Fiducial markers will be placed on the residual limb for tracking via front facing cameras on the Oculus Quest 2 and the sound limb movements will be duplicated (flipped for chirality) and mapped onto the residual limb to provide the appearance of their residual limb. The software will direct the subjects through a series of guided movements, stretches, and visualization exercises which last a total of 15 minutes. Afterwards the subjects will be given 5 minutes of unstructured time in the program to perform any of exercises or movements they desire in order to attempt to relieve their phantom limb pain. Subjects will aim for 1 session per week for a total of 6 weeks. Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
Virtual Mirror Therapy, Chronic Phantom Limb Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unilateral upper extremity amputees
Arm Type
Experimental
Arm Description
Unilateral upper extremity amputees suffering from chronic phantom limb pain > 1 yr will be recruited from a hospital based outpatient Physical Medicine and Rehabilitation Amputee Clinic at UAB.
Intervention Type
Other
Intervention Name(s)
Virtual Mirror Therapy
Intervention Description
Subjects will be offered the use of a Virtual Reality headset therapy game. Fiducial markers will be placed on the residual limb for tracking via front facing cameras on the Oculus Quest 2 and the sound limb movements will be duplicated (flipped for chirality) and mapped onto the residual limb to provide the appearance of their residual limb. The software will direct the subjects through a series of guided movements, stretches, and visualization exercises which last a total of 15 minutes. Afterwards the subjects will be given 5 minutes of unstructured time in the program to perform any of exercises or movements they desire in order to attempt to relieve their phantom limb pain.
Primary Outcome Measure Information:
Title
Baseline Numeric Rating Scale of Chronic Phantom Limb Pain
Description
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) at Baseline to use as comparison to each study session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well.
Time Frame
Baseline (Week 0)
Title
Change from Baseline Numeric Rating Scale at Session1
Description
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Time Frame
Week 1 - Week 52
Title
Change from Baseline Numeric Rating Scale at Session 2
Description
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Time Frame
Week 2 - Week 52
Title
Change from Baseline Numeric Rating Scale at Session 3
Description
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Time Frame
Week 3 - Week 52
Title
Change from Baseline Numeric Rating Scale at Session 4
Description
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Time Frame
Week 4 - Week 52
Title
Change from Baseline Numeric Rating Scale at Session 5
Description
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Time Frame
Week 5 - Week 52
Title
Change from Baseline Numeric Rating Scale at Session 6
Description
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Time Frame
Week 6 - Week 52
Title
Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain
Description
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Time Frame
Baseline (Week 0)
Title
Change from Baseline Pain Disability Questionnaire at Week 6
Description
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Time Frame
6 weeks after final session (Session 6)
Title
Change from Baseline Pain Disability Questionnaire at Week 12
Description
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Time Frame
12 weeks after final session (Session 6)
Secondary Outcome Measure Information:
Title
Change in Quality from Baseline Chronic Phantom Limb Pain at Session1
Description
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Time Frame
Week 1 - Week 52
Title
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2
Description
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Time Frame
Week 2 - Week 52
Title
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3
Description
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Time Frame
Week 3 - Week 52
Title
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4
Description
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Time Frame
Week 4 - Week 52
Title
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5
Description
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Time Frame
Week 5 - Week 52
Title
Change in Quality from Baseline Chronic Phantom Limb Pain at Session 6
Description
Free-text section where participants can further describe any changes regarding their pain (change in quality etc).
Time Frame
Week 6 - Week 52
Title
Impressions of change from Baseline Chronic Phantom Limb Pain at Session 6
Description
At the end of 6 sessions of Virtual Mirror Therapy subjects will be given the opportunity to submit opinions/comments regarding their impressions of the sessions.
Time Frame
Week 6 - Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of unilateral upper extremity amputation with continued intermittent or persistent phantom limb pain symptoms > 1 yr after amputation, pain must be >=4 of 10 on the VAS at least intermittently (i.e. can have no pain at times but they must at least have 4/10 intensity of pain when pain does occur).
Exclusion Criteria:
Uncontrolled bipolar/schizophrenia, active psychosis, uncontrolled seizure disorder, history of severe simulator sickness, active nausea/vomiting, uncontrolled vertigo, bilateral blindness, any facial wounds around the cheeks nose or eyes that may interfere with headset, conjunctivitis, zoster ophthalmicus, immunodeficiency (uncontrolled HIV, immuno-suppressive medications, chemotherapy, etc), severe claustrophobia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conley Carr, MD
Phone
(205) 934-2747
Email
cjcarr@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conley Carr, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingahm
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain
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