Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

Spinal Stenosis Lumbar Clinical Trial

Official title:

Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02982291
• Other study ID #: 2015-182
• Status: Withdrawn
• Phase: N/A
• First received: December 1, 2016
• Last updated: February 1, 2018
• Start date: May 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2018
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Procedure:
• Williams flexion protocol
The Williams flexion protocol group will participate in 15 treatment sessions.
• Focused spinal stenosis rehabilitation
The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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