High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial.

ABSTRACT:

Background

Spinal cord stimulation (SCS) has been shown to provide pain relief for chronic back and leg pain due to failed back surgery syndrome. But many patients with chronic back pain have not had major back surgery or are not good candidates for surgery, and conventional medical management (CMM) provides limited relief. We have termed this condition nonsurgical refractory back pain (NSRBP). Level 1 evidence does not yet exist showing the therapeutic benefit of SCS for NSRBP.

Objective

To compare 10-kHz SCS plus CMM (10-kHz SCS + CMM) to CMM alone for treatment of NSRBP in terms of clinical and cost effectiveness.

Study design

Multicenter, randomized controlled trial (RCT), with subjects randomized 1:1 to either 10-kHz SCS + CMM or CMM alone. Optional crossover occ

SUBMITTER: Patel N 

PROVIDER: S-EPMC7891432 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature