Spinal Stenosis Lumbar
Conditions
Brief summary
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.
Interventions
PROCEDUREWilliams flexion protocol
The Williams flexion protocol group will participate in 15 treatment sessions.
PROCEDUREFocused spinal stenosis rehabilitation
The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional ability | Up to 1 year after initial physical therapy visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Up to 1 year after initial physical therapy visit | Pain will be measured by the Numerical Pain Rating Scale, on a 0-10 scale, where 0=no pain and 10=worst pain. |
| Quality of life | Up to 1 year after initial physical therapy visit | Quality of life will be measured using the PROMIS Physical Function 10a Questionnaire. |
| Tolerance to exercise | Up to 1 year after initial physical therapy visit | 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. |
| Physical ability | Up to 1 year after initial physical therapy visit | Physical ability will be assessed upon exams that measure balance, hip abductor strength, range of motion, etc. |
Countries
United States
Outcome results
None listed