Knee Osteoarthritis
Conditions
Keywords
osteoarthritis-Etodolac
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.
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_PRODUCTEtodolac-Loaded Solid Lipid Nanoparticle Gel
Physiotherapy program includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises
Sponsors
Pharos University in Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement | 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 |
| Patient Global Assessment of Disease Activity | Baseline, 4 weeks, 8 weeks | Patient's overall assessment of their osteoarthritis symptoms measured using a 0-100 scaleوUnits on a 0-100 scale |
| Physician's Global Assessmen | 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 |
Countries
Egypt
Contacts
Primary ContactYosra Elnagar, proffesor
Backup Contactola elgohary, lecturer
Outcome results
None listed