Boston Scientific’s Spinal Cord Stimulation Systems Effective at Reducing Back Pain

Using the WaveWriter and WaveWriter Alpha Spinal Cord Stimulation (SCS) Systems (Boston Scientific, Marlborough, MA) resulted in sustained pain relief as treatment for non-surgical back pain (NSBP), according to positive 1-year results from the SOLIS clinical trial (NCT04676022). These findings were presented at the 2024 Annual Meeting of the North American Neuromodulation Society (NANS).

SOLIS is an ongoing, randomized controlled study to evaluate the safety and effectiveness of the WaveWriter Systems in adults aged ≥22 years who have low back pain and who have received ≥90 days of documented pain management care prior to screening. Participants were randomized to receive either SCS therapy with the WaveWriter Systems or conventional medical management (CMM) for their low back NSBP.

According to the presented results:

• At the primary endpoint interval of 3 months postactivation, 90% of the participants (N=128) who received SCS treatment reported significant pain relief of ≥50% without an increase in opioids. Only 8% of participants receiving CMM reported pain relief of ≥50% (P=.0001).
• At 1 year, 84% of the randomized participants reported significant relief in pain of ≥50%, along with a mean 25point improvement in Oswestry Disability Index (ODI) score, indicating sustained improvements in their ability to participate in activities of daily living. 

At the 1-year interval, participants who were randomized to receive CMM were permitted to switch to SCS therapy. Of these crossover participants, 85% reported a ≥50% reduction in pain and a mean improvement of 30-points in ODI score, demonstrating significant improvement in pain and disability consistent with the participants who were initially randomized to receive SCS.

“Continued positive results from the SOLIS study illustrate the need for early and effective pain treatment when just the standard of care is not enough,” said Jim Cassidy, President of Neuromodulation at Boston Scientific. “Backed by consistently strong clinical evidence, our transformative pain management solutions help individualize care and improve the quality of life for the many people living with chronic pain today.”

                                                    Image of the WaveWriter SCS Systems.