Status:
COMPLETED
Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis
Lead Sponsor:
Franklin Pierce University
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing aging population. People with LSS often have a substantial physical and psychosocial burden as well as signif...
Eligibility Criteria
Inclusion
- Lumbar spinal stenosis unidentified by MRI or CT scan and interpreted by a radiologist independent of the study. The criteria of Boden et al will be used to define LSS on MRI: non-discogenic loss of signal in the epidural fat with compression of neural tissues.
- Chief complaint of pain in the low back, buttock, and/or lower extremity. The patient must have LE symptoms consistent with neurogenic claudiation.
- Patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping.
- Rates sitting as a better position with respect to symptom severity compared to standing or walking.
- Consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions.
- Individuals with no language barrier, that are cooperative, have transportation to the Spine Center, and who sign an informed consent form.
- Age greater than or equal to 50 years.
Exclusion
- Patients with organic brain syndrome or dementia.
- Severe vascular, pulmonary or coronary artery disease which limits ambulation.
- Recent myocardial infarction (within last 6 months).
- Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
- Previous spinal surgery that included fusion of two or more vertebrae.
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00786981
Start Date
April 1 2009
End Date
December 1 2018
Last Update
July 31 2019
Active Locations (4)
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1
Colorado University
Denver, Colorado, United States
2
Illinois Neurological Institute at OSF
Peoria, Illinois, United States, 61637
3
Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States, 39564
4
Hawkins Foundation
Greenville, South Carolina, United States, 29615