Pharos University-Faculty of Physical Therapy
Alexandria, 21614, Egypt
NCT Number: NCT07308470
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.
Trial opening soon.
Get Notified45 year–60 year
All sexes
Interventional
Phase 2
Alexandria, 21614, Egypt
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Physiotherapy program includes:
Quadriceps strengthening exercises
Lower limb muscle conditioning
Aerobic walking program
Functional mobility exercises
Other names: Traditional Aerobic Training
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
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
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
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
Contact information is provided by the study sponsor or research team.
Yosra Elnagar, proffesor
CONTACT
ola elgohary, lecturer
CONTACT
Pharos University in Alexandria
Other
Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria
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