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Completed

NCT Number: NCT05469295

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

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.

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Key information

Conditions

Cervical Kyphosis Bone Diseases Cervical Lordosis Kyphosis Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
  • BMI betweeen 18.5 and 30
  • Chronic neck pain NRS 4 or higher lasting more than 3 months

Exclusion criteria

  • Secondary spondylosis
  • A tumor of the spine
  • Inflammatory spondylitis
  • Myelopathy
  • Multiple adjacent radiculopathies and others

Treatment and study plan

CGM MB-1701 device treatment

Device

This is a pre-approved motorized traction device.

CGM MB-1701 Sham device treatment

Device

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

Primary outcomes

  1. Mean change of cervical lordosis

    Time frame: 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 outcomes

  1. Change of cervical lordosis at 2nd interim analysis

    Time frame: 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.

  2. Cervical vestibular angle increase more than 10 degrees

    Time frame: 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

  3. Anteroposterior (T1) slope average change

    Time frame: up to 16 weeks

    Average change in cervical anteroposterior (T1) slope measured by cervical lateral radiography at each evaluation compare to the baseline

Sponsors and collaborators

Lead sponsor

Ceragem Clinical Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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