Conflict of Interest: Timothy Deer, MD, has received consulting fees from Medtronic Inc., St. Jude Medical, Spinal Modulation, Bioness, and Vertos Medical. He is an advisory board member for Spinal Modulation and Vertos Medical. He has received research funding from Bioness, St. Jude Medical, Vertos, Spinal Modulation, and Medtronic.
Editor’s Choice: Prospective Nonrandomized Trial
A Prospective Study of Dorsal Root Ganglion Stimulation for the Relief of Chronic Pain
Article first published online: 14 DEC 2012
© 2012 International Neuromodulation Society
Neuromodulation: Technology at the Neural Interface
Volume 16, Issue 1, pages 67–72, January/February 2013
How to Cite
2012. A Prospective Study of Dorsal Root Ganglion Stimulation for the Relief of Chronic Pain.Neuromodulation 2012; e-pub ahead of print. DOI: 10.1111/ner.12013, , , ,
Eric Grigsby, MD, has received fees for serving as a speaker, a consultant, and an advisory board member for Azur Pharmaceuticals, Medtronic, Inc., St. Jude Medical, Spinal Modulation, Vertos and Xalud, and has received research funding from Alfred Mann Foundation, Medtronic, Inc., Spinal Modulation, Spinal Restoration, St. Jude Medical, Vertos. He is an employee of Neurovations and Napa Pain Institute, and owns stocks and shares in Spinal Modulation, Spinal Restoration, Vertos, and Xalud.
Jeffery Kramer, PhD, is an employee of Spinal Modulation.
Richard Weiner, MD, is a consultant and shareholder for Spinal Modulation.
Bernard Wilcosky, MD, has nothing to disclose.
For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/bw/submit.asp?ref=1094-7159&site=1
- Issue published online: 1 FEB 2013
- Article first published online: 14 DEC 2012
- Manuscript Accepted: 10 OCT 2012
- Manuscript Revised: 14 SEP 2012
- Manuscript Received: 20 MAR 2012
- Alfred Mann Foundation
- Spinal Modulation, Inc
- Dorsal root ganglion;
- chronic pain;
The article aims to study the safety and effectiveness of dorsal root ganglion (DRG) stimulation with a new device in the treatment of chronic pain.
This is a prospective, single-arm, pilot study.
Four clinical centers were used as setting for this study.
Ten (10) patients with chronic intractable pain of the trunk and/or limbs were included.
A trial period of DRG stimulation was studied. Two to four leads, each with four electrical contacts, were inserted using a minimally invasive epidural approach and steered toward the lateral epidural space, near the DRG. Leads were attached to an external trial stimulator and stimulation therapy was provided for three to seven days.
Pain reduction using a visual analog scale, subject and physician-rated improvement, adverse event (AE) rates, device programming settings, and medication utilization was evaluated at baseline and at prospective follow-up time points during stimulation.
On average, there was a 70% reduction in pain following stimulation (p = 0.0007). Eight of the nine patients experienced a clinically meaningful (>30%) reduction in pain, and seven of the nine reduced their pain medication utilization. Pain relief in specific anatomical regions such as the leg, back, and foot was also observed. No device-related AEs were reported.
These initial results suggest that stimulation of the DRG can reduce pain in those patients suffering from chronic pain. DRG stimulation may offer several potential benefits over other neuromodulation techniques, including the ability to target difficult-to-reach anatomies such as the low back and foot.