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| Name | Class |
|---|---|
| BioSpine Co., Ltd. | INDUSTRY |
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Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea), was performed in patients who did not show improvement lasting more than 1 month after diagnostic conventional fluoroscopically guided transforaminal epidural block with local anesthetic and steroid.
Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the procedure.
Percutaneous Extraforaminotomy with Transforaminal Adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Extraforaminotomy | Device | percutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| NRS score | A comparison of the mean difference in the change of NRS scores of their leg pain from entry to the scores at 4-week | 4 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| NRS score | A comparison of the mean difference in the change of NRS scores of their leg pain from entry to the scores at 8, 12-weeks after intervention | 8, 12 weeks after intervention |
| Oswestry disability index(ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sangchul Lee, MD, PhD | Contact | +82-2-2072-2248 | pain8275@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sangchul Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16858467 | Result | Cooper G, Lutz GE, Boachie-Adjei O, Lin J. Effectiveness of transforaminal epidural steroid injections in patients with degenerative lumbar scoliotic stenosis and radiculopathy. Pain Physician. 2004 Jul;7(3):311-7. |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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A change of ODI over periods of time after intervention (12 weeks)
| 4, 8 and 12 weeks after intervention |
| 5-point satisfaction scale | Patient satisfaction with treatment at 4, 8, & 12 weeks | 4, 8 and 12 weeks |
| Any adverse events | Throughout the study period (up to 12 weeks) |
| Roland-Morris Disability Questionnaire(RDQ) | A change of RDQ change over periods of time after intervention (12 weeks) | 4, 8 and 12 weeks after intervention |