Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain
- Conditions
- Phantom Limb Pain
- Interventions
- Other: Virtual Mirror Therapy
- Registration Number
- NCT05194800
- Lead Sponsor
- University of Alabama at Birmingham
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Unilateral upper extremity amputees Virtual Mirror Therapy 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.
- Primary Outcome Measures
Name Time Method Change from Baseline Numeric Rating Scale at Session 2 Week 2 - Week 52 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 Numeric Rating Scale of Chronic Phantom Limb Pain Baseline (Week 0) 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 Week 1 - Week 52 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 Pain Disability Questionnaire at Week 6 6 weeks after final session (Session 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 Numeric Rating Scale at Session 3 Week 3 - Week 52 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 Week 4 - Week 52 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 Week 5 - Week 52 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 Week 6 - Week 52 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 Baseline (Week 0) 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 12 weeks after final session (Session 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).
- Secondary Outcome Measures
Name Time Method Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2 Week 2 - Week 52 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 Week 4 - Week 52 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 Week 3 - Week 52 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 Week 5 - Week 52 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 Session1 Week 1 - Week 52 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 Week 6 - Week 52 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 Week 6 - Week 52 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.