Status:
COMPLETED
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Kaiser Permanente
University of California, San Francisco
Conditions:
Spinal Stenosis
Low Back Pain
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 cl...
Detailed Description
Lumbar spinal stenosis is one of the most common causes of low back pain in the elderly and can lead to significant disability. The symptoms of spinal stenosis range from low back pain to neurogenic c...
Eligibility Criteria
Inclusion
- Pain in the low back, buttock, and/or lower extremity (pain NRS\>=5) with standing, walking and/or spinal extension (buttock/leg\>back pain).
- Modified Roland-Morris score of at least 7.
- Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan.
- Lower extremity symptoms consistent with neurogenic claudication.
- Must be able to read English and complete the assessment instruments.
- Age 50 or older.
Exclusion
- Cognitive impairment that renders the patient unable to give informed consent or provide accurate data.
- 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
- Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months).
- Spinal instability requiring surgical fusion.
- Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
- Metastatic cancer.
- Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Concordant pain with internal rotation of the hip (or known hip joint pathology).
- Active local or systemic infection.
- Abnormal coagulation.
- Allergy to local anesthetic, steroid or contrast.
- Previous lumbar spine surgery.
- Epidural steroid injection within previous 6 months.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01238536
Start Date
April 1 2011
End Date
September 1 2015
Last Update
December 13 2017
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaiser Permanente Northern California
Redwood City, California, United States, 94063
2
Kaiser Permanente Northern California
Roseville, California, United States, 95661
3
University of Colorado
Denver, Colorado, United States, 80045
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02467