Spinal Stenosis
Conditions
Keywords
Lumbar foraminal stenosis
Brief summary
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.
Detailed description
Percutaneous Extraforaminotomy with Transforaminal Adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.
Interventions
DEVICEPercutaneous Extraforaminotomy
percutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy
Sponsors
BioSpine Co., Ltd.
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* radicular pain with positive provocation factors \> 3 months * Radicular pain at L4 or L5 * Presence of dominant side when bilateral symptom present * Positive provocation factors: leg symptoms elicited or aggravated by walking but relieved by sitting down * Not appropriate relief of pain routinely conservative treatment (physiotherapy, exercise, analgesic medication, epidural steroid injection) \> 3 months * Magnetic resonance imaging(MRI) : Foraminal stenosis of Grade 1-3 (foraminal herniated intervertebral disc(HIVD) with mild to severe degree of foraminal stenosis according to AJR:194, April 2010 by Lee, et. Al) * Subjects who signed for the consent form
Exclusion criteria
1. Acute back or leg pain 2. Sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes 3. Patients with a history of prior spine surgery 4. Allergic response to steroid or contrast dye 5. Bleeding diathesis or over coagulopathy 6. Patients with bilateral radiculopathy or spinal stenosis at more than 3 levels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS score | 4 weeks after intervention | A comparison of the mean difference in the change of NRS scores of their leg pain from entry to the scores at 4-week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS score | 8, 12 weeks after intervention | 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 |
| Oswestry disability index(ODI) | 4, 8 and 12 weeks after intervention | A change of ODI over periods of time after intervention (12 weeks) |
| 5-point satisfaction scale | 4, 8 and 12 weeks | Patient satisfaction with treatment at 4, 8, & 12 weeks |
| Any adverse events | Throughout the study period (up to 12 weeks) | — |
| Roland-Morris Disability Questionnaire(RDQ) | 4, 8 and 12 weeks after intervention | A change of RDQ change over periods of time after intervention (12 weeks) |
Countries
South Korea
Contacts
Primary ContactSangchul Lee, MD, PhD
Outcome results
None listed