A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 2. The American Shoulder and Elbow Society score – To evaluate the effect of HPL on pain, function, range of motion, strength and patient satisfaction on various numerical scales.
研究概览
简要总结
This is a multicentre, openlabel, randomized, pilot study to evaluate safety and efficacy of humanPlatelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers inIndia. The primary end points are Visual Analog Score(VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondaryendpoint is improvement in ultrasonography form randomization to End of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with clinical diagnosis of tennis elbow within the last 3 months 2.Subjects both male and female, aged 18-60 years (both inclusive) 3.Subjects who are willing to give informed consent and adhere to the study protocol.
排除标准
- •1.Subjects aged less than 18 and more than 60 years 2.Subjects with autoimmune diseases 3.Subjects with immuno-compromised system 4.Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin 5.Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
- •6.Subjects who have received treatment with corticosteroid injections within the last 6 months.
结局指标
主要结局
2. The American Shoulder and Elbow Society score – To evaluate the effect of HPL on pain, function, range of motion, strength and patient satisfaction on various numerical scales.
时间窗: End of study - 3 Months
3. All the above questionnaires are externally validated clinical outcome measures that rate elbow pain
时间窗: End of study - 3 Months
1. Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score: To evaluate the effect of HPL on Pain Scores.
时间窗: End of study - 3 Months
次要结局
- Ultrasonography(End of study - 3 Months)