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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traction treatment | Experimental | About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke |
|
| Physical Therapy | Active Comparator | About 40 minutes standard physical therapy including temperature application and traction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceragem Master V6 Traction | Device | Ceragem Master V6 Traction for L2~L3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately after application |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Immediately after application |
| Changes in lower extremity radiation pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Soon Yoon | Presbyterian Medical Cente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presbyterian Medical Center | Jeonju | South Korea |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physical therapy with standard traction device |
| Device |
Physical therapy with standard traction device |
|
Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline |
| 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 | 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 | Immediately after application |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |