NCT07308470

Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis

Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Pharos University in Alexandria · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Brief Summary: Knee osteoarthritis (OA) is a common, disabling condition affecting the weight-bearing knee joint, leading to pain, reduced function, and muscle weakness, particularly of the quadriceps. Strengthening exercises are recommended to improve joint stability, physical function, and slow disease progression. Etodolac, a selective NSAID approved for osteoarthritis, has proven analgesic and anti-inflammatory effects. This study investigates the adjunctive effect of a topical Etodolac-loaded solid lipid nanoparticle gel combined with traditional physiotherapy in patients with knee OA. Thirty patients with mild to moderate unilateral tibiofemoral OA will be randomized into two groups: traditional physiotherapy alone or physiotherapy plus Etodolac gel. Outcomes including pain, knee function, functional performance, quadriceps strength, and proprioception will be assessed at baseline and after four weeks. The study aims to determine whether adding topical Etodolac enhances the benefits of standard physiotherapy in managing knee OA.

Detailed description

This randomized clinical trial investigates the effect of adding a topical Etodolac-loaded solid lipid nanoparticle gel to traditional physiotherapy in patients with mild to moderate unilateral knee osteoarthritis (OA). Thirty patients aged 45-60 years will be randomly assigned to either physiotherapy alone (control) or physiotherapy plus Etodolac nanogel (experimental) for 4 weeks. Outcomes include pain (VAS), knee function (WOMAC), functional performance (TUG, 2MWT), quadriceps strength, and proprioception. The study aims to determine whether the combination therapy provides superior pain relief, improved joint function, and enhanced muscle performance compared with physiotherapy alone, while potentially reducing systemic NSAID exposure

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Etodolac-Loaded Solid Lipid Nanoparticle Gel	Physiotherapy program includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises

Timeline

• Start date: 2026-01-08
• Primary completion: 2026-02-07
• Completion: 2026-03-07
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Egypt