Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis
- Conditions
- Spinal Stenosis Lumbar
- Interventions
- Procedure: Focused spinal stenosis rehabilitationProcedure: Williams flexion protocol
- Registration Number
- NCT02982291
- Lead Sponsor
- Hospital for Special Surgery, New York
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized Focused spinal stenosis rehabilitation - Standard Williams flexion protocol -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States