Clinical trial NCT02982291: Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis
Official title: Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Stenosis Lumbar
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in functional ability
timeFrame: Up to 1 year after initial physical therapy visit
Secondary outcomes:
measure: Pain
timeFrame: Up to 1 year after initial physical therapy visit
measure: Quality of life
timeFrame: Up to 1 year after initial physical therapy visit
measure: Tolerance to exercise
timeFrame: Up to 1 year after initial physical therapy visit
measure: Physical ability
timeFrame: Up to 1 year after initial physical therapy visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Robert Turner
role: PRINCIPAL_INVESTIGATOR
References: