Clinical trial NCT05194800: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Phantom Limb Pain
Keywords: Virtual Mirror Therapy
Chronic Phantom Limb Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Baseline Numeric Rating Scale of Chronic Phantom Limb Pain
timeFrame: Baseline (Week 0)
measure: Change from Baseline Numeric Rating Scale at Session1
timeFrame: Week 1 - Week 52
measure: Change from Baseline Numeric Rating Scale at Session 2
timeFrame: Week 2 - Week 52
measure: Change from Baseline Numeric Rating Scale at Session 3
timeFrame: Week 3 - Week 52
measure: Change from Baseline Numeric Rating Scale at Session 4
timeFrame: Week 4 - Week 52
measure: Change from Baseline Numeric Rating Scale at Session 5
timeFrame: Week 5 - Week 52
measure: Change from Baseline Numeric Rating Scale at Session 6
timeFrame: Week 6 - Week 52
measure: Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain
timeFrame: Baseline (Week 0)
measure: Change from Baseline Pain Disability Questionnaire at Week 6
timeFrame: 6 weeks after final session (Session 6)
measure: Change from Baseline Pain Disability Questionnaire at Week 12
timeFrame: 12 weeks after final session (Session 6)
Secondary outcomes:
measure: Change in Quality from Baseline Chronic Phantom Limb Pain at Session1
timeFrame: Week 1 - Week 52
measure: Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2
timeFrame: Week 2 - Week 52
measure: Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3
timeFrame: Week 3 - Week 52
measure: Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4
timeFrame: Week 4 - Week 52
measure: Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5
timeFrame: Week 5 - Week 52
measure: Change in Quality from Baseline Chronic Phantom Limb Pain at Session 6
timeFrame: Week 6 - Week 52
measure: Impressions of change from Baseline Chronic Phantom Limb Pain at Session 6
timeFrame: Week 6 - Week 52
Other outcomes:
Locations:
Study officials:
affiliation: The University of Alabama at Birmingham
name: Conley Carr, MD
role: PRINCIPAL_INVESTIGATOR
References: