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Virtual Reality Walking for Neuropathic Pain in Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-Interactive Virtual Reality Walking
Interactive Virtual Reality Walking
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Virtual Reality

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-Interactive

Interactive

Arm Description

Participants will receive non-interactive virtual reality walking sessions.

Participants will receive interactive virtual reality walking sessions.

Outcomes

Primary Outcome Measures

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
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.
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.
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
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.

Secondary Outcome Measures

Patient Treatment Evaluation as assessed by the Ease of Usefulness, Satisfaction, and Ease of Use Questionnaire
Ease of Usefulness, Satisfaction, and Ease of use Questionnaire is a 30 item survey. Subscales include: treatment's usefulness, ease of use, ease of learning, and satisfaction. Each item is presented on a 7-point Likert scale. Each subscale is calculated by averaging all items in subscale. Range of scores for each subscale: 1-7
Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
Patient treatment evaluation is assessed by the Patient Global Impression of Change. This is a one item 7 point Likert item assessing improvement of the participants overall status. Range of scores: 1-7
Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
Patient treatment evaluation is assessed by Treatment Evaluation Inventory. This is a 9 item scale with a 5-point Likert responses for each question. The items are scored by summing all items. Range of scores: 9-45. A higher score indicates greater acceptance of treatment.
Patient Treatment Evaluation as assessed by Semi-structured Qualitative Interviewing
Patient treatment evaluation is assessed by semi-structured interviewing. Qualitative feedback from participant experience will be assessed by thematic analyses.
Quality of Life and Participation are assessed by the SF-36 Walk-Wheel
Quality of life and participation are assessed by the SF-Walk Wheel. This is a 36 item assess health concepts which represent basic human values and were relevant to a person's functional status and well-being. The responses are based on a Likert scale. There are the following subscales: Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each item is recoded to a preset value between 0-100 per the scoring key. Range of scores: 0-100 for each sub-scale. A higher score defines a more favorable health state.
Quality of Life is assessed by Satisfaction with Life Scale
Quality of life is assessed by the Satisfaction with Life Scale. This is a 5 item survey. Response options are a 7-point Likert scale. Items may be assessed individually or by summing items. Range of scores: 5-35. Higher scores indicate more satisfaction in life
Depression and mood are assessed by the Patient Health Questionnaire -9
Depression and mood are measured by Patient Health Questionnaire-9. This is a 10 item tool. The first 9 items are a 4-point Likert scale assessing depressive symptoms. The first 9 items are summed to determine depressive symptom severity. Item 10 assesses difficulty dealing with items 1-9. Item 10 is not used in scoring severity. Range of scores: 0-27. Higher scores indicate more depressive symptom severity.
Perceived Disability is assessed by the Pain Disability Index
Perceived Disability measured by a modified Pain Disability Index. The rating scales are designed to measure the degree to which aspects of life are disrupted by chronic pain. This is a 7 item survey with response options of 0-10. Each item may be assessed individually, or by summing all items. Individual item range of scores: 0-10 Total range of scores: 0-70. The higher the index, the greater the person's disability due to pain.
Absorption is assessed by the Tellegen Absorption Scale
Tellegen Absorption Scale is a 34-item multi-dimensional measure that assesses imaginative involvement and the tendency to become mentally absorbed in everyday activities. Item responses are on a 5-point Likert scale. Items are summed to score. Range of scores: 0-136. Higher scores indicate greater levels of absorption.
Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire
Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire (ITQ). This is an 18-item survey. Item responses use a 7 point Likert scale. Subscales include: focus, involvement, emotions, and play. Each subscale is scored by summing items. A total score is scored by summing all items. Range of total score: 18-126 Focus range of scores: 5-35 Involvement range of scores: 5-35 Emotions range of scores: 4-28 Play range of scores: 3-21 Higher scores indicate higher immersive tendencies overall and in each sub-scale.
fMRI Imaging
We are studying pain by functional Magnetic Resonance Imaging (fMRI) which allows us to identify certain parts of the brain that show how the brain works in controlling pain perception and cognitions.

Full Information

First Posted
October 31, 2018
Last Updated
November 15, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03735017
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 16, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Neuropathic Pain
Keywords
Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and key research staff assessing outcomes will be blind to condition allocation.
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Interactive
Arm Type
Active Comparator
Arm Description
Participants will receive non-interactive virtual reality walking sessions.
Arm Title
Interactive
Arm Type
Experimental
Arm Description
Participants will receive interactive virtual reality walking sessions.
Intervention Type
Other
Intervention Name(s)
Non-Interactive Virtual Reality Walking
Intervention Description
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
Intervention Name(s)
Interactive Virtual Reality Walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity as assessed by Numeric Rating Scale
Description
The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale. Range of scores: 0-10
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Neuropathic Pain Qualities as assessed by Neuropathic Pain Scale
Description
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.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Neuropathic Pain Diagnosis as assessed by Doleur Neuropatique 4
Description
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.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Pain Interference specific to spinal cord injury as assessed by International Spinal Cord Injury Pain Basic Data Set version 2.0
Description
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
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Pain Interference as assessed by Brief Pain Inventory
Description
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.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Secondary Outcome Measure Information:
Title
Patient Treatment Evaluation as assessed by the Ease of Usefulness, Satisfaction, and Ease of Use Questionnaire
Description
Ease of Usefulness, Satisfaction, and Ease of use Questionnaire is a 30 item survey. Subscales include: treatment's usefulness, ease of use, ease of learning, and satisfaction. Each item is presented on a 7-point Likert scale. Each subscale is calculated by averaging all items in subscale. Range of scores for each subscale: 1-7
Time Frame
Final assessment (average 1 week post treatment)
Title
Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
Description
Patient treatment evaluation is assessed by the Patient Global Impression of Change. This is a one item 7 point Likert item assessing improvement of the participants overall status. Range of scores: 1-7
Time Frame
Final assessment (average 1 week post treatment)
Title
Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
Description
Patient treatment evaluation is assessed by Treatment Evaluation Inventory. This is a 9 item scale with a 5-point Likert responses for each question. The items are scored by summing all items. Range of scores: 9-45. A higher score indicates greater acceptance of treatment.
Time Frame
Final assessment (average 1 week post treatment)
Title
Patient Treatment Evaluation as assessed by Semi-structured Qualitative Interviewing
Description
Patient treatment evaluation is assessed by semi-structured interviewing. Qualitative feedback from participant experience will be assessed by thematic analyses.
Time Frame
Final assessment (average 1 week post treatment)
Title
Quality of Life and Participation are assessed by the SF-36 Walk-Wheel
Description
Quality of life and participation are assessed by the SF-Walk Wheel. This is a 36 item assess health concepts which represent basic human values and were relevant to a person's functional status and well-being. The responses are based on a Likert scale. There are the following subscales: Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each item is recoded to a preset value between 0-100 per the scoring key. Range of scores: 0-100 for each sub-scale. A higher score defines a more favorable health state.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Quality of Life is assessed by Satisfaction with Life Scale
Description
Quality of life is assessed by the Satisfaction with Life Scale. This is a 5 item survey. Response options are a 7-point Likert scale. Items may be assessed individually or by summing items. Range of scores: 5-35. Higher scores indicate more satisfaction in life
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Depression and mood are assessed by the Patient Health Questionnaire -9
Description
Depression and mood are measured by Patient Health Questionnaire-9. This is a 10 item tool. The first 9 items are a 4-point Likert scale assessing depressive symptoms. The first 9 items are summed to determine depressive symptom severity. Item 10 assesses difficulty dealing with items 1-9. Item 10 is not used in scoring severity. Range of scores: 0-27. Higher scores indicate more depressive symptom severity.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Perceived Disability is assessed by the Pain Disability Index
Description
Perceived Disability measured by a modified Pain Disability Index. The rating scales are designed to measure the degree to which aspects of life are disrupted by chronic pain. This is a 7 item survey with response options of 0-10. Each item may be assessed individually, or by summing all items. Individual item range of scores: 0-10 Total range of scores: 0-70. The higher the index, the greater the person's disability due to pain.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Absorption is assessed by the Tellegen Absorption Scale
Description
Tellegen Absorption Scale is a 34-item multi-dimensional measure that assesses imaginative involvement and the tendency to become mentally absorbed in everyday activities. Item responses are on a 5-point Likert scale. Items are summed to score. Range of scores: 0-136. Higher scores indicate greater levels of absorption.
Time Frame
Baseline
Title
Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire
Description
Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire (ITQ). This is an 18-item survey. Item responses use a 7 point Likert scale. Subscales include: focus, involvement, emotions, and play. Each subscale is scored by summing items. A total score is scored by summing all items. Range of total score: 18-126 Focus range of scores: 5-35 Involvement range of scores: 5-35 Emotions range of scores: 4-28 Play range of scores: 3-21 Higher scores indicate higher immersive tendencies overall and in each sub-scale.
Time Frame
Baseline
Title
fMRI Imaging
Description
We are studying pain by functional Magnetic Resonance Imaging (fMRI) which allows us to identify certain parts of the brain that show how the brain works in controlling pain perception and cognitions.
Time Frame
Baseline - Final assessment (average 1 week post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zina Trost, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34407034
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.
Results Reference
derived

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Virtual Reality Walking for Neuropathic Pain in Spinal Cord Injury

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