Concordance of baseline pain measures (across two reporting instruments) influences treatment effect: post hoc analysis of a phase 3 randomized controlled trial of triamcinolone acetonide extended-release in patients with knee osteoarthritis

Abstract

Purpose: In a Phase 3 randomized controlled study, differing efficacy Results were observed when triamcinolone acetonide extended-release (TA-ER) was compared to conventional TA crystalline suspension (TAcs) with two different pain measures, average daily pain (ADP) using a 0-10 numeric rating scale (NRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A subscale). Trial enrollment criteria may have contributed to this discrepancy, as a moderate-to-severe ADP score of ≥5 to ≤9 was required at baseline whereas no limitations were placed on baseline WOMAC-A score (0-4 Likert).