CETIS-I (CEra Traction Improves Spine-I)

Ceragem Clinical Inc.60 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lumbar Disc Herniation Degenerative Spinal Stenosis Spine Traction

Interventions

Ceragem Master V6 TractionDEVICE

Ceragem Master V6 Traction for L2\~L3

Physical therapy with standard traction deviceDEVICE

Physical therapy with standard traction device

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Presbyterian Medical Center

Jeonju, South Korea

Outcomes

Primary Outcomes

Anterior and posterior distance changes of L2-S1 intervertebral disc

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