Effectiveness of Percutaneous Foraminotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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Percutaneous Extraforaminotomy with Transforaminal Adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.

Official Title
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Effectiveness of Percutaneous Foraminotomy in Patients With Lumbar Foraminal Stenosis: A Prospective, Pilot Study

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Device: Percutaneous Extraforaminotomy


Participation Criteria
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Eligibility Criteria
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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: Acute back or leg pain Sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes Patients with a history of prior spine surgery Allergic response to steroid or contrast dye Bleeding diathesis or over coagulopathy Patients with bilateral radiculopathy or spinal stenosis at more than 3 levels

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) | Device: Percutaneous Extraforaminotomy<br>* percutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar foraminal stenosis