Virtual Reality Walking for Neuropathic Pain in Spinal Cord Injury

NCT03735017 | Completed

• 1 other identifier: 383546
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries; Neuropathic Pain

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (5)

• Pain Intensity as assessed by Numeric Rating Scale

  The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale. Range of scores: 0-10

  Baseline - Final assessment (average 1 week post treatment)

• Neuropathic Pain Qualities as assessed by Neuropathic Pain Scale

  The Neuropathic Pain Scale (NPS) was designed to assess the distinct pain qualities associated with neuropathic pain.The NPS consists of 10 items. Seven of the 10 items contain the words intense, sharp, hot, dull, cold, and itchy to characterize the patient's pain and the word sensitive to describe the patient's pain reaction to light touch or clothing.One item describes the time quality of the pain (all the time or some of the time). The ninth item describes the overall unpleasantness of the pain, whereas the last item indicates the intensity of the deep and surface pain. In the NPS each item is rated separately. All the items are rated 0-10 scale, with higher score indicative of more neuropathic pain for each type of respective pain. Range of scores: 0-10 for each item.

  Baseline - Final assessment (average 1 week post treatment)

• Neuropathic Pain Diagnosis as assessed by Doleur Neuropatique 4

  Doleur Neuropatique 4 is a 10 item survey that evaluates neuropathic pain following central and neurological lesions. It has components of how the pain feels to the patient (e.g. burning, cold, electrical shocks, tingling, hypoaesthesia). Responses to each item is yes or no, with each yes response equaling one point. Range of scores: 0-10. 4/10 and greater indicate neuropathic pain.

  Baseline - Final assessment (average 1 week post treatment)

• Pain Interference specific to spinal cord injury as assessed by International Spinal Cord Injury Pain Basic Data Set version 2.0

  Pain interference measured International Spinal Cord Injury Pain Basic Data Set version 2.0 interference items. There are 3 pain interference items using a 0-10 numeric rating scale for each item. Items can be assessed by summing the score or by individual assessment of items. Summed range of scores: 0-30. Individual item range of scores: 0-10

  Baseline - Final assessment (average 1 week post treatment)

• Pain Interference as assessed by Brief Pain Inventory

  Pain interference measured by Brief Pain Inventory interference items. 7 items each use a 0-10 scale. Item scores may be assessed individually, or by taking the average score of all items. Range of Scores: 0-10. Increased scores indicate higher levels of interference due to pain.

  Baseline - Final assessment (average 1 week post treatment)

Secondary Outcomes (11)

• Patient Treatment Evaluation as assessed by the Ease of Usefulness, Satisfaction, and Ease of Use Questionnaire

  Final assessment (average 1 week post treatment)

• Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale

  Final assessment (average 1 week post treatment)

• Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory

  Final assessment (average 1 week post treatment)

• Patient Treatment Evaluation as assessed by Semi-structured Qualitative Interviewing

  Final assessment (average 1 week post treatment)

• Quality of Life and Participation are assessed by the SF-36 Walk-Wheel

  Baseline - Final assessment (average 1 week post treatment)

Study Arms (2)

Non-Interactive

ACTIVE COMPARATOR

Participants will receive non-interactive virtual reality walking sessions.

Other: Non-Interactive Virtual Reality Walking

Interactive

EXPERIMENTAL

Participants will receive interactive virtual reality walking sessions.

Other: Interactive Virtual Reality Walking

Interventions

Non-Interactive Virtual Reality Walking 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.

Non-Interactive

Interactive Virtual Reality Walking 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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 34407034 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zina Trost, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and key research staff assessing outcomes will be blind to condition allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 8, 2018
• Study Start: June 16, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)