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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Ceragem Master V6 Traction for L2\~L3
Physical therapy with standard traction device
Presbyterian Medical Center
Jeonju, South Korea
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
Time frame: Immediately after application
Ratio of L2-S1 Anterior/posterior intervertebral distance
Ratio of L2-S1 Anterior/posterior intervertebral distance evaluated by X-Ray immediately after application of medical device compared to baseline (A/P ratio)
Time frame: Immediately after application
Changes in lower extremity radiation pain
Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline
Time frame: Immediately after application
Changes in the range of waist movement
Changes in the range of waist movement evaluated by the Schober test immediately after one application of medical device compare to baseline
Time frame: Immediately after application
Change in the angle evaluated by the SLR test
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
Time frame: Immediately after application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.