Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM_MB_1701 treatment | Experimental | Subjects will be treated with the study device for about 36 minutes. |
|
| Sham (CGM MB1701C) treament | Sham Comparator | Subjects will be treated with the Sham device for about 36 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM MB-1701 device treatment | Device | This is a pre-approved motorized traction device. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yong Il Shin, MD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007738 | Kyphosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CGM MB-1701 Sham device treatment | Device | It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized. |
|
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 |