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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06290908 -
RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
|
||
Withdrawn |
NCT03223701 -
Efficacy of Using Solum IV and BMC With GFC in TLIF
|
Phase 4 | |
Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
Completed |
NCT02902380 -
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
|
N/A | |
Not yet recruiting |
NCT06024785 -
Vertebropexy - Randomized-controlled Trial
|
N/A | |
Not yet recruiting |
NCT06000319 -
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
|
||
Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
Completed |
NCT02454400 -
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
|
N/A | |
Completed |
NCT01377623 -
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
|
N/A | |
Completed |
NCT00996073 -
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
Phase 2 | |
Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
Completed |
NCT00022776 -
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
|
Phase 3 | |
Completed |
NCT06060821 -
Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
|
||
Recruiting |
NCT04552145 -
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
|
N/A | |
Active, not recruiting |
NCT04379921 -
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
|
N/A | |
Withdrawn |
NCT04315090 -
Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
|
||
Completed |
NCT04591249 -
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
|
N/A | |
Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
Completed |
NCT04193488 -
Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
|
N/A |