A Single-center, Open-label, Randomized, Parallel-group, Standard Therapy Controlled, Equivalence Clinical Trials to Evaluate the Efficacy and Safety of Structural Changes in the Spine to Determine the Traction Effect of an Investigational Device, Ceragem Master V6 (CGM MB-1701) Use in Patients With Lumber Disc Herniation & Degenerative Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anterior and posterior distance changes of L2-S1 intervertebral disc
研究概览
简要总结
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis.
详细描述
The efficacy and safety evaluation are conducted before and after the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day (Arm;Traction treatment) or standard physical therapy including temperature application and traction(Arm;Physical Therapy)
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who has been diagnosed with intervertebral disc herniation or degenerative stenosis (a person who has been diagnosed in the past or has been diagnosed upon obtaining consent)
- •Adult men and women over 19 years of age
- •Body mass index (BMI) 18.5 over to less than 30
排除标准
- •Subject with fibromyalgia, dystonia, and epilepsy
- •Subject with sensory impairment
- •Subject with physical irritation-induced skin lesions such as fever and compression (dermatosis, compression urticaria, choline urticaria, fever urticaria, etc.)
研究组 & 干预措施
Traction treatment
About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke
干预措施: Ceragem Master V6 Traction (Device)
Physical Therapy
About 40 minutes standard physical therapy including temperature application and traction
干预措施: Physical therapy with standard traction device (Device)
结局指标
主要结局
Anterior and posterior distance changes of L2-S1 intervertebral disc
时间窗: Immediately after application
Anterior and posterior distance changes of L2-S1 intervertebral disc are evaluated through X-Ray immediately after application of medical device compared to baseline
次要结局
- Changes in the range of waist movement(Immediately after application)
- Ratio of L2-S1 Anterior/posterior intervertebral distance(Immediately after application)
- Changes in lower extremity radiation pain(Immediately after application)
- Change in the angle evaluated by the SLR test(Immediately after application)