CETIC-I (CEra Traction Improves Cervical Kyphosis -I)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cervical Kyphosis, Cervical Lordosis, Kyphosis

Intervention / Treatment
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* Device: CGM MB-1701 device treatment
* Device: CGM MB-1701 Sham device treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Secondary spondylosis A tumor of the spine Inflammatory spondylitis Myelopathy Multiple adjacent radiculopathies and others

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM_MB_1701 treatment<br>Subjects will be treated with the study device for about 36 minutes. | Device: CGM MB-1701 device treatment<br>* This is a pre-approved motorized traction device.<br>|
| Sham Comparator: Sham (CGM MB1701C) treament<br>Subjects will be treated with the Sham device for about 36 minutes. | Device: CGM MB-1701 Sham device treatment<br>* It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of cervical lordosis | Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline. | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cervical lordosis at 2nd interim analysis | Change of the cervical lordosis (posterior tangent method of Harrison) measured by cervical lateral radiography at the 2nd interim visit compared to baseline. | up to 16 weeks | 
| Cervical vestibular angle increase more than 10 degrees | The fraction of subjects whose cervical vestibular angle measured by the posterior tangent method of Harrison at each time of evaluation increased by more than 10 degrees compared to the baseline | up to 16 weeks | 
| Anteroposterior (T1) slope average change | Average change in cervical anteroposterior (T1) slope measured by cervical lateral radiography at each evaluation compare to the baseline | up to 16 weeks |