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

Ceragem Clinical

Status: Not yet enrolling

Conditions: Cervical Lordosis; Cervical Kyphosis; Kyphosis

Treatments: Device: CGM MB-1701 Sham device treatment; Device: CGM MB-1701 device treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05469295

CRG_MV6_P03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

CGM_MB_1701 treatment

Experimental group

Description:

Subjects will be treated with the study device for about 36 minutes.

Treatment:

Device: CGM MB-1701 device treatment

Sham (CGM MB1701C) treament

Sham Comparator group

Description:

Subjects will be treated with the Sham device for about 36 minutes.

Treatment:

Device: CGM MB-1701 Sham device treatment