Clinical trial NCT03735017: Virtual Reality Walking for Neuropathic Pain in Spinal Cord Injury
Official title: Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Keywords: Virtual Reality
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity as assessed by Numeric Rating Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Neuropathic Pain Qualities as assessed by Neuropathic Pain Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Neuropathic Pain Diagnosis as assessed by Doleur Neuropatique 4
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Pain Interference specific to spinal cord injury as assessed by International Spinal Cord Injury Pain Basic Data Set version 2.0
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Pain Interference as assessed by Brief Pain Inventory
timeFrame: Baseline - Final assessment (average 1 week post treatment)
Secondary outcomes:
measure: Patient Treatment Evaluation as assessed by the Ease of Usefulness, Satisfaction, and Ease of Use Questionnaire
timeFrame: Final assessment (average 1 week post treatment)
measure: Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
timeFrame: Final assessment (average 1 week post treatment)
measure: Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
timeFrame: Final assessment (average 1 week post treatment)
measure: Patient Treatment Evaluation as assessed by Semi-structured Qualitative Interviewing
timeFrame: Final assessment (average 1 week post treatment)
measure: Quality of Life and Participation are assessed by the SF-36 Walk-Wheel
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Quality of Life is assessed by Satisfaction with Life Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Depression and mood are assessed by the Patient Health Questionnaire -9
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Perceived Disability is assessed by the Pain Disability Index
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Absorption is assessed by the Tellegen Absorption Scale
timeFrame: Baseline
measure: Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire
timeFrame: Baseline
measure: fMRI Imaging
timeFrame: Baseline - Final assessment (average 1 week post treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Zina Trost, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.