CompletedNot Applicable

CETIC-I (CEra Traction Improves Cervical Kyphosis -I)

South Korea30 participantsStarted 2023-05-09

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Secondary spondylosis
✕. A tumor of the spine
✕. Inflammatory spondylitis
✕. Myelopathy
✕. Multiple adjacent radiculopathies and others

What they're measuring

Mean change of cervical lordosis

Timeframe: up to 16 weeks

Trial details

NCT IDNCT05469295

SponsorCeragem Clinical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-26

View on ClinicalTrials.gov More Cervical Kyphosis trials