Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol

Conditions
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Spinal Stenosis Lumbar

Intervention / Treatment
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* Procedure: Williams flexion protocol
* Procedure: Focused spinal stenosis rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lumbar spinal stenosis with neurogenic claudication Symptoms present for at least 3 months Moderate to severe acquired or congenital LSS based on radiological evaluation Lumbar MRI obtained within the past 12 months prior to initial physical therapy visit 40 years of age or older Body mass index less than or equal to 35 Can tolerate a 6-min treadmill test Willing to comply with home exercises as prescribed Exclusion Criteria: Acute disc herniation Grade 3 or greater spondylolisthesis Rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis) Active spinal compression fractures Knee surgery in the previous 6 months (e.g., total knee arthroplasty) Previous spinal fusion Absence of pedal pulses Inflammation/infectious process Myelopathy Psychiatric disorder preventing informed consent or participation in assigned physical therapy sessions Patients with pending litigation or workers compensation

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: Standard<br> | Procedure: Williams flexion protocol<br>* The Williams flexion protocol group will participate in 15 treatment sessions.<br>|
| Experimental: Individualized<br> | Procedure: Focused spinal stenosis rehabilitation<br>* The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |