Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease：A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 540
- 主要终点
- Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
研究概览
简要总结
This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients of case groups will receive P-PRP or PRP injection once a week for three times while the control group received the same dose compound betamethasone injection. Follow up visit will occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.
详细描述
All injection will be done under ultrasound guidance.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis;
- •symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
- •patient that can understand the clinical trials and signed the informed consent.
排除标准
- •patient that underwent other injection treatment within 6 weeks
- •some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
- •patient that enrolled other clinical trials within 3 months
- •history of drug/alcohol addiction, habitual smoker
研究组 & 干预措施
P-PRP
Blood will be drawn and pure platelet-rich plasma will be injected into the tendon.
干预措施: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection (Biological)
PRP
Blood will be drawn and platelet-rich plasma will be injected into the tendon.
干预措施: Ultrasound-guided platelet-rich-plasma (PRP) injection (Biological)
Compound betamethasone
1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) )
干预措施: Ultrasound-guided Compound betamethasone injection (Drug)
结局指标
主要结局
Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
时间窗: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Pain on activity will be evaluated by VAS
次要结局
- Constant-Murley Score(CMS)(Baseline, 3 weeks, 6 weeks, 12 weeks after intervention)
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score(Baseline, 3 weeks, 6 weeks, 12 weeks after intervention)
- The Disabilities of the Arm, Shoulder and Hand(DASH) Score(Baseline, 3 weeks, 6 weeks, 12 weeks after intervention)
- Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)(Baseline, 3 weeks, 6 weeks, 12 weeks after intervention)
- Adverse events(From baseline through study completion, an average of 3 year)