STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan.

ABSTRACT:

Background

Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks).

Methods

The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (contr

SUBMITTER: Ter Meulen BC 

PROVIDER: S-EPMC7821662 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature