Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial

doi:10.1016/j.jcm.2016.04.001

. 2016 Sep;15(3):197-203.

doi: 10.1016/j.jcm.2016.04.001. Epub 2016 Jun 20.

Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial

Carlo Ammendolia¹, Pierre Côté², Y Raja Rampersaud³, Danielle Southerst⁴, Brian Budgell⁵, Claire Bombardier⁶, Gillian Hawker⁶

Affiliations

¹ 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.
² Faculty of Health Sciences, University of Ontario Institute of Technology, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
³ Department of Orthopedics, Toronto Western Hospital, University Health Network, Toronto, Canada.
⁴ Division of Graduate Studies, Canadian Memorial Chiropractic College, Toronto, Canada.
⁵ Division of Research, Canadian Memorial Chiropractic College, Toronto, Canada.
⁶ Department of Medicine, Division of Rheumatology, University of Toronto, Toronto, Canada.

PMID: 27660596
PMCID: PMC5021899
DOI: 10.1016/j.jcm.2016.04.001

Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial

Carlo Ammendolia et al. J Chiropr Med. 2016 Sep.

. 2016 Sep;15(3):197-203.

doi: 10.1016/j.jcm.2016.04.001. Epub 2016 Jun 20.

Authors

Carlo Ammendolia¹, Pierre Côté², Y Raja Rampersaud³, Danielle Southerst⁴, Brian Budgell⁵, Claire Bombardier⁶, Gillian Hawker⁶

Affiliations

¹ 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.
² Faculty of Health Sciences, University of Ontario Institute of Technology, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
³ Department of Orthopedics, Toronto Western Hospital, University Health Network, Toronto, Canada.
⁴ Division of Graduate Studies, Canadian Memorial Chiropractic College, Toronto, Canada.
⁵ Division of Research, Canadian Memorial Chiropractic College, Toronto, Canada.
⁶ Department of Medicine, Division of Rheumatology, University of Toronto, Toronto, Canada.

PMID: 27660596
PMCID: PMC5021899
DOI: 10.1016/j.jcm.2016.04.001

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/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.

Keywords: Clinical protocol; Intermittent claudication; Randomized controlled trial; Spinal stenosis; Transcutaneous electrical nerve stimulation; Walking.

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Figures

**Fig 1**
Process of recruitment, randomization, and outcomes assessment. *TENS*, transcutaneous electrical nerve stimulation.

**Fig 2**
Inclusion and exclusion criteria. CT, computed tomography; *MRI*, magnetic resonance imaging.

**Fig 3**
Measures collected at baseline.

See this image and copyright information in PMC

Cited by

Effect of active TENS versus de-tuned TENS on walking capacity in patients with lumbar spinal stenosis: a randomized controlled trial.
Ammendolia C, Côté P, Rampersaud YR, Southerst D, Schneider M, Ahmed A, Bombardier C, Hawker G, Budgell B. Ammendolia C, et al. Chiropr Man Therap. 2019 Jun 19;27:24. doi: 10.1186/s12998-019-0245-z. eCollection 2019. Chiropr Man Therap. 2019. PMID: 31244992 Free PMC article. Clinical Trial.

References

1. Takahashi K, Kagechika K, Takino T, Matsui T, Miyazaki T, Shima I. Changes in epidural pressure during walking in patients with lumbar spinal stenosis. Spine. 1995;20(24):2746–2749. - PubMed
1. Fanuele JC, Birkmeyer NJ, Abdu WA, Tosteson TD, Weinstein JN. The impact of spinal problems on the health status of patients: have we underestimated the effect? Spine. 2000;25(12):1509–1514. - PubMed
1. Katz JN, Dalgas M, Stucki G, Katz NP, Bayley J, Fossel AH. Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination. Arthritis Rheum. 1995;38(9):1236–1241. - PubMed
1. Winter CC, Brandes M, Muller C, Schubert T, Ringling M, Hillmann A. Walking ability during daily life in patients with osteoarthritis of the knee or the hip and lumbar spinal stenosis: a cross sectional study. BMC Musculoskelet Disord. 2010;11:233. - PMC - PubMed
1. Suri P, Rainville J, Kalichman L, Katz JN. Does this older adult with lower extremity pain have the clinical syndrome of lumbar spinal stenosis? JAMA. 2010;304(23):2628–2636. - PMC - PubMed

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[1] Takahashi K, Kagechika K, Takino T, Matsui T, Miyazaki T, Shima I. Changes in epidural pressure during walking in patients with lumbar spinal stenosis. Spine. 1995;20(24):2746–2749. - PubMed

[2] Takahashi K, Kagechika K, Takino T, Matsui T, Miyazaki T, Shima I. Changes in epidural pressure during walking in patients with lumbar spinal stenosis. Spine. 1995;20(24):2746–2749. - PubMed

[3] Fanuele JC, Birkmeyer NJ, Abdu WA, Tosteson TD, Weinstein JN. The impact of spinal problems on the health status of patients: have we underestimated the effect? Spine. 2000;25(12):1509–1514. - PubMed

[4] Fanuele JC, Birkmeyer NJ, Abdu WA, Tosteson TD, Weinstein JN. The impact of spinal problems on the health status of patients: have we underestimated the effect? Spine. 2000;25(12):1509–1514. - PubMed

[5] Katz JN, Dalgas M, Stucki G, Katz NP, Bayley J, Fossel AH. Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination. Arthritis Rheum. 1995;38(9):1236–1241. - PubMed

[6] Katz JN, Dalgas M, Stucki G, Katz NP, Bayley J, Fossel AH. Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination. Arthritis Rheum. 1995;38(9):1236–1241. - PubMed

[7] Winter CC, Brandes M, Muller C, Schubert T, Ringling M, Hillmann A. Walking ability during daily life in patients with osteoarthritis of the knee or the hip and lumbar spinal stenosis: a cross sectional study. BMC Musculoskelet Disord. 2010;11:233. - PMC - PubMed

[8] Winter CC, Brandes M, Muller C, Schubert T, Ringling M, Hillmann A. Walking ability during daily life in patients with osteoarthritis of the knee or the hip and lumbar spinal stenosis: a cross sectional study. BMC Musculoskelet Disord. 2010;11:233. - PMC - PubMed

[9] Suri P, Rainville J, Kalichman L, Katz JN. Does this older adult with lower extremity pain have the clinical syndrome of lumbar spinal stenosis? JAMA. 2010;304(23):2628–2636. - PMC - PubMed

[10] Suri P, Rainville J, Kalichman L, Katz JN. Does this older adult with lower extremity pain have the clinical syndrome of lumbar spinal stenosis? JAMA. 2010;304(23):2628–2636. - PMC - PubMed

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Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial

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Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial

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