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NCT Number: NCT07308470

Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis

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.

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Key information

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pharos University-Faculty of Physical Therapy

Alexandria, 21614, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etodolac-Loaded Solid Lipid Nanoparticle Gel

Combination Product

Physiotherapy program includes:

Quadriceps strengthening exercises

Lower limb muscle conditioning

Aerobic walking program

Functional mobility exercises

Other names: Traditional Aerobic Training

Primary outcomes

  1. Pain Severity

    Time frame: Baseline, 4 weeks, 8 week

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

Secondary outcomes

  1. Functional Improvement

    Time frame: Baseline, 4 weeks, 8 weeks

    Improvement in knee function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale-Units on a 0-68 scale

  2. Patient Global Assessment of Disease Activity

    Time frame: Baseline, 4 weeks, 8 weeks

    Patient's overall assessment of their osteoarthritis symptoms measured using a 0-100 scaleوUnits on a 0-100 scale

  3. Physician's Global Assessmen

    Time frame: Baseline, 4 weeks, 8 weeks

    Physician's assessment of the patient's overall osteoarthritis status using a standardized scale-Units on a 0-100 scale

Study contacts

Contact information is provided by the study sponsor or research team.

Yosra Elnagar, proffesor

CONTACT

[email protected]

01277629944

ola elgohary, lecturer

CONTACT

[email protected]

01227191398

Sponsors and collaborators

Lead sponsor

Pharos University in Alexandria

Other

Registry information

Official study title

Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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