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Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for this research study. These patients don't need immediate surgery for this problem. Treatment of this kind of back pain with spinal stenosis usually includes physical therapy exercises and steroid injections. Both treatments are usually helpful in patients with back pain with spinal stenosis. However, physicians and other healthcare providers don't know which treatment is better to give first. The purpose of this research is to answer that question. Patients enrolled in this study will receive both treatments: physical therapy (PT) and a steroid injection ("shot"). However, patients may get the shot first followed by PT, or they may have PT first, followed by the shot. Their time in this study will last up to 6 months, and there will be five outcome measurements (via visits or telephone). All study visits will take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about 120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization computer program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy first | Active Comparator | patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection |
|
| lumbar epidural steroid first | Active Comparator | lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical therapy | Other | physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry disability Index | measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| visual analog scale | measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year | 1 year |
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Inclusion Criteria: chronic low back pain (at least 3 months in duration), a Visual Analogue Scale (VAS) greater than 30 (on a 100 point scale), between the ages of 18 to 80 years, either without radiating leg pain (below the knees) or with low back and/or buttock pain greater than leg pain (in which case the VAS for leg pain must be 20 or less), ability to read English and complete the assessment instruments, and diagnosis of lumbar spinal stenosis by a board certified radiologist or a board certified physiatrist either by magnetic resonance imaging (MRI) or computed-tomography (CT) that has previously been done as part of a normal course of patients medical treatment. All underlying etiology or diagnoses that are the source for lumbar spinal stenosis will be recorded (e.g. spondylolisthesis, herniated or degenerative discs, spondylosis).
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Monfared, MD | Emory University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Veterans Affairs Medical Center | Decatur | Georgia | 30033 | United States |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| lumbar interlaminar epidural steroid injection | Procedure | single lumbar interlaminar epidural steroid injection |
|
| epidural steroid injection | Drug | Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume) |
|