Degenerative Spinal Stenosis, Lumbar Disc Herniation, Spine Traction
Conditions
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)
Interventions
DEVICECeragem Master V6 Traction
Ceragem Master V6 Traction for L2\~L3
DEVICEPhysical therapy with standard traction device
Physical therapy with standard traction device
Sponsors
Ceragem Clinical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYong Soon Yoon
Presbyterian Medical Cente
Outcome results
None listed