Skip to main content
OpenTrials
Completed

NCT Number: NCT05549596

CETIS-I (CEra Traction Improves Spine-I)

In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Disc Herniation Bone Diseases Degenerative Spinal Stenosis Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spine Traction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Presbyterian Medical Center

Jeonju, South Korea

About this study

The efficacy and safety evaluation are conducted before and after the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day (Arm;Traction treatment) or standard physical therapy including temperature application and traction(Arm;Physical Therapy)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject who has been diagnosed with intervertebral disc herniation or degenerative stenosis (a person who has been diagnosed in the past or has been diagnosed upon obtaining consent)
  • Adult men and women over 19 years of age
  • Body mass index (BMI) 18.5 over to less than 30

Exclusion criteria

  • Subject with fibromyalgia, dystonia, and epilepsy
  • Subject with sensory impairment
  • Subject with physical irritation-induced skin lesions such as fever and compression (dermatosis, compression urticaria, choline urticaria, fever urticaria, etc.)

Treatment and study plan

Ceragem Master V6 Traction

Device

Ceragem Master V6 Traction for L2~L3

Physical therapy with standard traction device

Device

Physical therapy with standard traction device

Primary outcomes

  1. Anterior and posterior distance changes of L2-S1 intervertebral disc

    Time frame: Immediately after application

    Anterior and posterior distance changes of L2-S1 intervertebral disc are evaluated through X-Ray immediately after application of medical device compared to baseline

Secondary outcomes

  1. Ratio of L2-S1 Anterior/posterior intervertebral distance

    Time frame: Immediately after application

    Ratio of L2-S1 Anterior/posterior intervertebral distance evaluated by X-Ray immediately after application of medical device compared to baseline (A/P ratio)

  2. Changes in lower extremity radiation pain

    Time frame: Immediately after application

    Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline

  3. Changes in the range of waist movement

    Time frame: Immediately after application

    Changes in the range of waist movement evaluated by the Schober test immediately after one application of medical device compare to baseline

  4. Change in the angle evaluated by the SLR test

    Time frame: Immediately after application

    Change in the angle evaluated by the Straight Leg Rasing test (SLR test) modified immediately after the application of the medical device compared to the baseline

Sponsors and collaborators

Lead sponsor

Ceragem Clinical Inc.

Industry

Registry information

Official study title

A Single-center, Open-label, Randomized, Parallel-group, Standard Therapy Controlled, Equivalence Clinical Trials to Evaluate the Efficacy and Safety of Structural Changes in the Spine to Determine the Traction Effect of an Investigational Device, Ceragem Master V6 (CGM MB-1701) Use in Patients With Lumber Disc Herniation & Degenerative Spinal Stenosis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2022
Registry last updated
Feb 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.