Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Pain Reduction
研究概览
简要总结
"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.
Many treatments have been attempted, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other non-affected arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (platelet rich plasma) is a newer, but expensive, technique.
At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment.
The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult man or woman aged 18 years or greater.
- •Clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension.
- •Documented sonographic diagnosis of common extensor tendinosis based on tendon thickening, areas of hypoechogenicity, and loss of the normal echotexture.
- •Chronic symptoms (equal or greater than 3 months).
- •Pain of at least 5 out of 10 on a visual analog scale (VAS).
- •Provision of informed consent.
排除标准
- •Acute symptom onset (less than 2 months).
- •History of acute elbow trauma (less than one week).
- •History of rheumatoid arthritis.
- •History of malignancy.
- •Pregnancy
- •Patients requiring anti-platelet medication for the treatment of heart attack, stroke or other medical condition.
- •Previous surgery for lateral epicondylitis.
- •Previous local injections, including steroids within the past 6 months.
- •Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion).
结局指标
主要结局
Pain Reduction
时间窗: Baseline, 6 weeks, 3, 6, 12 months
Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).
次要结局
- Psychological Impairment(Baseline, 6 weeks, 3, 6, 12, 24 months)
- Functional Disability(Baseline, 6 weeks, 3, 6, 12, 24 months)
- Health-Related Quality of Life(Baseline, 6 weeks, 3, 6, 12, 24 months)