Treatment of Chronic Abdominal Pain With 10-kHz Spinal Cord Stimulation: Safety and Efficacy Results From a 12-Month Prospective, Multicenter, Feasibility Study.
(Clinical Trial;Journal Article;Multicenter Study)
INTRODUCTION: Chronic abdominal pain (CAP) can arise from multiple conditions, including inflammatory disorders, trauma because of injury or surgery, or structural or functional causes. This prospective, single-arm study was designed to evaluate the safety and efficacy of 10-kHz spinal cord stimulation (SCS) in patients with intractable CAP over a 12-month follow-up period. METHODS: Subjects with CAP who had been refractory to conventional medical treatment for at least 3 months resulting in self-reported pain scores of ≥5 cm on a 10-cm visual analog scale were enrolled at 4 centers in the United States. Study subjects underwent a trial stimulation lasting up to 14 days with epidural leads implanted from the vertebral levels T4 through T8. Subjects who had ≥40% pain relief during the trial stimulation period were implanted with a Senza system (Nevro Corp., Redwood City, CA) and followed up to 12 months after surgery. RESULTS: Twenty-three of 24 subjects (95.8%) had a successful trial stimulation and proceeded to a permanent implant. After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ≥50%) and 14 of 22 subjects (63.6%) were remitters (sustained ≤3.0-cm visual analog scale scores). Secondary outcomes, including assessments of disability, mental and physical well-being, sleep quality, perception of improvement, and satisfaction, showed that 10-kHz SCS greatly improved the quality of life of patients with CAP. Observationally, most subjects also reported concurrent reduction or resolution of nausea and/or vomiting. DISCUSSION: 10-kHz SCS can provide durable pain relief and improve the quality of life in patients with CAP.
Kapural, L; Gupta, M; Paicius, R; Strodtbeck, W; Vorenkamp, KE; Gilmore, C; Gliner, B; Rotte, A; Subbaroyan, J; Province-Azalde, R
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