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.

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.

Study Overview

• Status: Completed
• Conditions: Kyphosis; Cervical Kyphosis; Cervical Lordosis
• Intervention / Treatment: Device: CGM MB-1701 device treatment; Device: CGM MB-1701 Sham device treatment

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Yangsan, South Korea
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ceragem Clinical Inc.
• Investigators: Principal Investigator: Yong Il Shin, MD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Kyphosis
• Other Study ID Numbers: CRG_MV6_P03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No