NCT02597244

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

1.6 years

First QC Date

October 6, 2015

Last Update Submit

November 3, 2015

Conditions

Spinal Stenosis

Keywords

Lumbar foraminal stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • NRS score

    8, 12 weeks after intervention

  • Oswestry disability index(ODI)

    4, 8 and 12 weeks after intervention

  • 5-point satisfaction scale

    4, 8 and 12 weeks

  • Any adverse events

    Throughout the study period (up to 12 weeks)

  • Roland-Morris Disability Questionnaire(RDQ)

    4, 8 and 12 weeks after intervention

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Device: Percutaneous Extraforaminotomy

Interventions

Percutaneous ExtraforaminotomyDEVICE

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

Treatment group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related 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.

    PMID: 16858467RESULT

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Sangchul Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangchul Lee, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 6, 2015

First Posted

November 5, 2015

Study Start

June 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

KR(1)