Effectiveness of Percutaneous Foraminotomy

Not Applicable

• Conditions: Spinal Stenosis
• Interventions: Device: Percutaneous Extraforaminotomy

• Registration Number: NCT02597244
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-10-06
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-03
• Last Update Submitted: 2015-11-03
• Study First Posted: 2015-11-05
• Last Update Posted: 2015-11-05
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Percutaneous Extraforaminotomy	Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
5-point satisfaction scale	4, 8 and 12 weeks	Patient satisfaction with treatment at 4, 8, \& 12 weeks
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)
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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of