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

Kyphosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05469295
• Other study ID #: CRG_MV6_P03
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2023
• Source: Ceragem Inc.
• Contact: Hyungsun Kim
• Phone: 82-10-4597-6672
• Email: hyungsun.kim[@]ceragem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.

3. BMI betweeen 18.5 and 30

4. Chronic neck pain NRS 4 or higher lasting more than 3 months

Exclusion Criteria:

1. Secondary spondylosis

2. A tumor of the spine

3. Inflammatory spondylitis

4. Myelopathy

5. Multiple adjacent radiculopathies and others

Related Conditions & MeSH terms

• Kyphosis
• Lordosis

Intervention

Device:
• CGM MB-1701 device treatment
This is a pre-approved motorized traction 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ceragem Clinical Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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