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

Area of Science:

• Pain Management
• Epidemiology
• Clinical Trials

Background:

• Transforaminal epidural steroid injections (TESI) are increasingly utilized for sciatica management.
• The safety, effectiveness, and cost-effectiveness of TESI remain subjects of ongoing debate.
• This statistical analysis plan outlines the methodology for the STAR trial, focusing on acute sciatica (less than 8 weeks).

Purpose of the Study:

• To assess the cost-effectiveness of transforaminal epidural steroid injections (TESI) in patients with acute sciatica.
• To compare TESI combined with levobupivacaine and oral pain medication against oral pain medication alone.
• To evaluate TESI with levobupivacaine and saline versus TESI with levobupivacaine and oral pain medication.

Main Methods:

• A multicentre, randomized controlled trial (RCT) involving three comparison groups for acute sciatica due to herniated lumbar disc.
• Co-primary outcomes include physical functioning (Roland Morris Disability Questionnaire), pain intensity (numerical rating scale), and perceived recovery (Likert scale).
• Intention-to-treat analyses using mixed models will be conducted, with secondary outcomes including quality of life (EQ-5D-5L) and patient satisfaction.

Main Results:

• The STAR trial aims to provide definitive statistical analysis for the (cost-)effectiveness of TESI.
• Minimal clinically relevant differences for pain, function, and recovery rates have been pre-defined.
• Economic evaluation will be performed using multivariate imputation and seemingly unrelated regression.

Conclusions:

• This plan details the statistical analysis for the STAR trial.
• The trial will generate evidence on the (cost-)effectiveness of TESI for acute sciatica.
• Findings will inform clinical decision-making regarding TESI in sciatica management.