Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Stenosis Lumbar
• Intervention / Treatment: Procedure: Williams flexion protocol; Procedure: Focused spinal stenosis rehabilitation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard	Procedure: Williams flexion protocol; The Williams flexion protocol group will participate in 15 treatment sessions.
Experimental: Individualized	Procedure: Focused spinal stenosis rehabilitation; The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Robert Turner, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 2015-182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No