Virtual Reality Walking for Neuropathic Pain in Spinal Cord Injury

NCT ID: NCT03735017

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-16

Study Completion Date

2019-07-30

Brief Summary

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This study will examine the effectiveness of one of two virtual reality treatments on neuropathic pain in individuals with spinal cord injury.

Detailed Description

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The investigators are investigating the effectiveness of one of two possible investigational virtual reality treatments on neuropathic pain in individuals with spinal cord injury. Participants will be randomized to one of these two treatments.

Conditions

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Spinal Cord Injuries Neuropathic Pain

Keywords

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Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of two intervention arms. Both groups receive the same number of sessions, duration of sessions, and measures procured.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and key research staff assessing outcomes will be blind to condition allocation.

Study Groups

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Non-Interactive

Participants will receive non-interactive virtual reality walking sessions.

Group Type ACTIVE_COMPARATOR

Non-Interactive Virtual Reality Walking

Intervention Type OTHER

Individuals will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.

Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.

Interactive

Participants will receive interactive virtual reality walking sessions.

Group Type EXPERIMENTAL

Interactive Virtual Reality Walking

Intervention Type OTHER

Individuals will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.

Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.

Interventions

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Non-Interactive Virtual Reality Walking

Individuals will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.

Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.

Intervention Type OTHER

Interactive Virtual Reality Walking

Individuals will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.

Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals with complete paraplegic spinal cord injury who report chronic neuropathic pain
* Individuals with persistent spinal cord injury neuropathic pain
* More than one - year post injury
* Stable medication regimen for the past month

Exclusion Criteria

* Conditions that impair movement of the arms
* Significant cognitive impairment as suggested by apparent incomprehension of screening questions as judged by the evaluator
* For those for whom voluntary arm movement would cause sufficient discomfort (\>4/10) that could prevent trial completion will be excluded from participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Zina Trost

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zina Trost, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Trost Z, Anam M, Seward J, Shum C, Rumble D, Sturgeon J, Mark V, Chen Y, Mitchell L, Cowan R, Perera R, Richardson E, Richards S, Gustin S. Immersive interactive virtual walking reduces neuropathic pain in spinal cord injury: findings from a preliminary investigation of feasibility and clinical efficacy. Pain. 2022 Feb 1;163(2):350-361. doi: 10.1097/j.pain.0000000000002348.

Reference Type DERIVED
PMID: 34407034 (View on PubMed)

Other Identifiers

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383546

Identifier Type: -

Identifier Source: org_study_id