Treatment of Chronic Abdominal Pain With 10-kHz Spinal Cord Stimulation: Safety and Efficacy Results From a 12-Month Prospective, Multicenter, Feasibility 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.