A Prospective, Multi-Center, Clinical Trial of a 10-kHz Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain.

ABSTRACT:

Background

Chronic pelvic pain (CPP) is a debilitating condition that often leads to disability and does not respond to conventional treatments. This study was conducted to evaluate the effects of paresthesia-independent 10-kHz spinal cord stimulation (SCS) in subjects with CPP.

Methods

This prospective, single-arm pilot study enrolled subjects with clinical diagnoses of CPP and mean pain scores of ≥ 5.0 cm on a 10-cm VAS. Subjects underwent trial stimulations with 10-kHz SCS, and those who had successful trial stimulations (≥40% pain relief) received permanently implanted devices and were followed for 12 months.

Results

Of the 21 subjects who underwent the 10-kHz SCS trial, 17 were successful and 14 subjects received permanent implants. No neurological deficits were

SUBMITTER: Tate JL 

PROVIDER: S-EPMC7818476 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature