Effectiveness of Percutaneous Foraminotomy

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597244
• Other study ID #: 0620141940
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: November 3, 2015
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: Sangchul Lee, MD, PhD
• Phone: +82-2-2072-2248
• Email: pain8275[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	BioSpine Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Cooper G, Lutz GE, Boachie-Adjei O, Lin J. Effectiveness of transforaminal epidural steroid injections in patients with degenerative lumbar scoliotic stenosis and radiculopathy. Pain Physician. 2004 Jul;7(3):311-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Oswestry disability index(ODI)	A change of ODI over periods of time after intervention (12 weeks)	4, 8 and 12 weeks after intervention	No
Secondary	5-point satisfaction scale	Patient satisfaction with treatment at 4, 8, & 12 weeks	4, 8 and 12 weeks	No
Secondary	Any adverse events		Throughout the study period (up to 12 weeks)	Yes
Secondary	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	No