Dataset Information

The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial.

ABSTRACT:

Background

Lumbar spinal stenosis (LSS) causing neurogenic claudication is a leading cause of pain, disability and loss of independence in older adults. The prevalence of lumbar spinal stenosis is growing rapidly due to an aging population. The dominant limitation in LSS is walking ability. Postural, physical and psychosocial factors can impact symptoms and functional ability. LSS is the most common reason for spine surgery in older adults yet the vast majority of people with LSS receive non-surgical treatment. What constitutes effective non-surgical treatment is unknown. The purpose of this study is to evaluate the effectiveness of a multi-modal and self-management training program, known as the Boot Camp Program for LSS aimed at improving walking ability and other relevant patient-centred outcomes.

Methods

We will use a pragmatic two-arm randomized controlled single blinded (assessor) study design. Eligible and consenting participants will be randomized to receive from licensed chiropractors either a 6-week (twice weekly) self-management training program (manual therapy, education, home exercises) with an instructional workbook and video and a pedometer or a single instructional session with an instructional workbook and video and pedometer. The main outcome measure will be the self-paced walking test measured at 6 months. We will also assess outcomes at 8 weeks and 3 and 12 months.

Discussion

Symptoms and functional limitations in LSS are variable and influenced by changes in spinal alignment. Physical and psychological factors result in chronic disability for patients with LSS. The Boot Camp Program is a 6-week self-management training program aimed at the multi-faceted aspects of LSS and trains individuals to use self-management strategies. The goal is to provide life-long self-management strategies that maximize walking and overall functional abilities and quality of life.

Trial registration

ClinicalTrials.gov ID: NCT02592642.

SUBMITTER: Ammendolia C

PROVIDER: S-EPMC4948101 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial.

Ammendolia Carlo C Côté Pierre P Rampersaud Y Raja YR Southerst Danielle D Budgell Brian B Bombardier Claire C Hawker Gillian G

Chiropractic & manual therapies 20160718

<h4>Background</h4>Lumbar spinal stenosis (LSS) causing neurogenic claudication is a leading cause of pain, disability and loss of independence in older adults. The prevalence of lumbar spinal stenosis is growing rapidly due to an aging population. The dominant limitation in LSS is walking ability. Postural, physical and psychosocial factors can impact symptoms and functional ability. LSS is the most common reason for spine surgery in older adults yet the vast majority of people with LSS receive ...[more]

PMID: 27433335

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Project description: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.

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Dataset Information

The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial.

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