Randomized Controlled Double Blind Study of Bee Venom Therapy on Adhesive Capsulitis of the Shoulder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose effective.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of frozen shoulder by orthopedist
- •Must have shoulder pain of more than VAS 5 over 1 month and under 12 months
- •Marked limitation of active and/or passive motion range in one shoulder
排除标准
- •history of major shoulder injury or surgery
- •other musculoskeletal pain
- •cervical neuropathy, paralysis, neurological disorder
- •hypersensitivity reactions by bee venom skin test
- •renal or hepatic disorders, hematologic diseases, cancer, mental disorders, inflammatory or infectious disorders
研究组 & 干预措施
BV1
1:10,000 bee venom (BV) acupuncture plus physiotherapy
干预措施: 1:10,000 bee venom (BV) acupuncture (Procedure)
BV1
1:10,000 bee venom (BV) acupuncture plus physiotherapy
干预措施: physiotherapy (Procedure)
BV2
1:30,000 bee venom (BV) acupuncture plus physiotherapy
干预措施: 1:30,000 bee venom (BV) acupuncture (Procedure)
BV2
1:30,000 bee venom (BV) acupuncture plus physiotherapy
干预措施: physiotherapy (Procedure)
NS
Normal saline injection plus physiotherapy
干预措施: normal saline injection (Procedure)
NS
Normal saline injection plus physiotherapy
干预措施: physiotherapy (Procedure)
结局指标
主要结局
the Shoulder Pain and Disability Index (SPADI)
时间窗: Changes from baseline in SPADI at 2, 4, 8, 12 weeks
次要结局
- Visual Analogue Scale (VAS) for pain intensity(Changes from baseline in VAS at 2, 4, 8, 12 weeks)
- passive Range of Motion (pROM)(Changes from baseline in pROM at 2, 4, 8, 12 weeks)
研究者
Yonghyeon Baek
Assisstant Professor
Kyunghee University Medical Center