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Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Withdrawn

Conditions

Spinal Stenosis Lumbar

Treatments

Procedure: Focused spinal stenosis rehabilitation
Procedure: Williams flexion protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT02982291
2015-182

Details and patient eligibility

About

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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Standard
Active Comparator group
Treatment:
Procedure: Williams flexion protocol
Individualized
Experimental group
Treatment:
Procedure: Focused spinal stenosis rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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