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  • Low Back Pain Relief With a New 32-Contact Surgical Lead and Neural Targeting Algorithm

    Final Number:

    Julie G. Pilitsis MD, PhD; Giancarlo Barolat MD; Joshua M. Rosenow MD FAANS FACS; James J. Brennan MD; Alexander S Bailey MD; Jeffrey M. Epstein MD; Blake Hammond P.A.; Clark Metzger M.D.; Dat Huynh Ph.D.; Kristen Lechleiter M.S.; Nitzan Mekel-Bobrov PhD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2016 Annual Meeting

    Introduction: Treatment of low-back pain using Spinal Cord Stimulation (SCS) has been historically challenging. Advances in surgical leads and programming capabilities have been thought to potentially enable improved low-back pain relief using SCS. A recently introduced 32-contact surgical lead, which couples multiple independent current control (MICC) and anatomically-based neural targeting stimulation algorithms, allows for patient-specific programming optimization. We present here a real world, observational study of this 32-contact surgical lead.

    Methods: A multi-center, consecutive, observational study of a new 32-contact surgical lead was carried out using the Precision Spectra SCS System (Boston Scientific) in 100 subjects out to 12 months post-implant. We examine medical history, procedural information, programming parameters, and clinical outcomes including pain reduction (NRS), activities of daily living, and change in pain medications.

    Results: Surgical lead placement distribution was between T7 and L2, with most at T9 (26%). A mean reduction of 5.1 points (SD 2.15, p<0.001) from 7.8 (baseline) to 2.6 in overall pain was observed. A subset of subjects reporting low-back pain only exhibited a mean decrease of 6.0 points (SD 2.12, p<0.001) from 8.3 (baseline) to 2.2. Of these, 83.1% percent of subjects showed =50% back pain reduction. Increases in activities of daily living and reduction in pain medication usage were also observed in a majority of subjects.

    Conclusions: Subjects implanted with a 32-contact surgical lead using a neural targeting algorithm demonstrated significant low-back pain reduction. These results support the postulate that advanced surgical leads and programming capabilities can foster improved low-back pain relief in subjects treated using SCS.

    Patient Care: By enabling more options and capabilities for patients, this can help facilitate more personalized SCS therapy that can be customized to the individual patient.

    Learning Objectives: To collect real world evidence of low back pain relief outcomes using a new 32-contact surgical lead and a system that uses unique programming algorithms that can achieve highly customized, patient-specific stimulation settings capable of robust and specific neural targeting.


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