Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Constant score (Shoulder function score)
研究概览
简要总结
Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.
详细描述
Suitable participants based on the selection/exclusion criteria are randomly assigned to either the case group or the control group. Consent is given right before the procedure.
Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine and atelocollagen injection.
Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine injection."
Clinical outcomes will be assessed with functional scores on 6 months after injection.
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in whom calcification of 5mm or more is observed in plain radiographs.
- •In cases where concomitant medication is administered continuously during the clinical trial period, patients who have verified the exact prescribed medication taken within the last week and agreed to maintain the same amount throughout the study period.
- •Individuals who have agreed to participate in this study and have given written consent themselves.
排除标准
- •Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.
- •Patients with hypersensitivity.
- •Patients with a history of anaphylactic reactions.
- •Patients with ongoing autoimmune diseases or a past medical history of such diseases, either in the patient or their family members.
- •Patients who are allergic to transplants. ⑥ Patients who are allergic to porcine (pig) proteins.
- •⑦ Patients deemed unsuitable for this trial based on the judgment of the trial administrator, such as those with mental illnesses.
- •⑧ Patients who have received intra-articular steroid or other injection treatments within one month prior to the procedure decision.
- •⑨ Patients who are on concomitant medications that include oral steroids.
结局指标
主要结局
Constant score (Shoulder function score)
时间窗: 1, 3, 5 months
The Constant score is commonly used to evaluate the functional status of shoulder disorders and shows relatively high accuracy, reliability, and reproducibility. The evaluation is out of a total of 100 points: pain 15 points, daily activities 20 points, anterior elevation 10 points, lateral elevation 10 points, internal/external rotation each 10 points, and muscle strength 25 points
次要结局
未报告次要终点
研究者
Hyungsuk Kim
Assistant professor
The Catholic University of Korea