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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
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.
Time frame: Baseline (Week 0)
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).
Time frame: Week 1 - Week 52
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).
Time frame: Week 2 - Week 52
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).
Time frame: Week 3 - Week 52
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).
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Time frame: Week 4 - Week 52
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).
Time frame: Week 5 - Week 52
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).
Time frame: Week 6 - Week 52
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).
Time frame: Baseline (Week 0)
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).
Time frame: 6 weeks after final session (Session 6)
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).
Time frame: 12 weeks after final session (Session 6)
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).
Time frame: Week 1 - Week 52
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).
Time frame: Week 2 - Week 52
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).
Time frame: Week 3 - Week 52
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).
Time frame: Week 4 - Week 52
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).
Time frame: Week 5 - Week 52
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).
Time frame: Week 6 - Week 52
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.
Time frame: Week 6 - Week 52