Virtual Walking for Neuropathic Pain in Spinal Cord Injury

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT01884662
Collaborator
(none)
67
1
2
105.9
0.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual walking
  • Behavioral: Wheeling tape
N/A

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

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Virtual Walking for Reducing Spinal Cord Injury-Related Neuropathic Pain
Actual Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual walking

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.

Behavioral: Virtual walking
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.

Active Comparator: Wheeling tape

A 3D video was produced of legs in a wheelchair covering the identical conditions of the walking experimental video.

Behavioral: Wheeling tape
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
Other Names:
  • A video of a person's legs in a wheelchair traversing a path
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in Numeric Rating Scale [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".

    Secondary Outcome Measures

    1. Changes in fMRI correlates of neuropathic pain [Baseline and immediately post 14 day treatment]

      We will use CASL-fMRI image processing and methods for estimating shifts in cortical somatosensory plasticity

    2. Changes in Pain Interference [Baseline, immediately post 14 day treatment, one week, and one, three and six months post treatment]

      The seven pain interference items of the Brief Pain Inventory

    3. Changes in Neuropathic Pain Scale [Baseline, immediately 14 days post treatment, one week, one, three and six months post treatment]

      An 11 item scale specifically measuring the symptoms of neuropathic pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    -

    Exclusion Criteria: Unable to independently transfer to the fMRI scanning table, current pressures sores, contraindications to scanning; non-compliance with a pre-assignment task.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spain REhabilitation Center Birmingham Alabama United States 35233

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: John S Richards, PhD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John S. Richards, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT01884662
    Other Study ID Numbers:
    • H133N110008VWalking
    First Posted:
    Jun 24, 2013
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by John S. Richards, Principal Investigator, University of Alabama at Birmingham
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 30, 2021