Clinical trial NCT02597244: Effectiveness of Percutaneous Foraminotomy
Official title: Effectiveness of Percutaneous Foraminotomy in Patients With Lumbar Foraminal Stenosis: A Prospective, Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Stenosis
Keywords: Lumbar foraminal stenosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: BioSpine Co., Ltd.
First posted: 2015-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: NRS score
timeFrame: 4 weeks after intervention
Secondary outcomes:
measure: NRS score
timeFrame: 8, 12 weeks after intervention
measure: Oswestry disability index(ODI)
timeFrame: 4, 8 and 12 weeks after intervention
measure: 5-point satisfaction scale
timeFrame: 4, 8 and 12 weeks
measure: Any adverse events
timeFrame: Throughout the study period (up to 12 weeks)
measure: Roland-Morris Disability Questionnaire(RDQ)
timeFrame: 4, 8 and 12 weeks after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sangchul Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.