PRECISE--pregabalin in addition to usual care: statistical analysis plan.

Area of Science:

• Clinical Trials Methodology
• Pain Management Research
• Pharmacoeconomics

Background:

• Sciatica is a debilitating condition with limited high-quality evidence for effective treatments.
• The PRECISE study addresses the need for robust evidence on sciatica management strategies.

Purpose of the Study:

• To determine the efficacy and cost-effectiveness of pregabalin versus placebo for sciatica.
• To evaluate pregabalin's impact on leg pain intensity, disability, back pain, quality of life, and work absenteeism.

Main Methods:

• A prospectively registered, double-blind, randomized placebo-controlled trial (PRECISE study).
• Intention-to-treat principle with repeated-measure linear mixed models for primary and secondary outcomes over 52 weeks.
• Statistical significance set at p < 0.05, with subgroup analysis for neuropathic pain features.

Main Results:

• Analysis will compare pregabalin and placebo groups on leg pain intensity, disability, and other outcomes.
• Serious adverse events and adverse events will be reported and compared between groups.
• Economic evaluation planned if a significant treatment effect is observed at week 8.

Conclusions:

• The PRECISE study's statistical analysis plan details the methodology for generating evidence on sciatica management.
• Findings will inform effective and affordable treatment strategies for sciatica patients.