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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etodolac-Loaded Solid Lipid Nanoparticle Gel | Combination Product | Physiotherapy program includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Improvement | Improvement in knee function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale-Units on a 0-68 scale | Baseline, 4 weeks, 8 weeks |
| Patient Global Assessment of Disease Activity |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yosra Elnagar, proffesor | Contact | 01277629944 | yosra.elnaggar@pua.edu.eg | |
| ola elgohary, lecturer | Contact | 01227191398 | ola.elgohary@pua.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharos University-Faculty of Physical Therapy | Alexandria | 21614 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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Reason: Data contains sensitive patient information and will be used only for the purposes of this study under confidentiality agreements.
Access: Data may be available upon reasonable request to the principal investigator for approved research purposes, following ethical and institutional approvals
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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
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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.
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Patient's overall assessment of their osteoarthritis symptoms measured using a 0-100 scaleوUnits on a 0-100 scale |
| Baseline, 4 weeks, 8 weeks |
| Physician's Global Assessmen | Physician's assessment of the patient's overall osteoarthritis status using a standardized scale-Units on a 0-100 scale | Baseline, 4 weeks, 8 weeks |
| D012216 |
| Rheumatic Diseases |