Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 2D Kinematic Data
研究概览
简要总结
Anterior Knee Pain (AKP) is a common condition that can be challenging to treat effectively. The main goal of treatment regimens is to improve the function of the knee. However, treatment can be challenging due to the knee pain experience. Cingal™ contains hyaluronic acid (HA), which acts as a joint lubricant, and the corticosteroid triamcinolone hexacetonide (TH). Some studies have shown that Cingal™ can improve joint function and provide short-term pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 35 years
- •Standard weight-bearing AP and skyline view knee x-rays
- •Retropatellar or peripatellar knee pain for a minimum of 2 months
- •Confirmed diagnosis of AKP that has failed to improve with a minimum of 6 weeks of conservative treatment (activity modification, supervised physiotherapy, exercise therapy, taping or bracing, NSAIDS)
- •Pain aggravated by at least two of the following patellofemoral joint loading activities: squatting, running, ascending or descending stairs, or sitting with prolonged knee flexion.
排除标准
- •X-ray evidence of knee osteoarthritis or fracture
- •Meniscal or ligamentous injury assessed or suspected on clinical examination
- •Previous knee surgery
- •History of patellar instability
- •Any contraindication to knee injection (overlying skin condition, joint infection, significant joint effusion, coagulopathy, previous adverse reaction, etc.)
- •Known allergy to Cingal™ or its constituents
- •Previous knee injection within the last 3 months
- •BMI greater than 30 kg/m2
- •Diabetes, inflammatory conditions (rheumatologic disease, ankylosing spondylitis), or concurrent medical conditions which may result in chronic pain or altered pain sensation
- •Pregnant or breastfeeding
- •Workers Compensation Board case
- •Patient involved in litigation
研究组 & 干预措施
Cingal Injection
Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 20-gauge needle into the joint space of the knee under sterile conditions. The needle track will be anesthetized with local anesthetic.
干预措施: Cingal (Device)
结局指标
主要结局
2D Kinematic Data
时间窗: baseline, 6 weeks, 12 weeks
Kinematic data will be collected at baseline and 6 and 12 weeks after administration of the Cingal™ injection. Outcome measures include ankle dorsiflexion at contact, maximum rear foot eversion, knee flexion at contact, knee adduction in late stance, and hip joint angle. In addition, the mean of three angle measurements for each parameter will be recorded.
次要结局
- Strength Testing(baseline, 12 weeks)
- Biomechanical Assessment(baseline, 12 weeks)
- Pain scores measured using a 100 mm Visual Analog Scale (VAS)(baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks)
- Anterior knee pain using the Anterior Knee Pain Scale (AKPS)(baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks)
- General activity rating using the Marx Activity Score(baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks)
- Symptoms of knee injury using the Knee Injury and Osteoarthritis Outcomes Score (KOOS)(baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks)