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

Not Applicable

Not yet recruiting

• Conditions: Kyphosis; Cervical Lordosis; Cervical Kyphosis
• Interventions: Device: CGM MB-1701 device treatment; Device: CGM MB-1701 Sham device treatment

• Registration Number: NCT05469295
• Lead Sponsor: Ceragem Clinical Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Study Start: 2023-05-01
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-06-28
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM_MB_1701 treatment	CGM MB-1701 device treatment	Subjects will be treated with the study device for about 36 minutes.
Sham (CGM MB1701C) treament	CGM MB-1701 Sham device treatment	Subjects will be treated with the Sham device for about 36 minutes.

Primary Outcome Measures

Name	Time	Method
Mean change of cervical lordosis	up to 16 weeks	Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Cervical vestibular angle increase more than 10 degrees	up to 16 weeks	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
Anteroposterior (T1) slope average change	up to 16 weeks	Average change in cervical anteroposterior (T1) slope measured by cervical lateral radiography at each evaluation compare to the baseline
Change of cervical lordosis at 2nd interim analysis	up to 16 weeks	Change of the cervical lordosis (posterior tangent method of Harrison) measured by cervical lateral radiography at the 2nd interim visit compared to baseline.