Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial.

ABSTRACT:

Introduction

Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment.

Methods and analysis

This is a parallel gro

SUBMITTER: Koetsier E 

PROVIDER: S-EPMC8968527 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature