CETIS-I (CEra Traction Improves Spine-I)

Ceragem Clinical

Status: Completed

Conditions: Spine Traction; Degenerative Spinal Stenosis; Lumbar Disc Herniation

Treatments: Device: Ceragem Master V6 Traction; Device: Physical therapy with standard traction device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05549596

CC_MV6_208

Details and patient eligibility

About

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.

Full 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)

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Traction treatment

Experimental group

Description:

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

Treatment:

Device: Ceragem Master V6 Traction

Physical Therapy

Active Comparator group

Description:

About 40 minutes standard physical therapy including temperature application and traction

Treatment:

Device: Physical therapy with standard traction device