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Difficulty recruiting patients
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Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. A Williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. However, few studies have been done to validate the efficacy of this protocol. A more focused treatment protocol may be more efficacious. Patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). The sessions will take place over the course of 6 months. Outcomes will be assessed using validated questionnaires and physical function tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator |
| |
| Individualized | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Williams flexion protocol | Procedure | The Williams flexion protocol group will participate in 15 treatment sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional ability | Change in functional ability will be assessed using the Oswestry Disability Index. The minimum clinically important difference of the ODI has been documented in the literature as a 13-point change. | Up to 1 year after initial physical therapy visit |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain will be measured by the Numerical Pain Rating Scale, on a 0-10 scale, where 0=no pain and 10=worst pain. | Up to 1 year after initial physical therapy visit |
| Quality of life | Quality of life will be measured using the PROMIS Physical Function 10a Questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Turner | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| Focused spinal stenosis rehabilitation | Procedure | The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions. |
|
| Up to 1 year after initial physical therapy visit |
| Tolerance to exercise | The Timed Treadmill Test, which requires patients to walk on a treadmill at 1.2 miles per hour and a 1% grade and report when they begin experiencing typical exercise-induced symptoms, will be used. | Up to 1 year after initial physical therapy visit |
| Physical ability | Physical ability will be assessed upon exams that measure balance, hip abductor strength, range of motion, etc. | Up to 1 year after initial physical therapy visit |