CETIS-I (CEra Traction Improves Spine-I)

NCT05549596 | Completed

• 1 other identifier: CC_MV6_208
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation; Degenerative Spinal Stenosis; Spine Traction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ratio of L2-S1 Anterior/posterior intervertebral distance

  Immediately after application

• Changes in lower extremity radiation pain

  Immediately after application

• Changes in the range of waist movement

  Immediately after application

• Change in the angle evaluated by the SLR test

  Immediately after application

Study Arms (2)

Traction treatment

EXPERIMENTAL

About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke

Device: Ceragem Master V6 Traction

Physical Therapy

ACTIVE COMPARATOR

About 40 minutes standard physical therapy including temperature application and traction

Device: Physical therapy with standard traction device

Interventions

Ceragem Master V6 Traction DEVICE

Ceragem Master V6 Traction for L2\~L3

Traction treatment

Physical therapy with standard traction device DEVICE

Physical therapy with standard traction device

Physical Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ceragem Clinical Inc.: lead

Study Sites (1)

Presbyterian Medical Center

Jeonju, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Yong Soon Yoon

  Presbyterian Medical Cente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 22, 2022
• Study Start: January 3, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)