Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis
Primary Purpose
Spinal Stenosis Lumbar
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Williams flexion protocol
Focused spinal stenosis rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis Lumbar
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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard
Individualized
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain
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
Quality of life will be measured using the PROMIS Physical Function 10a Questionnaire.
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.
Physical ability
Physical ability will be assessed upon exams that measure balance, hip abductor strength, range of motion, etc.
Full Information
NCT ID
NCT02982291
First Posted
December 1, 2016
Last Updated
February 1, 2018
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT02982291
Brief Title
Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis
Official Title
Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty recruiting patients
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis Lumbar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
Active Comparator
Arm Title
Individualized
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Williams flexion protocol
Intervention Description
The Williams flexion protocol group will participate in 15 treatment sessions.
Intervention Type
Procedure
Intervention Name(s)
Focused spinal stenosis rehabilitation
Intervention Description
The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.
Primary Outcome Measure Information:
Title
Change in functional ability
Description
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.
Time Frame
Up to 1 year after initial physical therapy visit
Secondary Outcome Measure Information:
Title
Pain
Description
Pain will be measured by the Numerical Pain Rating Scale, on a 0-10 scale, where 0=no pain and 10=worst pain.
Time Frame
Up to 1 year after initial physical therapy visit
Title
Quality of life
Description
Quality of life will be measured using the PROMIS Physical Function 10a Questionnaire.
Time Frame
Up to 1 year after initial physical therapy visit
Title
Tolerance to exercise
Description
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.
Time Frame
Up to 1 year after initial physical therapy visit
Title
Physical ability
Description
Physical ability will be assessed upon exams that measure balance, hip abductor strength, range of motion, etc.
Time Frame
Up to 1 year after initial physical therapy visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Turner
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis
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