title: Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial.
abstract: BACKGROUND
  Lumbar spinal stenosis is the most common reason for spinal surgery in older adults. Previous studies have shown that surgery is effective for severe cases of stenosis, but many patients with mild to moderate symptoms are not surgical candidates. These patients and their providers are seeking effective non-surgical treatment methods to manage their symptoms; yet there is a paucity of comparative effectiveness research in this area. This knowledge gap has hindered the development of clinical practice guidelines for non-surgical treatment approaches for lumbar spinal stenosis.
  
  
  METHODS
  This study is a prospective randomized controlled clinical trial that will be conducted from November 2013 through October 2016. The sample will consist of 180 older adults (>60 years) who have both an anatomic diagnosis of stenosis confirmed by diagnostic imaging, and signs/symptoms consistent with a clinical diagnosis of lumbar spinal stenosis confirmed by clinical examination. Eligible subjects will be randomized into one of three pragmatic treatment groups: 1) usual medical care; 2) individualized manual therapy and rehabilitative exercise; or 3) community-based group exercise. All subjects will be treated for a 6-week course of care. The primary subjective outcome is the Swiss Spinal Stenosis Questionnaire, a self-reported measure of pain/function. The primary objective outcome is the Self-Paced Walking Test, a measure of walking capacity. The secondary objective outcome will be a measurement of physical activity during activities of daily living, using the SenseWear Armband, a portable device to be worn on the upper arm for one week. The primary analysis will use linear mixed models to compare the main effects of each treatment group on the changes in each outcome measure. Secondary analyses will include a responder analysis by group and an exploratory analysis of potential baseline predictors of treatment outcome.
  
  
  CONCLUSIONS
  Our study should provide evidence that helps to inform patients and providers about the clinical benefits of three non-surgical approaches to the management of lumbar spinal stenosis symptoms.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01943435.
authors.affiliation: School of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Schneider
authors.affiliation: Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Carlo
authors.initials: C
authors.lastname: Ammendolia
authors.affiliation: Clinical Director, Rhode Island Spine Center, Providence, RI, USA ; Department of Family Medicine, Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: Donald
authors.initials: D
authors.lastname: Murphy
authors.affiliation: Departments of Physical Medicine, Family Medicine, and Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Ronald
authors.initials: R
authors.lastname: Glick
authors.affiliation: School of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Sara
authors.initials: S
authors.lastname: Piva
authors.affiliation: School of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hile
authors.affiliation: School of Medicine, Biostatistics, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Dana
authors.initials: D
authors.lastname: Tudorascu
authors.affiliation: Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Sally C
authors.initials: SC
authors.lastname: Morton
keywords: Chiropractic; Lumbar spinal stenosis; Non-surgical treatment; Physical therapy; Rehabilitation; Spine