Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Visual Analogue Scale,VAS
研究概览
简要总结
The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible.
详细描述
The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients' pain and return to normal life as soon as possible.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the diagnostic criteria for rotator cuff calcific tendonitis, aged between 40 and 60 years old
- •Persistent pain in the affected shoulder, with obvious tenderness under the acromion and rotator cuff, as confirmed by X-ray and Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) examination showed one or more round-shaped high-density calcium salt deposits near the greater tuberosity of the humerus
- •All were diagnosed for the first time
- •Complaints of severe pain in the shoulder joint, obvious
排除标准
- •Combined with rotator cuff trauma, long head of biceps tendonitis and other shoulder joint diseases
- •Past combined history of shoulder joint surgery
- •Patients with internal fixation of the shoulder joint
- •Shoulder joint combined with infection, Tumors and other lesions
- •Combined with severe heart, liver, and kidney dysfunction
- •Do not agree to participate in the study or fail to sign the informed consent form.
结局指标
主要结局
Visual Analogue Scale,VAS
时间窗: After 1, 2, 4 and 8 weeks of intervention
The full name of the Scale is Visual Analogue Scale, that is, visual analogue scale. Minimum value and maximum value: the minimum value of the VAS scale is 0, indicating "completely painless" or "painless end"; The maximum value is 10, which indicates "the most severe pain imaginable" or "the most severe pain end." Score Significance: On the VAS scale, a higher score means a worse outcome, i.e. a greater degree of pain. The patient marks the corresponding position on the scale according to their pain experience, thus indicating the intensity of the pain.
次要结局
- the university of California at Los Angeles shoulder rating scale, UCLA(After 1, 2, 4 and 8 weeks of intervention)
- American Shoulder and Elbow Surgeon's Form,ASES(After 1, 2, 4 and 8 weeks of intervention)
- The location and size of the calcifications were examined by ultrasound(After 4 and 8 weeks of intervention)
研究者
Xiali Xue
Clinical Professor
Chengdu Sport University