A Prospective, Randomized, Single-blinded, Sham Device Controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 in Subjects With Cervical Kyphosis and Posterior Neck Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change of cervical lordosis
研究概览
简要总结
The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior Neck Pain.
详细描述
The Cervical Kyphosis are also commonly referred to as "turtle neck syndrome." It refers to the deformation of the neck bone into an inverted C-shape due to abnormalities or degenerative changes, and it is named to mean that the neck is bent like a turtle.
This device, Ceragem Master V6 (CGM MB-1701), has been certified as a combination of a personal warmer that can be used to relieve muscle pain by applying constant heat to the human body and a medical vibrator of a device that applies physical energy (vibration, shock, pressure, etc.). Also, the device got approval for use with intermittent pneumatic compression and electrically-powered orthopedics traction.
The primary purpose of this clinical trial is to confirm the temporary cervical lordosis angle improvement (height) in subjects with cervical kyphosis through the combined function of the test device.
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, Investigator, Outcomes Assessor)
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
- •Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
- •Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
- •BMI betweeen 18.5 and 30
- •Chronic neck pain NRS 4 or higher lasting more than 3 months
排除标准
- •Secondary spondylosis
- •A tumor of the spine
- •Inflammatory spondylitis
- •Multiple adjacent radiculopathies and others
研究组 & 干预措施
CGM_MB_1701 treatment
Subjects will be treated with the study device for about 36 minutes.
干预措施: CGM MB-1701 device treatment (Device)
Sham (CGM MB1701C) treament
Subjects will be treated with the Sham device for about 36 minutes.
干预措施: CGM MB-1701 Sham device treatment (Device)
结局指标
主要结局
Mean change of cervical lordosis
时间窗: up to 16 weeks
Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline.
次要结局
- Cervical vestibular angle increase more than 10 degrees(up to 16 weeks)
- Anteroposterior (T1) slope average change(up to 16 weeks)
- Change of cervical lordosis at 2nd interim analysis(up to 16 weeks)