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Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial
This study is currently Recruiting
August 2009 By Franklin Pierce University
First Recieved on November 5, 2008
Last Updated on July 13, 2011
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 significant healthcare costs affecting both the individual and society. It has
been reported that patients with LSS over the age of 65 are more likely to undergo spinal
surgery than any other condition with an estimated total annual inpatient expense of one
billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore
operative morbidity and mortality are a particular concern. Functional benefit derived
from conservative treatment may increase the health and quality of life for individuals
suffering from LSS and avoid or delay the need for surgery in some subjects. As the
population continues to age, identifying effective non-surgical treatment options for older
patients with LSS is an important research priority. Ultimately, the information gained
from this study will help fill a significant void in medical literature regarding
non-surgical options for this patient population.
||Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Epidural steroid injection and physical therapy:Other|
|Epidural steroid injection:Other|
|Other:Epidural steroid injection plus physical therapy|
Patients in the ESI+PT Group will be treated additionally with a physical therapy program emphasizing lumbar flexion exercises, aerobic and strength/ conditioning exercises, and manual physical therapy as well as receiving up to 3 epidural steroid injection(s) and educational support using The Back Book.
|Other:Epidural steroid injection|
Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.
|Ages Eligible for Study:||50 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. 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.
2. Chief complaint of pain in the low back, buttock, and/or lower extremity. The
patient must have LE symptoms consistent with neurogenic claudiation.
3. Patient-reported inability to walk greater than ? mile due to lower extremity pain
4. Rates sitting as a better position with respect to symptom severity compared to
standing or walking.
5. Consent of the patient to undergo education, epidural steroid injection(s), and
attend specified physical therapy sessions.
6. Individuals with no language barrier, that are cooperative, have transportation to
the Spine Center, and who sign an informed consent form.
7. Age greater than or equal to 50 years.
1. Patients with organic brain syndrome or dementia.
2. Severe vascular, pulmonary or coronary artery disease which limits ambulation.
3. Recent myocardial infarction (within last 6 months).
4. Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
5. Previous spinal surgery that included fusion of two or more vertebrae.
6. Severe osteoporosis as defined by multiple compression fractures or a fracture at the
same level as the stenosis.
7. Metastatic cancer.
8. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.