Effectiveness of Percutaneous Foraminotomy

Seoul National University

Status: Unknown

Conditions: Spinal Stenosis

Treatments: Device: Percutaneous Extraforaminotomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02597244

0620141940

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment group

Experimental group

Description:

Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea)

Treatment:

Device: Percutaneous Extraforaminotomy