Skip to main content
OpenTrials
Completed

NCT Number: NCT01884662

Virtual Walking for Neuropathic Pain in Spinal Cord Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spain REhabilitation Center

Birmingham, Alabama, 35233, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Virtual walking

Behavioral

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 tape

Behavioral

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

Primary outcomes

  1. 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".

Secondary outcomes

  1. Changes in fMRI correlates of neuropathic pain

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Virtual Walking for Reducing Spinal Cord Injury-Related Neuropathic Pain

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2013
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.