Effectiveness of Percutaneous Foraminotomy

Seoul National University Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Stenosis

Interventions

Percutaneous ExtraforaminotomyDEVICE

percutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 4 weeks after intervention

Secondary Outcomes

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

Time frame: 8, 12 weeks after intervention

Oswestry disability index(ODI)

A change of ODI over periods of time after intervention (12 weeks)

Time frame: 4, 8 and 12 weeks after intervention

5-point satisfaction scale

Patient satisfaction with treatment at 4, 8, \& 12 weeks

Time frame: 4, 8 and 12 weeks

Any adverse events

Time frame: 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)

Time frame: 4, 8 and 12 weeks after intervention

Central Contacts

Sangchul Lee, MD, PhD

CONTACT

+82-2-2072-2248 pain8275@gmail.com

Data from ClinicalTrials.gov

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