Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis

NCT07308470 | Not Yet Recruiting Phase 2

• 1 other identifier: PUA-PT-ETO-KOA-2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

osteoarthritis-Etodolac

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  Pain severity in patients with knee osteoarthritis measured using the Visual Analog Scale (VAS)Units on a 0-10 scale

  Baseline, 4 weeks, 8 week

Secondary Outcomes (3)

• Functional Improvement

  Baseline, 4 weeks, 8 weeks

• Patient Global Assessment of Disease Activity

  Baseline, 4 weeks, 8 weeks

• Physician's Global Assessmen

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel

EXPERIMENTAL

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

Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel

Traditional Physiotherapy Exercises

ACTIVE COMPARATOR

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

Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel

Interventions

Etodolac-Loaded Solid Lipid Nanoparticle Gel COMBINATION_PRODUCT

Physiotherapy program includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises

Also known as: Traditional Aerobic Training

Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel; Traditional Physiotherapy Exercises

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharos University in Alexandria: lead

Study Sites (1)

Pharos University-Faculty of Physical Therapy

Alexandria, 21614, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Yosra Elnagar, proffesor

CONTACT

01277629944; yosra.elnaggar@pua.edu.eg

ola elgohary, lecturer

CONTACT

01227191398; ola.elgohary@pua.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this single-blind study, the outcome assessor is blinded to group allocation to minimize measurement bias. Participants and physiotherapists are aware of the treatment they receive, but all assessments of pain, knee function, functional performance, quadriceps strength, and proprioception are conducted by a blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Physical Therapy for cardiopulmonary , Pharos University

Model Details: This is a randomized, parallel-assignment, single-blind interventional study. Thirty patients with mild to moderate unilateral knee osteoarthritis will be randomly assigned to either a control group receiving traditional physiotherapy or an experimental group receiving physiotherapy plus topical Etodolac-loaded nanoparticle gel. Outcome measures will be assessed at baseline and after 4 weeks to evaluate pain, knee function, functional performance, quadriceps strength, and proprioception

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 29, 2025
• Study Start: January 8, 2026
• Primary Completion: February 7, 2026
• Study Completion: March 7, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)