ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol).

ABSTRACT:

Introduction

Chronic low back pain (CLBP) is the leading cause of years lived with disability globally. The role of restorative neurostimulation in the treatment of patients with refractory mechanical CLBP and multifidus muscle dysfunction has been established in one randomized controlled trial (RCT) and several clinical studies that demonstrated both safety and clinical benefit. This post-market trial provides a direct comparison to optimized medical management to test the hypothesis that the addition of restorative neurostimulation to current care paradigms results in significant improvements in back pain-related disability.

Methods and analysis

This trial will include people who have reported significant levels of back pain and back pain-related disability with symptoms t

SUBMITTER: Gilligan C 

PROVIDER: S-EPMC10036695 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature