Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis

Pharos University in Alexandria

Status and phase: Not yet enrolling; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07308470

PUA-PT-ETO-KOA-2025

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 45 and 60 years.

Mild to moderate unilateral knee osteoarthritis (Kellgren-Lawrence grades II-III).

Ability to walk independently without assistive devices.

Body Mass Index (BMI) < 30 kg/m².

No participation in resistance training in the 3 months prior to enrollment.

Referred by an orthopedic surgeon and diagnosed based on clinical and radiological examination.

Exclusion criteria

• Severe or bilateral knee osteoarthritis (Kellgren-Lawrence grade IV).

Congenital or acquired inflammatory, rheumatic, or neurological disorders affecting the knee.

Repeated treatment with steroids or secondary knee OA.

History of joint replacement surgery in the knee or hip.

Cardiovascular or neuromuscular disorders.

Diabetes mellitus.

Psychiatric disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel

Experimental group

Description:

Participants will receive the same structured physiotherapy program as the control group, in addition to topical application of Etodolac-loaded solid lipid nanoparticle gel on the affected knee. Physiotherapy components: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises Etodolac nanogel application: Applied topically according to the study protocol to provide localized analgesic and anti-inflammatory effects. Duration: 4 weeks, with standardized physiotherapy sessions and daily topical gel application. Purpose: To evaluate whether adding Etodolac-loaded nanoparticle gel enhances pain relief, knee function, functional performance, quadriceps strength, and proprioception compared with physiotherapy alone

Treatment:

Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel

Traditional Physiotherapy Exercises

Active Comparator group

Description:

Participants will receive a structured physiotherapy program for knee osteoarthritis, which includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises Duration: 4 weeks, following standardized procedures for all participants. Purpose: To serve as the control group for comparison with the experimental group receiving additional Etodolac-loaded nanoparticle gel

Treatment:

Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel