经皮电刺激神经疗法（TENS）与安慰剂对腰椎管狭窄症患者步行能力的影响：一项随机对照试验方案
Effect of TENS Versus Placebo on Walking Capacity in Patients With 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; Graduate Studies, Canadian Memorial Chiropractic College, Toronto, Canada.
Faculty of Health Sciences, University of Ontario Institute of Technology, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
出版信息
J Chiropr Med. 2016 Sep;15(3):197-203. doi: 10.1016/j.jcm.2016.04.001. Epub 2016 Jun 20.
BACKGROUND
Lumbar spinal stenosis (LSS) is a growing health problem and a leading cause of disability and loss of independence in older adults. It is usually caused by age-related degenerative narrowing of the spinal canals leading to compression and ischemia of the spinal nerves and symptoms of neurogenic claudication. Limited walking ability is the dominant functional impairment caused by LSS. Animal studies suggest increased blood flow to the spinal nerves and spinal cord with superficial paraspinal electrical stimulation. The purpose of this study is to assess the effectiveness of paraspinal transcutaneous electrical nerve stimulation (TENS) applied while walking on walking ability in patients with LSS.
METHODS/DESIGN: We propose to conduct a 2-arm double-blinded (participant and assessor) randomized controlled trial. We will recruit individuals who have limited walking ability due to degenerative LSS from hospital specialists, community physicians, and chiropractors located in the city of Toronto, Canada. Eligible consenting participants will be randomly assigned to either paraspinal TENS or placebo paraspinal TENS applied while walking. The primary outcome will be walking distance measured during a single self-paced walking test. We will calculate the differences in proportions among participants in both groups who achieve at least a 30% improvement in walking distance from baseline using Pearson χ (2) test with 95% confidence intervals.
DISCUSSION
Effective nonoperative interventions for LSS are unknown. Interventions that can improve blood flow to the spinal nerves while walking may increase walking ability in this population. Transcutaneous electrical nerve stimulation is a low-cost intervention that may have the potential to achieve this objective. To our knowledge, this study will be the first clinical trial to assess the effects of TENS on walking ability of patients with LSS.
TRIAL REGISTRATION
ClinicalTrials.gov ID: NCT02592642.
背景
腰椎管狭窄症（LSS）是一个日益严重的健康问题，是老年人残疾和失去独立生活能力的主要原因。它通常由与年龄相关的椎管退行性狭窄引起，导致脊神经受压和缺血以及神经源性间歇性跛行症状。行走能力受限是LSS导致的主要功能障碍。动物研究表明，浅层椎旁电刺激可增加脊神经和脊髓的血流量。本研究的目的是评估在行走时应用椎旁经皮电神经刺激（TENS）对LSS患者行走能力的有效性。
方法/设计：我们建议进行一项双臂双盲（参与者和评估者）随机对照试验。我们将从加拿大多伦多市的医院专科医生、社区医生和脊椎按摩师中招募因退行性LSS而行走能力受限的个体。符合条件并同意参与的参与者将被随机分配到行走时接受椎旁TENS或安慰剂椎旁TENS治疗。主要结局将是在单次自定步速行走测试中测量的行走距离。我们将使用Pearson χ（2）检验和95%置信区间计算两组中行走距离从基线至少提高30%的参与者比例的差异。
讨论
LSS有效的非手术干预措施尚不清楚。在行走时能改善脊神经血流量的干预措施可能会提高该人群的行走能力。经皮电神经刺激是一种低成本的干预措施，可能有潜力实现这一目标。据我们所知，本研究将是第一项评估TENS对LSS患者行走能力影响的临床试验。
试验注册
ClinicalTrials.gov标识符：NCT02592642。
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