Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-60
SponsorPharos University in Alexandria

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 45 and 60 years.

Disqualifiers

Severe or bilateral knee osteoarthritis (Kellgren-Lawrence grade IV).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Etodolac-Loaded Solid Lipid Nanoparticle Gel

    Combination product

    Physiotherapy program includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Traditional Physiotherapy + Etodolac-Loaded Nanoparticle GelExperimental treatment 1 intervention
Group B: Traditional Physiotherapy ExercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Severity

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 week

Secondary outcomes

1

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

Time frame
Baseline, 4 weeks, 8 weeks
2

Patient Global Assessment of Disease Activity

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
3

Physician's Global Assessmen

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

Time frame
Baseline, 4 weeks, 8 weeks

Other outcomes

Sponsors and contacts

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