Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 2/9/2018 |
| Start Date: | April 2009 |
| End Date: | December 2018 |
Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial
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.
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.
Inclusion Criteria:
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 ¼ mile due to lower extremity pain
and/or cramping.
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.
Exclusion Criteria:
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.
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