• Neuromodulation · Jul 2013

    Multicenter Study Clinical Trial

    Novel spinal cord stimulation parameters in patients with predominant back pain.

    • Jeffrey Tiede, Lora Brown, Gennady Gekht, Ricardo Vallejo, Thomas Yearwood, and Donna Morgan.
    • Dwight D. Eisenhower Army Medical Center, Ft. Gordon, GA, USA.
    • Neuromodulation. 2013 Jul 1;16(4):370-5.

    ObjectivesTo examine the feasibility of novel high-frequency spinal cord stimulation therapy in a cohort of patients with chronic predominant back pain during a four day, percutaneous trial.DesignProspective, multicenter open label pilot trial.Setting And Patients Twenty-four patients with back pain greater than leg pain who were candidates for spinal cord stimulation were trialed at five U.S. centers.InterventionsPatients completed a percutaneous trial with a commercially available spinal cord stimulator. The implanted leads were then connected to the novel external stimulation device and patients were trialed for an additional four days.Outcome MeasuresPain intensity ratings, subjective descriptions, and patients' preference.ResultsThere was significant improvement from baseline in overall pain scores (8.68 to 2.03, [p < 0.001]) and back pain scores (8.12 to 1.88, [p < 0.001]) with the investigational stimulation. The investigational stimulation was preferred to the commercially available systems in 21 of 24 patients (88%).ConclusionsPatients with predominant back pain reported a substantial reduction in overall pain and back pain when trialed with high-frequency spinal cord stimulation therapy.© 2013 International Neuromodulation Society.

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