NCT05469295

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ceragem Clinical Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 and Posterior Neck Pain.

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.

Conditions

• Cervical Kyphosis
• Cervical Lordosis
• Kyphosis

Interventions

Type	Name	Description
DEVICE	CGM MB-1701 device treatment	This is a pre-approved motorized traction device.
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.

Timeline

• Start date: 2023-05-09
• Primary completion: 2024-07-26
• Completion: 2024-07-26
• First posted: 2022-07-21
• Last updated: 2026-02-09

Locations

1 site across 1 country: South Korea