Publication:

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

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<0.001) and swelling (p<0.001) compared with placebo. Modified WOMAC scores for pain, stiffness, and difficulty in movements were also significantly (p<0.05) improved than placebo. The formulation demonstrated a significantly (p<0.001) faster onset and longer duration of action in terms of pain relief. Knee tenderness and rescue medication use were significantly (p<0.05) reduced. The formulation was well tolerated with no treatment-related adverse events (AEs).

Conclusions The topical pain relief cream formulation significantly reduced knee joint pain and swelling while improving joint function. These findings support its potential as a safe, fast acting and effective topical therapy for managing knee OA.