Cervical Kyphosis Pilot Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CGM_MB_1701 treatment Subjects will be treated with the study device for about 36 minutes. |
Device: CGM MB-1701 device treatment
This is a pre-approved motorized traction device.
|
| Sham Comparator: Sham (CGM MB1701C) treament Subjects will be treated with the Sham device for about 36 minutes. |
Device: CGM MB-1701 Sham device treatment
It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized.
|
Outcome Measures
Primary Outcome Measures
- Mean change of cervical lordosis [12 weeks]
Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT compared to baseline.
Secondary Outcome Measures
- Change of cervical lordosis at 2nd interim analysis [6 weeks]
Change of the cervical lordosis (posterior tangent method of Harrison) measured by cervical lateral radiography at the 2nd interim visit compared to baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
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BMI betweeen 18.5 and 30
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Swallowing Impairment Index-6, at least 1 point out of 6 items
Exclusion Criteria:
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Secondary spondylosis
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A tumor of the spine
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Inflammatory spondylitis
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Myelopathy
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Multiple adjacent radiculopathies and others
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ceragem Clinical Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRG_MV6_P03