WaveWriterâ„¢ Spinal Cord Stimulator Approved for Treatment of Nonsurgical Back Pain

Feb 22, 2024

Supported by Positive One-Year Results from SOLIS, a Multicenter Trial including WK Spine & Pain Specialists

Positive one year results from a randomized controlled trial at Willis Knighton Health and other sites across the United States have resulted in FDA approval of Boston Scientific’s WaveWriter™ Spinal Cord Stimulator System for the treatment of nonsurgical back pain (NSBP).

John Noles, MD, of WK Spine & Pain Specialists, was principal investigator for the trial at Willis Knighton. Sub-investigators included Drs. David Hirsch, Russell Stuermann and Nancy Germany. Contributions to the study were also made by Bridget Whittington, PA-C; Emily LeBlanc, PA-C; Carmen Schaumberg, PA-C; and Samerrial Williams, FNP-C. Ryan Wilkerson is clinical research coordinator of clinical trials for WK Spine & Pain Specialists.

Spinal cord stimulation has been used for many years to treat patients who continue to have chronic and severe back and leg pain after lumbar spine surgery.   “There are multiple strong studies that have proven the effectiveness of this therapy in patients who have already undergone a surgical procedure,” Dr. Noles said.   

The new indication for nonsurgical back pain expands the use of WaveWriter™ Spinal Cord Stimulator to patients who have had limited options for treating their chronic lower back and leg pain. Results of the trial showed that at the end of one year, 84 percent of patients reported pain relief of 50% or more and a sustained improvement in their ability to participate in activities of daily living after receiving WaveWriter™.

The study was open to patients 18 and older who suffered from chronic back pain and had not undergone surgery. Patients were assigned either to a control group where they received conventional standard of care or to an experimental group where they received spinal cord stimulation. At the end of the three month mark, patients in the control group were able to switch over to using the WaveWriter™ device.

The WaveWriter™ is much like a pacemaker and is programmed to send out mild electrical pulses to specific nerves along the spinal cord to block pain signals before they reach the brain.

Nearly three out of 10 U.S. adults – 72.3 million – currently suffer from pack pain. Patients with chronic back pain usually receive physical therapy and medication when symptoms first begin. However, patients often stop responding to these interventions or suffer side effects and have poor long-term outcomes.

“WK Spine & Pain Specialists is proud to participate in this important study,” Dr. Noles said.  “In collaboration with Boston Scientific and other leading physicians across the country, we are excited to help bring more effective therapies to our patients who are suffering with chronic low back and leg pain.”