Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain

NCT05194800 | Withdrawn

• 1 other identifier: IRB-300007560
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Phantom Limb Pain

Keywords

Virtual Mirror Therapy; Chronic Phantom Limb Pain

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• Change in Quality from Baseline Chronic Phantom Limb Pain at Session1

  Week 1 - Week 52

• Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2

  Week 2 - Week 52

• Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3

  Week 3 - Week 52

• Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4

  Week 4 - Week 52

• Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5

  Week 5 - Week 52

Study Arms (1)

Unilateral upper extremity amputees

EXPERIMENTAL

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

Interventions

Virtual Mirror Therapy OTHER

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.

Unilateral upper extremity amputees

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Conley Carr, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 18, 2022
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share