Spinal Cord InjuriesNCT03735017
Virtual Reality Walking for Neuropathic Pain in Spinal Cord Injury
A study testing Non-Interactive Virtual Reality Walking and Interactive Virtual Reality Walking in people with Spinal Cord Injuries and Neuropathic Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will examine the effectiveness of one of two virtual reality treatments on neuropathic pain in individuals with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- Non-Interactive Virtual Reality Walking and Interactive Virtual Reality Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2018to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
This study will examine the effectiveness of one of two virtual reality treatments on neuropathic pain in individuals with spinal cord injury.
Read the 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.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- Non-Interactive Virtual Reality Walking, Interactive Virtual Reality Walking
- Keywords
- Virtual Reality
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interactive Virtual Reality WalkingOther
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 Virtual Reality WalkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Interactive | Active comparator | Participants will receive non-interactive virtual reality walking sessions. Receives: Other: Non-Interactive Virtual Reality Walking |
| Interactive | Experimental | Participants will receive interactive virtual reality walking sessions. Receives: Other: Interactive Virtual Reality Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
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
Measured: Final assessment (average 1 week post treatment)
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
Measured: Final assessment (average 1 week post treatment)
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.
Measured: Final assessment (average 1 week post 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.
Measured: Final assessment (average 1 week post treatment)
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.
Measured: Baseline - Final assessment (average 1 week post treatment)
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
Measured: Baseline - Final assessment (average 1 week post treatment)
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.
Measured: Baseline - Final assessment (average 1 week post treatment)
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.
Measured: Baseline - Final assessment (average 1 week post treatment)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline - Final assessment (average 1 week post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start16 Jun 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zina Trost, University of Alabama at Birmingham
- Investigators
- Zina Trost, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735017
- Sponsor's protocol ID
- 383546
- Status last verified
- Nov 2021
- First submitted
- 31 Oct 2018
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34407034
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03735017
- Acronym / sponsor ID
- 383546
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 16 Jun 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Interactive | Active comparator | Other: Non-Interactive Virtual Reality WalkingParticipants will receive non-interactive virtual reality walking sessions. |
| Interactive | Experimental | Other: Interactive Virtual Reality WalkingParticipants will receive interactive virtual reality walking sessions. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interactive Virtual Reality WalkingIndividuals 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. | Other | Non-Interactive |
| Interactive Virtual Reality WalkingIndividuals 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. | Other | Interactive |
Primary outcome
Pain Intensity as assessed by Numeric Rating Scale
Time frame: Baseline - Final assessment (average 1 week post treatment)
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
Time frame: Baseline - Final assessment (average 1 week post treatment)
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
Time frame: Baseline - Final assessment (average 1 week post treatment)
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
Time frame: Baseline - Final assessment (average 1 week post treatment)
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
Time frame: Baseline - Final assessment (average 1 week post treatment)
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.
11 secondary outcomes
Patient Treatment Evaluation as assessed by the Ease of Usefulness, Satisfaction, and Ease of Use Questionnaire
Time frame: Final assessment (average 1 week post treatment)
Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
Time frame: Final assessment (average 1 week post treatment)
Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
Time frame: Final assessment (average 1 week post treatment)
Patient Treatment Evaluation as assessed by Semi-structured Qualitative Interviewing
Time frame: Final assessment (average 1 week post treatment)
Quality of Life and Participation are assessed by the SF-36 Walk-Wheel
Time frame: Baseline - Final assessment (average 1 week post treatment)
Quality of Life is assessed by Satisfaction with Life Scale
Time frame: Baseline - Final assessment (average 1 week post treatment)
Depression and mood are assessed by the Patient Health Questionnaire -9
Time frame: Baseline - Final assessment (average 1 week post treatment)
Perceived Disability is assessed by the Pain Disability Index
Time frame: Baseline - Final assessment (average 1 week post treatment)
Absorption is assessed by the Tellegen Absorption Scale
Time frame: Baseline
Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire
Time frame: Baseline
fMRI Imaging
Time frame: Baseline - Final assessment (average 1 week post treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 34407034Trost 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zina Trost, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Interactive Virtual Reality Walking and Interactive Virtual Reality Walking in people with Spinal Cord Injuries and Neuropathic Pain, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity as assessed by Numeric Rating Scale (time frame: Baseline - Final assessment (average 1 week post treatment)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03735017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.