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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural steroid injection and physical therapy | Other |
| |
| Epidural steroid injection | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural steroid injection plus physical therapy | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado University | Denver | Colorado | United States | |||
| Illinois Neurological Institute at OSF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30703349 | Derived | Hammerich A, Whitman J, Mintken P, Denninger T, Akuthota V, Sawyer EE, Hofmann M, Childs JD, Cleland J. Effectiveness of Physical Therapy Combined With Epidural Steroid Injection for Individuals With Lumbar Spinal Stenosis: A Randomized Parallel-Group Trial. Arch Phys Med Rehabil. 2019 May;100(5):797-810. doi: 10.1016/j.apmr.2018.12.035. Epub 2019 Jan 29. |
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|
| Epidural steroid injection | Other | Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician. |
|
| 10 weeks, 6 months, 12 months |
| Change in patient satisfaction | 10 weeks, 6 months, 12 months |
| Peoria |
| Illinois |
| 61637 |
| United States |
| Keesler Air Force Base | Keesler Air Force Base | Mississippi | 39564 | United States |
| Hawkins Foundation | Greenville | South Carolina | 29615 | United States |
| 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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