Effectiveness of Percutaneous Foraminotomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Stenosis
• Intervention / Treatment: Device: Percutaneous Extraforaminotomy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sangchul Lee, MD, PhD; Phone Number: +82-2-2072-2248; Email: pain8275@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sangchul Lee, MD, PhD; Phone Number: +82-2-2072-2248; Email: pain8275@gmail.com
    • Sub-Investigator: JeeYoun Moon, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: BioSpine Co., Ltd.
• Investigators: Principal Investigator: Sangchul Lee, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ANTICIPATED): January 1, 2016
• Study Completion (ANTICIPATED): January 1, 2016

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (ESTIMATE): November 5, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Lumbar foraminal stenosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 0620141940