NCT05528705已完成不适用
A Randomized, Parallel-group, Placebo-controlled, Single-blind, Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome
Green Cross Wellbeing3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change amoust of VAS (visual analogue scale)
研究概览
简要总结
To patients with shoulder collision syndrome, LAENNEC (Human Placenta Hydrolysate) is administered as an injection in the ultrasonic induction underglone, to evaluate the effectiveness and safety.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of screening, 19 or 70 years
- •Those who are suspected of rotator cuff lesions or damage due to shoulder pain
- •Those who are judged to have a shoulder joint disease during screening
- •Neer test, Hawkins-Kennedy inspection, job test, Painful Arc inspection or resisted showder external rotation test
- •Those with a significant pain of 30 mm of Visual Analogue Scale (VAS)
- •Those who can sign a test subject or to comply with the matters required for clinical trials.
排除标准
- •A person who appears in the movement of two or more shoulder joints with more than 50% of the joint movement limit on the passive shoulder joint operation scope test.
- •Those who have confirmed the rupture of the entire layer by ultrasound
- •Those with serious damage to the shoulders and the past power
- •Those who have suspected fractures, dislocations, degenerative arthritis, and calcification in the shoulder radiation test in the shoulder radiation test.
- •Those who complain of shoulder pain due to stroke, spinal cord injury, and other surgery
- •Those with other shoulder diseases other than fifty dogs (rheumatoid arthritis, osteoarthritis, bone defect injuries, malignant tumors, etc.)
- •Those who are accompanied by diseases of cervical spine or other upper limbs that have a significant effect on the shoulder
- •Those who have performed steroid injections in the joint steel within 3 months of participation in clinical trials
- •Those who have administered anti -inflammatory drugs within two weeks of participation in clinical trials
- •Those with all other joint diseases that have musculoskeletal diseases that may affect effective evaluation, or that it is impossible to participate in this clinical trial.
- •Those who are diagnosed with mental illness and taking drugs
- •Pregnant women and lactation departments, fertility women who are not willing to contraceptive during the clinical trial period
- •Those who have received medication, oriental medicine, physical therapy, and injection treatment in relation to shoulder pain within the last two weeks 14 Those who are participating in other clinical trials during screening
- •15. Those who determine that other testors are inadequate
研究组 & 干预措施
LAENNEC
Experimental
4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment
干预措施: LAENNEC (Biological)
0.9% Normal saline
Active Comparator
4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment
干预措施: 0.9% normal saline (Other)
结局指标
主要结局
Change amoust of VAS (visual analogue scale)
时间窗: week 0 and 12
次要结局
- Change amoust of SPADI(week 1, 2, 3, 6 and 12)
- Change amoust of EQ-5D-5L(week 1, 2, 3, 6 and 12)
- Change amoust of VAS (visual analogue scale)(week 1, 2, 3 and 6)
研究者
研究点 (3)
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