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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02597244
Other study ID # 0620141940
Secondary ID
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


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
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