Spinal Stenosis Clinical Trial
Official title:
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | BioSpine Co., Ltd. |
Korea, Republic of,
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
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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