search
Back to results

Virtual Walking for Neuropathic Pain in Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual walking
Wheeling tape
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, neuropathic pain

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Spain REhabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual walking

Wheeling tape

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Changes in fMRI correlates of neuropathic pain
We will use CASL-fMRI image processing and methods for estimating shifts in cortical somatosensory plasticity
Changes in Pain Interference
The seven pain interference items of the Brief Pain Inventory
Changes in Neuropathic Pain Scale
An 11 item scale specifically measuring the symptoms of neuropathic pain.

Full Information

First Posted
September 11, 2012
Last Updated
August 26, 2021
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT01884662
Brief Title
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
Official Title
Virtual Walking for Reducing Spinal Cord Injury-Related Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Neuropathic Pain
Keywords
spinal cord injury, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual walking
Arm Type
Experimental
Arm Description
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.
Arm Title
Wheeling tape
Arm Type
Active Comparator
Arm Description
A 3D video was produced of legs in a wheelchair covering the identical conditions of the walking experimental video.
Intervention Type
Behavioral
Intervention Name(s)
Virtual walking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wheeling tape
Other Intervention Name(s)
A video of a person's legs in a wheelchair traversing a path
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Numeric Rating Scale
Description
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".
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
Secondary Outcome Measure Information:
Title
Changes in fMRI correlates of neuropathic pain
Description
We will use CASL-fMRI image processing and methods for estimating shifts in cortical somatosensory plasticity
Time Frame
Baseline and immediately post 14 day treatment
Title
Changes in Pain Interference
Description
The seven pain interference items of the Brief Pain Inventory
Time Frame
Baseline, immediately post 14 day treatment, one week, and one, three and six months post treatment
Title
Changes in Neuropathic Pain Scale
Description
An 11 item scale specifically measuring the symptoms of neuropathic pain.
Time Frame
Baseline, immediately 14 days post treatment, one week, one, three and six months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Richards, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spain REhabilitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30407030
Citation
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.
Results Reference
derived

Learn more about this trial

Virtual Walking for Neuropathic Pain in Spinal Cord Injury

We'll reach out to this number within 24 hrs