Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain Severity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Severity
时间窗: 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
次要结局
- Functional Improvement(Baseline, 4 weeks, 8 weeks)
- Patient Global Assessment of Disease Activity(Baseline, 4 weeks, 8 weeks)
- Physician's Global Assessmen(Baseline, 4 weeks, 8 weeks)
研究者
Ola Mohamed Elsayed Elgohary
Lecturer, Department of Physical Therapy for cardiopulmonary , Pharos University
Pharos University in Alexandria