Pressure Sore Prevention & Treatment

Utilizing electrical stimulation, participants can condition muscles and tissue to facilitate pressure sore prevention.

General Information on this clinical study

Principal Investigators: Kath Bogie, D. Phil and Chester Ho, M.D.

Clinical Coordinator: Pat Banks, R.N.

Contact Number: 216-791-3800 ext. 4131

Contact Email: patricia.banks@med.va.gov

Program Title: Pressure Sore Prevention & Treatment

Purpose

This program explores utilizing percutaneous electrical stimulation to prevent the occurence of pressure sores in individuals with a spinal cord injury.

Program Description

The purpose of this study is to investigate new techniques for addressing the underlying causes of pressure sores. Neuromuscular electrical stimulation (NMES) can change the characteristics of paralyzed muscles to improve their long-term response to loading, especially while seated in a wheelchair.

The objectives of this study are two-fold: first, to determine the effects of exercise with NMES on the tissue viability of the skin and underlying muscle most susceptible to pressure sores, thus altering the intrinsic properties of the tissue that contribute to decubitus ulcers, and second, to determine the efficacy of using NMES to vary the pressure distribution under the buttocks dynamically while sitting, addressing the primary extrinsic factor in pressure sore formation.

A total of 30 volunteers with spinal cord injuries stratified into two interventions and one control group will be recruited. The intervention groups will receive varying doses of exercise and dynamic weight shifting with NMES. Stimulation will be applied bilaterally to the gluteal muscles via chronically indwelling intramuscular electrodes with percutaneous leads. Subjects in one group will undergo an intensive exercise program with NMES followed by dynamic weight shifting, while volunteers in the second group will proceed directly to dynamic weight shifting in their wheelchairs without the preparatory exercise program. Progressive changes in muscle bulk and blood flow will be monitored using computerized tomography (CT) and transcutaneous oxygen measurement. Changes in weight distribution both over the long-term (due to alterations in the intrinsic muscle properties) and over the short-term (due to active muscle contractions) will be assessed using interface pressure measurements. The location and magnitude of high pressure regions will be monitored to determine the effectiveness of dynamic posture shifting produced by alternating the stimulation to the left and right gluteal muscles. Finally, NMES will be withdrawn so that progressive changes after long-term use of NMES can be monitored. The third group will consist of individuals with chronic SCI who will provide baseline data on pressure distributions, muscle bulk and transcutaneous tissue oxygen for the population. Four individuals are currently participating in the study. One individual is participating as control subject. Three individuals have received gluteal stimulation systems and results to date indicate sustained improvement of tissue health with regular use of NMES.