Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Other: Epidural steroid injection plus physical therapy
* Other: Epidural steroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Epidural steroid injection and physical therapy<br> | Other: Epidural steroid injection plus physical therapy<br>* 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.<br>|
| Other: Epidural steroid injection<br> | Other: Epidural steroid injection<br>* Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |