Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

NCT02982291 | Withdrawn

• 1 other identifier: 2015-182
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis Lumbar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain

  Up to 1 year after initial physical therapy visit

• Quality of life

  Up to 1 year after initial physical therapy visit

• Tolerance to exercise

  Up to 1 year after initial physical therapy visit

• Physical ability

  Up to 1 year after initial physical therapy visit

Study Arms (2)

Standard

ACTIVE COMPARATOR

Procedure: Williams flexion protocol

Individualized

EXPERIMENTAL

Procedure: Focused spinal stenosis rehabilitation

Interventions

Williams flexion protocol PROCEDURE

The Williams flexion protocol group will participate in 15 treatment sessions.

Standard

Focused spinal stenosis rehabilitation PROCEDURE

The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.

Individualized

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Officials

• Robert Turner

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: May 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (1)