Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury
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.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- The study will recruit individuals with complete injury (American Spinal Injury Association [ASIA] classification A) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury.
- 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.
Exclusion criteria
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT05005026
Intervention or treatment
OTHER: VR Game 1
OTHER: VR Game 2
Conditions
- Spinal Cord Injuries
- Neuropathic Pain
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
University of New South Wales
Select from list below to view details:
University of New South Wales
Sydney, New South Wales, Australia
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Who is running the clinical trial?
Texas A&M University
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Virtual reality (VR) game 1
| Other: VR Game 1 |
ACTIVE_COMPARATOR: Virtual reality (VR) game 2
| Other: VR Game 2 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | 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. | Baseline - final follow up (up to 18 months) |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Quality | 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. | Baseline - final follow up (up to 18 months) |
| Change in Pain Interference | 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. | Baseline - final follow up (up to 18 months) |
| Post treatment change | 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: 1-7 | at follow up (up to 18 months) |
| Change in mood | 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. | Baseline - final follow up (up to 18 months) |
| Change in quality of life | 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 | Baseline - final follow up (up to 18 months) |
| Neurological changes | 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. | Baseline - 6 months |
References
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