title: Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov ID: NCT02592642.
authors.affiliation: 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.
authors.forename: Carlo
authors.initials: C
authors.lastname: Ammendolia
authors.affiliation: Faculty of Health Sciences, University of Ontario Institute of Technology, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Côté
authors.affiliation: Department of Orthopedics, Toronto Western Hospital, University Health Network, Toronto, Canada.
authors.forename: Y Raja
authors.initials: YR
authors.lastname: Rampersaud
authors.affiliation: Division of Graduate Studies, Canadian Memorial Chiropractic College, Toronto, Canada.
authors.forename: Danielle
authors.initials: D
authors.lastname: Southerst
authors.affiliation: Division of Research, Canadian Memorial Chiropractic College, Toronto, Canada.
authors.forename: Brian
authors.initials: B
authors.lastname: Budgell
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Toronto, Toronto, Canada.
authors.forename: Claire
authors.initials: C
authors.lastname: Bombardier
authors.affiliation: Department of Medicine, Division of Rheumatology, University of Toronto, Toronto, Canada.
authors.forename: Gillian
authors.initials: G
authors.lastname: Hawker
keywords: Clinical protocol; Intermittent claudication; Randomized controlled trial; Spinal stenosis; Transcutaneous electrical nerve stimulation; Walking