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Effectiveness of Percutaneous Foraminotomy

Primary Purpose

Spinal Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous Extraforaminotomy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring Lumbar foraminal stenosis

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Oswestry disability index(ODI)
A change of ODI over periods of time after intervention (12 weeks)
5-point satisfaction scale
Patient satisfaction with treatment at 4, 8, & 12 weeks
Any adverse events
Roland-Morris Disability Questionnaire(RDQ)
A change of RDQ change over periods of time after intervention (12 weeks)

Full Information

First Posted
October 6, 2015
Last Updated
November 3, 2015
Sponsor
Seoul National University Hospital
Collaborators
BioSpine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02597244
Brief Title
Effectiveness of Percutaneous Foraminotomy
Official Title
Effectiveness of Percutaneous Foraminotomy in Patients With Lumbar Foraminal Stenosis: A Prospective, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
BioSpine Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
Lumbar foraminal stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea)
Intervention Type
Device
Intervention Name(s)
Percutaneous Extraforaminotomy
Intervention Description
percutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy
Primary Outcome Measure Information:
Title
NRS score
Description
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 Outcome Measure Information:
Title
NRS score
Description
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
Title
Oswestry disability index(ODI)
Description
A change of ODI over periods of time after intervention (12 weeks)
Time Frame
4, 8 and 12 weeks after intervention
Title
5-point satisfaction scale
Description
Patient satisfaction with treatment at 4, 8, & 12 weeks
Time Frame
4, 8 and 12 weeks
Title
Any adverse events
Time Frame
Throughout the study period (up to 12 weeks)
Title
Roland-Morris Disability Questionnaire(RDQ)
Description
A change of RDQ change over periods of time after intervention (12 weeks)
Time Frame
4, 8 and 12 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Acute back or leg pain Sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes Patients with a history of prior spine surgery Allergic response to steroid or contrast dye Bleeding diathesis or over coagulopathy Patients with bilateral radiculopathy or spinal stenosis at more than 3 levels
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangchul Lee, MD, PhD
Phone
+82-2-2072-2248
Email
pain8275@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangchul Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangchul Lee, MD, PhD
Phone
+82-2-2072-2248
Email
pain8275@gmail.com
First Name & Middle Initial & Last Name & Degree
Sangchul Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
JeeYoun Moon, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16858467
Citation
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.
Results Reference
result

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Effectiveness of Percutaneous Foraminotomy

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