Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis

NCT ID: NCT07308470

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-08
• Study Completion Date: 2026-03-07

Brief 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

Keywords

osteoarthritis-Etodolac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel

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

Group Type: EXPERIMENTAL

Etodolac-Loaded Solid Lipid Nanoparticle Gel

Intervention Type: COMBINATION_PRODUCT

Physiotherapy program includes:

Quadriceps strengthening exercises

Lower limb muscle conditioning

Aerobic walking program

Functional mobility exercises

Traditional Physiotherapy Exercises

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

Group Type: ACTIVE_COMPARATOR

Etodolac-Loaded Solid Lipid Nanoparticle Gel

Intervention Type: COMBINATION_PRODUCT

Physiotherapy program includes:

Quadriceps strengthening exercises

Lower limb muscle conditioning

Aerobic walking program

Functional mobility exercises

Interventions

Etodolac-Loaded Solid Lipid Nanoparticle Gel

Physiotherapy program includes:

Quadriceps strengthening exercises

Lower limb muscle conditioning

Aerobic walking program

Functional mobility exercises

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Traditional Aerobic Training

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pharos University in Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Ola Mohamed Elsayed Elgohary

Lecturer, Department of Physical Therapy for cardiopulmonary , Pharos University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pharos University-Faculty of Physical Therapy

Alexandria, , Egypt

Countries

Egypt

Central Contacts

Yosra Elnagar, proffesor

Role: CONTACT

Phone: 01277629944

Email: yosra.elnaggar@pua.edu.eg

ola elgohary, lecturer

Role: CONTACT

Phone: 01227191398

Email: ola.elgohary@pua.edu.eg

References

Trojian, T. H., Concoff, A. L., Joy, S. M., Hatzenbuehler, J. R., Saulsberry, W. J., & Coleman, C. I. (2016). AMSSM scientific statement concerning viscosupplementation injections for knee osteoarthritis: importance for individual patient outcomes. British journal of sports medicine, 50(2), 84-92. 2 Murphy, L., Schwartz, T. A., Helmick, C. G., Renner, J. B., Tudor, G., Koch, G., ... & Jordan, J. M. (2008). Lifetime risk of symptomatic knee osteoarthritis. Arthritis Care & Research, 59(9), 1207-1213. 3 Altman, R., Lim, S., Steen, R. G., & Dasa, V. (2015). Hyaluronic Acid Injections Are Associated with Delay of Total Knee Replacement Surgery in Patients with Knee Osteoarthritis: Evidence from a Large US Health Claims Database. PloS one, 10(12). 4 Jegu AG, Pereira B, Andant N, and Coudeyre E. (2014). Effect of eccentric isokinetic strengthening in the rehabilitation of patients with knee osteoarthritis: Isogo, a randomized trial. Trials; 15(1): 106. 5 Segal, N. A., Williams, G. N., Davis, M. C., Wallace, R. B., & Mikesky, A. E. (2015). Efficacy of Blood Flow-Restricted, Low-Load Resistance Training in Women with Risk Factors for Symptomatic Knee Osteoarthritis. PM&R, 7(4), 376-384

Reference Type: BACKGROUND

Other Identifiers

PUA-PT-ETO-KOA-2025

Identifier Type: -

Identifier Source: org_study_id