Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain

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

Study Overview

• Status: Withdrawn
• Conditions: Phantom Limb Pain
• Intervention / Treatment: Other: Virtual Mirror Therapy

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingahm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Unilateral upper extremity amputees; 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.

Other: Virtual Mirror Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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).	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).	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).	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).	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).	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).	12 weeks after final session (Session 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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.	Week 6 - Week 52

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Conley Carr, MD, The University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Mirror Therapy; Chronic Phantom Limb Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: IRB-300007560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No