Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etodolac-Loaded Solid Lipid Nanoparticle Gel.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: 45 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria
Overview
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
Interventions
- Combination product Etodolac-Loaded Solid Lipid Nanoparticle Gel
Physiotherapy program includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises
Primary outcome measures
- Pain Severity [Time frame: Baseline, 4 weeks, 8 week]
Secondary outcome measures (3)
- Functional Improvement [Time frame: Baseline, 4 weeks, 8 weeks]
- Patient Global Assessment of Disease Activity [Time frame: Baseline, 4 weeks, 8 weeks]
- Physician's Global Assessmen [Time frame: Baseline, 4 weeks, 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Pharos University-Faculty of Physical Therapy — Alexandria
Publications
- 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
Identifiers
NCT: NCT07308470 · PUA-PT-ETO-KOA-2025