CETIS-I (CEra Traction Improves Spine-I)

Not Applicable

Recruiting

• Conditions: Degenerative Spinal Stenosis; Lumbar Disc Herniation; Spine Traction
• Interventions: Device: Ceragem Master V6 Traction; Device: Physical therapy with standard traction device

• Registration Number: NCT05549596
• Lead Sponsor: Ceragem Clinical Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2023-01-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traction treatment	Ceragem Master V6 Traction	About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke
Physical Therapy	Physical therapy with standard traction device	About 40 minutes standard physical therapy including temperature application and traction

Primary Outcome Measures

Name	Time	Method
Anterior and posterior distance changes of L2-S1 intervertebral disc	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 Outcome Measures

Name	Time	Method
Changes in the range of waist movement	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
Ratio of L2-S1 Anterior/posterior intervertebral distance	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)
Changes in lower extremity radiation pain	Immediately after application	Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline
Change in the angle evaluated by the SLR test	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

Trial Locations

Locations (1)

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of