Topical pain relief cream formulation in the management of knee osteoarthritis: a randomized, double-blind and placebo-controlled clinical study

Vollständiger Abstract

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Background: Topical formulations provide localized pain relief with improved safety profile. This study evaluated the efficacy and safety of a topical pain relief cream formulation in subjects with knee OA compared with placebo. Methods: This multicentric, randomized, double-blind, placebo-controlled clinical study analyzed 335 subjects with clinically diagnosed knee OA who received either a topical pain relief cream formulation (Group B, n=166) or placebo (Group A, n=169) for 28 days. Primary efficacy endpoints were knee joint pain assessed using visual analog scale (VAS) and joint swelling. Secondary endpoints included modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, knee joint tenderness, warmth, onset and duration of action, global assessments, and safety. Results: The topical pain relief cream formulation demonstrated significantly greater reductions in knee joint pain (19.7-21.4% at day 14 and 38.3-38.6% at day 28, p