Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial.

Michael Schneider,Sara Piva,Elizabeth Hile,Ronald Glick,Dana Tudorascu,Donald Murphy,Sally C Morton,Carlo Ammendolia

doi:10.1186/2045-709x-22-19

Abstract

BackgroundLumbar 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/designThis 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.DiscussionOur 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 registrationClinicalTrials.gov identifier: NCT01943435

Highlights

Nearly 20% of the U.S population will be 65 years of age or older by the year 2030 and about 34% of them will suffer from some type of osteoarthritis [1]
Lumbar Spinal Stenosis (LSS) is a chronic condition that is caused by degenerative changes in the lumbar spine, which is highly prevalent in the older adult population
The severity of bony narrowing measured on MRI or CT does not correlate with the severity of patient symptoms [4,5], including the hallmark symptom of the clinical syndrome: significant leg pain that typically worsens with ambulation

Summary

Introduction

Background Nearly 20% of the U.S population will be 65 years of age or older by the year 2030 and about 34% of them will suffer from some type of osteoarthritis [1]. 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

Findings

Discussion

Conclusion