The Clinical and Biological Effect of Extracorporeal Shock Wave Technology (ESWT) With Combined PRP Therapy on Rotator Cuff Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Range of Motion (ROM)
研究概览
简要总结
Through the investigators previous study of the effect of transient increased cellular permeability after ESWT, combined ESWT and PRP may have better effect on the treatment of rotator cuff lesions. The investigators intend to conduct a prospective double blind randomized control study on the treatment effect of combined ESWT and PRP therapy for rotator cuff lesions without complete tearing. Constant Score, VAS and data from peripheral blood will be measured for the effectiveness evaluation. Shoulder MRI will be followed-up one year after ESWT. The investigators hypothesize that combined ESWT and PRP will be more effective for rotator cuff lesions.
详细描述
Overall Design [Prospective randomized double-blind study for the clinical effect of combined ESWT and platelet-rich plasma (PRP) or PRP or ESWT alone or sham treatment on patients with shoulder rotator cuff lesions and without complete tear.]
The participants will be separated into 4 groups according to computer statistical randomization.
The investigators shall use STORZ MEDICAL Extracorporeal Shock Wave Therapy 3000 impulse 24KV (0.32mJ/mm2) Focus at two points (3000 impulse each point) near the insertion of supraspinatus and rotation interval of the involved shoulder.
PRP： The PRP form Regen Kit BCT 1 Platelet Rich Plasma PRP will be used and will be injected into the Subacromial bursa (Hyajoint injection as a control)
HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain around the shoulder, a positive impingement sign, imaging diagnosis of rotator cuff pathology without complete tear
- •do not respond to conservative therapy or rehabilitation for at least 3 months
- •age between 35 and 80 years, who sign the informed consent form.
排除标准
- •rheumatic diseases, SLE, diabetic neuropathy, glenohumeral osteoarthritis, full-thickness cuff tears, fractures, infections, or tumors
- •received a subacromial injection within 3 weeks
- •pregnant or want to become pregnant.
- •arrhythmia, pacemaker, coagulopathy, or malignancy
结局指标
主要结局
Range of Motion (ROM)
时间窗: measure and record at 12 months after treatment.
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.
MRI
时间窗: shoulder MRI will be checked 12 months after treatment
Take shoulder MRI to compare the difference before and after treatment. The degeneration of the supraspic is graded as: grade 1 ≤ 1/3; 1/3 \< grade 2 \< 2/3; grade 3 ≥ 2/3.
Constant Score
时间窗: measure and record at 12 months after treatment.
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 12 months after treatment.
visual analog scale (VAS)
时间窗: measure and record at 12 months after treatment.
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.
次要结局
未报告次要终点
研究者
Jih-Yang Ko
Professor
Chang Gung Memorial Hospital