Efficacy and safety of low-dose celecoxib in patients with mild to moderate knee osteoarthritis: a protocol for a single-center, randomized, double-blind, parallel-group controlled trial
Abstract
Background: Knee osteoarthritis (OA) is a prevalent degenerative joint disease characterized by cartilage degradation and inflammation, leading to pain and functional limitations. Emerging evidence suggests that physiological levels of prostaglandin E2 (PGE2) are crucial for maintaining subchondral bone remodeling balance via skeletal interoception. More and more evidence supports that standard dose or higher doses of celecoxib (≥ 200 mg/day) may disrupt this balance by significantly reducing PGE2 levels, potentially accelerating OA progression. This study aims to compare the efficacy of conventional-dose celecoxib (200 mg/day) versus low-dose celecoxib (100 mg/day) in treating patients with mild to moderate knee OA over a 3-month treatment period and 3-month follow-up.
Methods: This randomized, double-blind, parallel-group trial will enroll 200 participants diagnosed with mild to moderate knee OA (Kellgren-Lawrence grades I-III), who will be randomized in a 1:1 ratio to receive either conventional (200 mg/day) or low-dose (100 mg/day) celecoxib for consecutive 3 months. After the administration, patients were followed up for 3 months. The primary outcome will be the change in pain intensity, which was measured using the visual analog scale (VAS), from baseline to 24 weeks, evaluated via the VAS. Secondary outcomes include biomarkers of bone metabolism and safety parameters, including Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subchondral bone…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.
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