Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized control
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STUDY PROTOCOL
CHIROPRACTIC & MANUAL THERAPIES
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Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial Michael Schneider1*, Carlo Ammendolia2, Donald Murphy3,4, Ronald Glick5, Sara Piva1, Elizabeth Hile1, Dana Tudorascu6 and Sally C Morton7
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/design: 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. Discussion: 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. Trial registration: ClinicalTrials.gov identifier: NCT01943435 Keywords: Lumbar spinal stenosis, Spine, Rehabilitation, Physical therapy, Chiropractic, Non-surgical treatment
* Correspondence: [email protected] 1 School of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA Full list of author information is available at the end of the article © 2014 Schneider et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://cr
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