Lumbar Spinal Stenosis
Conditions
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 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.
Interventions
OTHEREpidural 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.
Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.
Sponsors
University of Colorado, Denver
Franklin Pierce University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW). | 10 weeks, 6 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in patient-reported pain | 10 weeks, 6 months, 12 months |
| Change in Functional Limitations | 10 weeks, 6 months, 12 months |
| Change in psychosocial evaluation | 10 weeks, 6 months, 12 months |
| Change in patient satisfaction | 10 weeks, 6 months, 12 months |
Countries
United States
Outcome results
None listed