CETIC-I (CEra Traction Improves Cervical Kyphosis -I)
A Prospective, Randomized, Single-blinded, Sham Device Controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 in Subjects With Cervical Kyphosis and Posterior Neck Pain.
1 other identifier
interventional
30
1 country
1
Brief Summary
The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior Neck Pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedStudy Start
First participant enrolled
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2024
CompletedFebruary 9, 2026
February 1, 2026
1.2 years
July 19, 2022
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change of cervical lordosis
Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline.
up to 16 weeks
Secondary Outcomes (3)
Change of cervical lordosis at 2nd interim analysis
up to 16 weeks
Cervical vestibular angle increase more than 10 degrees
up to 16 weeks
Anteroposterior (T1) slope average change
up to 16 weeks
Study Arms (2)
CGM_MB_1701 treatment
EXPERIMENTALSubjects will be treated with the study device for about 36 minutes.
Sham (CGM MB1701C) treament
SHAM COMPARATORSubjects will be treated with the Sham device for about 36 minutes.
Interventions
This is a pre-approved motorized traction device.
It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized.
Eligibility Criteria
You may qualify if:
- Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
- Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
- BMI betweeen 18.5 and 30
- Chronic neck pain NRS 4 or higher lasting more than 3 months
You may not qualify if:
- Secondary spondylosis
- A tumor of the spine
- Inflammatory spondylitis
- Myelopathy
- Multiple adjacent radiculopathies and others
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Yangsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Il Shin, MD
Pusan National University Yangsan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 21, 2022
Study Start
May 9, 2023
Primary Completion
July 26, 2024
Study Completion
July 26, 2024
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share