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

Ceragem Clinical Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cervical Kyphosis Cervical Lordosis Kyphosis

Interventions

CGM MB-1701 device treatmentDEVICE

This is a pre-approved motorized traction device.

CGM MB-1701 Sham device treatmentDEVICE

It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Outcomes

Primary Outcomes

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.

Time frame: up to 16 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: up to 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.