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Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 65 and Older
This study is currently Recruiting
October 2011 By University of Washington
First Recieved on November 8, 2010
Last Updated on October 27, 2011
The broad, long-term objective of this research protocol is to improve the quality of life
for patients suffering from lumbar spinal stenosis. This objective will be met by examining
the safety and clinical efficacy of epidural steroid injections for treatment of pain
associated with lumbar spinal stenosis. This prospective, randomized, double-blind
controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid
injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone
in older adults with lumbar spinal stenosis.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Epidural Steroid with local anesthetic injection:Experimental|
|Epidural local anesthetic injection:Active Comparator|
|Procedure:Epidural steroid with local anesthetic injection|
Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.
|Procedure:Epidural local anesthetic injection|
Epidural injectate will be 2cc of 1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
|Ages Eligible for Study:||50 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Pain in the low back, buttock, and/or lower extremity (pain NRS>5) with standing,
walking and/or spinal extension (buttock/leg>back pain).
2. Modified Roland-Morris score of at least 7.
3. Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified
by MRI or CT scan.
4. Lower extremity symptoms consistent with neurogenic claudication.
5. Must be able to read English and complete the assessment instruments.
6. Age 50 or older.
1. Cognitive impairment that renders the patient unable to give informed consent or
provide accurate data.
2. Clinical co-morbidities that could interfere with the collection of data concerning
pain and function.
Known dx of fibromyalgia, chronic widespread pain, amputees, parkinsons, head injury,
dementia, stroke, other neurologic conditions Collect date about cervical spinal
stenosis, painful peripheral neuropathy, EMGs
3. Severe vascular, pulmonary or coronary artery disease that limits ambulation
including recent myocardial infarction (within 6 months).
4. Spondylolisthesis requiring surgical fusion (i.e. greater than 5mm of slippage).
5. Severe osteoporosis as defined by multiple compression fractures or a fracture at the
same level as the stenosis.
6. Metastatic cancer.
7. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
8. Possible pregnancy or other reason that precludes the use of fluoroscopy.
9. Concordant pain with internal rotation of the hip (or known hip joint pathology).
10. Active local or systemic infection.
11. Abnormal coagulation.
12. Allergy to local anesthetic, steroid or contrast.
13. Previous lumbar spine fusion surgery, X-STOP or lumbar decompression surgery.
14. Lumbar epidural steroid injection within previous 6 months.
- Investigator: Janna L Friedly, MD - Principal Investigator - University of Washington
- Kaiser Permanente Northern California
Redwood City, California 94063 United States
- Kaiser Permanente Northern California
Roseville, California 95661 United States
- University of Colorado
Denver, Colorado 80045 United States
- Brigham and Women's Hospital
Boston, Massachusetts 02467 United States
- Henry Ford Hospital
Detroit, Michigan 48202 United States
- Mayo Clinic
Rochester, Minnesota 55905 United States
- Harborview Medical Center, University of Washington
Seattle, Washington 98104 United States