Stroke Programs

Percutaneous Electrical Stimulation for Low Back Pain

General Information on this clinical study

Principal Investigator: Daniel Malkamaki, M.D.

Clinical Coordinator: Cathy Corrigan, R.N.

Contact Number: 216-778-8903

Contact Email: ccorrigan@metrohealth.org

Program Title: Percutaneous Electrical Stimulation for Low Back Pain

Purpose

The study will investigate the safety and effectiveness of percutaneous electrical stimulation (PENS) to treat chronic low back pain. In this study, temporary percutaneous electrodes are inserted through the skin and embedded into deep tissue. Percutaneous electrical stimulation to treat low back pain is experimental and the United States Food and Drug Administration has approved it for investigational use only.

Program Description

The study is a pilot study which will enroll 10 adults with stable, moderate to severe, chronic low back pain of nonspecific (muscle sprain/strain, etc.) or discogenic origin. The subjects will receive percutaneous stimulation delivered by a set of temporary implanted wire electrodes in the low back region. They will receive 6-hours of stimulation per day for 6 weeks and will be followed for 6 months. Outcome measures will include: pain intensity/interference, back-pain-specific disability, and quality of life measures. This study is currently enrolling subjects.