Spinal Cord InjuryNCT01884662
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
A study testing Virtual walking and Wheeling tape in people with Spinal Cord Injury and Neuropathic Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of the most problematic of secondary conditions that is minimally to modestly responsive to currently available treatments. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Neuropathic Pain
- What is being tested?
- Virtual walking and Wheeling tape
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 30 Jun 2021
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: traumatic onset SCI, at least three months post onset, between 19 and 65; at least 6th grade reading level; neuropathic pain averaging at least 4/10.
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Exclusion Criteria: Unable to independently transfer to the fMRI scanning table, current pressures sores, contraindications to scanning; non-compliance with a pre-assignment task.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Spain REhabilitation Center
Birmingham, Alabama, 35233
About this study
Official title: Virtual Walking for Reducing Spinal Cord Injury-Related Neuropathic Pain
Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of the most problematic of secondary conditions that is minimally to modestly responsive to currently available treatments. It is usually described as burning or stabbing, and is located at or below the level at which their sensation changes from normal to impaired; persons with no feeling at all in their legs for example can experience pain in the legs. The purpose of this project is to further investigate the use of a novel visual stimulation treatment; a technique that has shown benefit in other populations with chronic pain secondary to deafferentation. To accomplish this, a novel treatment - virtual reality (VR) walking - will be examined. Should this treatment show benefit, a portable, accessible means of treatment will be available for persons with SCI and for whom transportation to health care providers is often difficult.
Read the detailed description
This treatment will be investigated in two-phase project:
Phase 1: Determine the efficacy of VR treatments as a home-based approach and determine the effect of VR treatment on reversal of maladaptive cortical reorganization associated with SCI-NP, as has been shown in other populations with neuropathic pain secondary to deafferentation.
Phase 2: Determine the effectiveness and immediate analgesic effect of VR treatment among persons with both tetraplegia and paraplegia.
The primary outcome variable of this research is the severity of SCI-NP with a secondary outcome of level of pain interference with daily activities.
In the phantom pain literature for persons with amputations, treatment paradigms based on visual stimulation, called mirror therapies, have proven helpful. These approaches involve the person viewing a mirror image of their intact limb to produce the visual illusion of a return of the missing limb, often with a marked reduction in pain following. Investigations have demonstrated that such approaches reduce pain in some individuals and that this change is associated with reversal of the functional reorganization in the somatosensory cortex. There has been one study of neuropathic pain in SCI that demonstrated good neuropathic pain relief with a mirror image of the upper half of the individual with SCI with the lower half of their body represented by a rear projection screen generated image of walking legs. We have collaborated with this author, and developed and pilot tested a virtual walking DVD that is presented via virtual reality goggles to enhance the first person sense of immersion. Results were sufficiently encouraging to cause us to seek funding for current, broader project
- Conditions
- Spinal Cord Injury, Neuropathic Pain
- Being tested
- Virtual walking, Wheeling tape
- Keywords
- spinal cord injury, neuropathic pain
- 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.
Virtual walkingBehavioural
As in mirror therapy for amputee phantom pain, there is evidence that neuropathic SCI pain responds to images of the person with SCI's legs "walking"; we achieve this via a virtual reality approach where the subject perceives it is his/her legs walking.
Wheeling tapeBehavioural
Also called A video of a person's legs in a wheelchair traversing a path
This control condition mirrors the experimental condition in all respects except it shows still legs in a wheelchair traversing the same path as the virtual walking condition
| Study group | Role | What they receive |
|---|---|---|
| Virtual walking | Experimental | A 3D video of legs walking from a first person perspective have been developed in consultation with persons with SCI and virtual reality experts. Participants are provided with a 3D monitor and Blue Ray player for daily viewing of the tape for two weeks. Receives: Behavioral: Virtual walking |
| Wheeling tape | Active comparator | A 3D video was produced of legs in a wheelchair covering the identical conditions of the walking experimental video. Receives: Behavioral: Wheeling tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Numeric Rating Scale
The NRS is the most commonly used pain rating scale, and ranges from 0/10 to 10/10 with 10 representing unbearable or the "worst possible pain".
Measured: Baseline, post 14 day treatment, one week, one month, three months, 6 months post 14 day treatment. Changes in the NRS scale will be the outcome
Secondary outcomes (3)
Changes in fMRI correlates of neuropathic pain
We will use CASL-fMRI image processing and methods for estimating shifts in cortical somatosensory plasticity
Measured: Baseline and immediately post 14 day treatment
Changes in Pain Interference
The seven pain interference items of the Brief Pain Inventory
Measured: Baseline, immediately post 14 day treatment, one week, and one, three and six months post treatment
Changes in Neuropathic Pain Scale
An 11 item scale specifically measuring the symptoms of neuropathic pain.
Measured: Baseline, immediately 14 days post treatment, one week, one, three and six months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startSep 2012
- Primary completion30 Apr 2021
- Study completion30 Jun 2021
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 InjuryStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John S. Richards, University of Alabama at Birmingham
- Investigators
- John S Richards, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884662
- Sponsor's protocol ID
- H133N110008VWalking
- Status last verified
- Aug 2021
- First submitted
- 11 Sep 2012
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Richardson EJ, McKinley EC, Rahman AKMF, Klebine P, Redden DT, Richards JS. Effects of virtual walking on spinal cord injury-related neuropathic pain: A randomized, controlled trial. Rehabil Psychol. 2019 Feb;64(1):13-24. doi: 10.1037/rep0000246. Epub 2018 Nov 8.
PubMed 30407030
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Walking for Reducing Spinal Cord Injury-Related Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01884662
- Acronym / sponsor ID
- H133N110008VWalking
- Conditions
- Spinal Cord Injury, Neuropathic Pain
- Keywords
- spinal cord injury, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Jun 2013 (estimated)
- 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.
Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of the most problematic of secondary conditions that is minimally to modestly responsive to currently available treatments. It is usually described as burning or stabbing, and is located at or below the level at which their sensation changes from normal to impaired; persons with no feeling at all in their legs for example can experience pain in the legs. The purpose of this project is to further investigate the use of a novel visual stimulation treatment; a technique that has shown benefit in other populations with chronic pain secondary to deafferentation. To accomplish this, a novel treatment - virtual reality (VR) walking - will be examined. Should this treatment show benefit, a portable, accessible means of treatment will be available for persons with SCI and for whom transportation to health care providers is often difficult.
Detailed description
This treatment will be investigated in two-phase project:
Phase 1: Determine the efficacy of VR treatments as a home-based approach and determine the effect of VR treatment on reversal of maladaptive cortical reorganization associated with SCI-NP, as has been shown in other populations with neuropathic pain secondary to deafferentation.
Phase 2: Determine the effectiveness and immediate analgesic effect of VR treatment among persons with both tetraplegia and paraplegia.
The primary outcome variable of this research is the severity of SCI-NP with a secondary outcome of level of pain interference with daily activities.
In the phantom pain literature for persons with amputations, treatment paradigms based on visual stimulation, called mirror therapies, have proven helpful. These approaches involve the person viewing a mirror image of their intact limb to produce the visual illusion of a return of the missing limb, often with a marked reduction in pain following. Investigations have demonstrated that such approaches reduce pain in some individuals and that this change is associated with reversal of the functional reorganization in the somatosensory cortex. There has been one study of neuropathic pain in SCI that demonstrated good neuropathic pain relief with a mirror image of the upper half of the individual with SCI with the lower half of their body represented by a rear projection screen generated image of walking legs. We have collaborated with this author, and developed and pilot tested a virtual walking DVD that is presented via virtual reality goggles to enhance the first person sense of immersion. Results were sufficiently encouraging to cause us to seek funding for current, broader project
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual walking | Experimental | Behavioral: Virtual walkingA 3D video of legs walking from a first person perspective have been developed in consultation with persons with SCI and virtual reality experts. Participants are provided with a 3D monitor and Blue Ray player for daily viewing of the tape for two weeks. |
| Wheeling tape | Active comparator | Behavioral: Wheeling tapeA 3D video was produced of legs in a wheelchair covering the identical conditions of the walking experimental video. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Virtual walkingAs in mirror therapy for amputee phantom pain, there is evidence that neuropathic SCI pain responds to images of the person with SCI's legs "walking"; we achieve this via a virtual reality approach where the subject perceives it is his/her legs walking. | Behavioural | Virtual walking |
| Wheeling tapeAlso: A video of a person's legs in a wheelchair traversing a pathThis control condition mirrors the experimental condition in all respects except it shows still legs in a wheelchair traversing the same path as the virtual walking condition | Behavioural | Wheeling tape |
Primary outcome
Changes in Numeric Rating Scale
Time frame: Baseline, post 14 day treatment, one week, one month, three months, 6 months post 14 day treatment. Changes in the NRS scale will be the outcome
The NRS is the most commonly used pain rating scale, and ranges from 0/10 to 10/10 with 10 representing unbearable or the "worst possible pain".
3 secondary outcomes
Changes in fMRI correlates of neuropathic pain
Time frame: Baseline and immediately post 14 day treatment
Changes in Pain Interference
Time frame: Baseline, immediately post 14 day treatment, one week, and one, three and six months post treatment
Changes in Neuropathic Pain Scale
Time frame: Baseline, immediately 14 days post treatment, one week, one, three and six months 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 30 Aug 2021.
- Derived from this study: PubMed 30407030Richardson EJ, McKinley EC, Rahman AKMF, Klebine P, Redden DT, Richards JS. Effects of virtual walking on spinal cord injury-related neuropathic pain: A randomized, controlled trial. Rehabil Psychol. 2019 Feb;64(1):13-24. doi: 10.1037/rep0000246. Epub 2018 Nov 8.
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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.
John S Richards, 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 Virtual walking and Wheeling tape in people with Spinal Cord Injury 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?
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 30 Aug 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?
Changes in Numeric Rating Scale (time frame: Baseline, post 14 day treatment, one week, one month, three months, 6 months post 14 day treatment. Changes in the NRS scale will be the outcome). 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 NCT01884662, 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 30 Aug 2021.