Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury
- Conditions
- Spinal Cord InjuriesNeuropathic Pain
- Interventions
- Other: VR Game 2Other: VR Game 1
- Registration Number
- NCT05005026
- Lead Sponsor
- Texas A&M University
- Brief Summary
The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury.
- Detailed Description
Many people with SCI experience neuropathic pain. Neuropathic pain is often described as sharp, burning, or electric. 'Traditional' treatments often do not do a good job of reducing neuropathic pain. Therefore, it is important to see if 'non-traditional' treatments might work. Scientists think that neuropathic pain occurs in SCI because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. This 'mis-match' may result in changes in the brain that make neuropathic pain possible. Virtual reality walking reduces this 'mis-match.' It does this by creating the 'illusion' that the person is walking. The brain then thinks it is telling the body to walk AND the information coming from the eyes matches its instructions. This 'matching' may reverse the brain changes that made neuropathic pain possible. The current study is specifically focused on individuals whose SCI has been classified as complete (ASIA A).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
The study will recruit individuals with complete injury (American Spinal Injury Association [ASIA] classification A) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:
- Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
- Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
- Must be 18 years of age or older
- Must be more than one year post-injury to begin study (can be screened at an earlier time for eligibility)
- Must have mobile connectivity with usable service
- Must be stable on pain medication for 1 or more months
- Must be cleared on the VRWalk physical activity clearance scale
- Must not have motion sickness that interferes with daily life
- Individuals with Injury levels between C1 and C4
- Individuals under the age of 18
- Individuals who were injured within the past year
- Individuals who cannot comprehend spoken English
- Individuals who are in prison
- Individuals who are blind
- Individuals who experience severe motion sickness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual reality (VR) game 2 VR Game 2 Participants will be asked to play a virtual reality game twice a day for 10 days. Virtual reality (VR) game 1 VR Game 1 Participants will be asked to play a virtual reality game twice a day for 10 days.
- Primary Outcome Measures
Name Time Method Change in Pain Intensity Baseline - final follow up (up to 18 months) The Numeric Rating Scale (NRS) measures pain intensity via 0-10 numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain imaginable.
- Secondary Outcome Measures
Name Time Method Post treatment change at follow up (up to 18 months) The Patient Global Impression of Change is a one item 7 point Likert item assessing improvement of the participants overall status. A score of 1 is 'Very Much Improved', and a score of 7 is 'Very Much Worse.' Higher scores indicate less perceived improvement.
Range of scores: 1-7Change in Pain Interference Baseline - final follow up (up to 18 months) The International Spinal Cord Injury Pain Basic Data Set version 2.0 interference assesses the degree to which pain interferes with day-to-day activities, mood, and sleep. Items are scored on a 0-10 numeric rating scale and scores are summed to yield an interference score ranging from 0 to 30. Higher scores indicate greater interference from pain.
Change in mood Baseline - final follow up (up to 18 months) Mood will be assessed using the Patient Health Questionnaire-9. Participants will be asked to rate how often they have been bothered by specific problems on a 4-point Likert scale, where 0 is 'Not at all,' and 3 is 'Nearly every day.' The items are summed to yield a score ranging from 0-27. Higher scores indicate worse mood.
Change in Pain Quality Baseline - final follow up (up to 18 months) The Neuropathic Pain Scale (NPS) assesses the distinct pain qualities including sharpness, heat/cold, dullness, intensity, overall unpleasantness, and surface vs. deep pain. The NPS consists of 10 items. All the items are rated 0-10 scale, with higher score indicative of more neuropathic pain for each type of respective pain.
Neurological changes Baseline - 6 months For eligible and interested participants, functional Magnetic Resonance Imaging (fMRI) will be used to observe neurological changes. Pre and post-study images will be compared by experienced researchers.
Change in quality of life Baseline - final follow up (up to 18 months) 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 where 1 is 'Strongly disagree,' and 7 is 'Strongly agree'. Items may be assessed individually or by summing items.
Range of scores: 5-35. Higher scores indicate more satisfaction in life
Trial Locations
- Locations (3)
University of New South Wales
🇦🇺Sydney, New South Wales, Australia
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Texas A&M University
🇺🇸College Station, Texas, United States