CETIS-I (CEra Traction Improves Spine-I)

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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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

Conditions
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Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction

Intervention / Treatment
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* Device: Ceragem Master V6 Traction
* Device: Physical therapy with standard traction device


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traction treatment<br>About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke | Device: Ceragem Master V6 Traction<br>* Ceragem Master V6 Traction for L2 L3<br>|
| Active Comparator: Physical Therapy<br>About 40 minutes standard physical therapy including temperature application and traction | Device: Physical therapy with standard traction device<br>* Physical therapy with standard traction device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Immediately after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of L2-S1 Anterior/posterior intervertebral distance | Ratio of L2-S1 Anterior/posterior intervertebral distance evaluated by X-Ray immediately after application of medical device compared to baseline (A/P ratio) | Immediately after application | 
| Changes in lower extremity radiation pain | Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline | Immediately after application | 
| Changes in the range of waist movement | Changes in the range of waist movement evaluated by the Schober test immediately after one application of medical device compare to baseline | Immediately after application | 
| Change in the angle evaluated by the SLR test | 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 | Immediately after application |