腰椎管狭窄症新兵训练营计划：一项随机对照试验方案
The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial.
作者信息
Ammendolia Carlo, Côté Pierre, Rampersaud Y Raja, Southerst Danielle, Budgell Brian, Bombardier Claire, Hawker Gillian
机构信息
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada ; Rebecca MacDonald Centre for Arthritis & Autoimmune Disease, Mount Sinai Hospital, Toronto, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada ; Dalla Lana School of Public Health, University of Toronto, Toronto, Canada ; University of Ontario Institute of Technology, Ontario, Canada.
出版信息
Chiropr Man Therap. 2016 Jul 18;24:25. doi: 10.1186/s12998-016-0106-y. eCollection 2016.
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.
背景
导致神经源性间歇性跛行的腰椎管狭窄症（LSS）是老年人疼痛、残疾和失去独立生活能力的主要原因。由于人口老龄化，腰椎管狭窄症的患病率正在迅速上升。LSS的主要限制因素是行走能力。姿势、身体和心理社会因素会影响症状和功能能力。LSS是老年人脊柱手术最常见的原因，但绝大多数LSS患者接受的是非手术治疗。什么构成有效的非手术治疗尚不清楚。本研究的目的是评估一种多模式自我管理培训计划的有效性，该计划称为LSS训练营计划，旨在提高行走能力和其他以患者为中心的相关结果。
方法
我们将采用实用的双臂随机对照单盲（评估者）研究设计。符合条件并同意参与的参与者将被随机分配，由有执照的脊医提供为期6周（每周两次）的自我管理培训计划（手法治疗、教育、家庭锻炼），并配有指导手册、视频和计步器，或接受一次配有指导手册、视频和计步器的指导课程。主要结局指标将是在6个月时进行的自定步速行走测试。我们还将在8周、3个月和12个月时评估结局。
讨论
LSS的症状和功能限制各不相同，并受脊柱排列变化的影响。身体和心理因素导致LSS患者出现慢性残疾。训练营计划是一个为期6周的自我管理培训计划，针对LSS的多方面问题，训练个人使用自我管理策略。目标是提供终身自我管理策略，以最大限度地提高行走能力、整体功能能力和生活质量。
试验注册
ClinicalTrials.gov标识符：NCT02592642。
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