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Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials

Transcutaneous tibial nerve stimulation (TTNS) is a promising treatment for neurogenic lower urinary tract symptoms. However, the evidence is limited due to a general lack of randomised controlled trials (RCTs) and, also, inconsistency in the sham and blinding conditions. In the context of much-need...

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Autores principales: Stalder, Stephanie A., van der Lely, Stéphanie, Anderson, Collene E., Birkhäuser, Veronika, Curt, Armin, Gross, Oliver, Leitner, Lorenz, Mehnert, Ulrich, Schubert, Martin, Tornic, Jure, Kessler, Thomas M., Liechti, Martina D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10377596/
https://www.ncbi.nlm.nih.gov/pubmed/37509569
http://dx.doi.org/10.3390/biomedicines11071931
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author Stalder, Stephanie A.
van der Lely, Stéphanie
Anderson, Collene E.
Birkhäuser, Veronika
Curt, Armin
Gross, Oliver
Leitner, Lorenz
Mehnert, Ulrich
Schubert, Martin
Tornic, Jure
Kessler, Thomas M.
Liechti, Martina D.
author_facet Stalder, Stephanie A.
van der Lely, Stéphanie
Anderson, Collene E.
Birkhäuser, Veronika
Curt, Armin
Gross, Oliver
Leitner, Lorenz
Mehnert, Ulrich
Schubert, Martin
Tornic, Jure
Kessler, Thomas M.
Liechti, Martina D.
author_sort Stalder, Stephanie A.
collection PubMed
description Transcutaneous tibial nerve stimulation (TTNS) is a promising treatment for neurogenic lower urinary tract symptoms. However, the evidence is limited due to a general lack of randomised controlled trials (RCTs) and, also, inconsistency in the sham and blinding conditions. In the context of much-needed RCTs, we aimed to develop a suitable sham-control protocol for a clinical setting to maintain blinding but avoid meaningful stimulation of the tibial nerve. Three potential electrode positions (lateral malleolus/5th metatarsal/plantar calcaneus) and two electrode sizes (diameter: 2.5 cm/3.2 cm) were tested to determine which combination provided the optimal sham configuration for a TTNS approach, based on a visible motor response. Sixteen healthy volunteers underwent sensory and motor assessments for each sham configuration. Eight out of them came back for an extra TTNS visit. Sensory thresholds were present for all sham configurations, with linear regression models revealing a significant effect regarding electrode position (highest at plantar calcaneus) but not size. In addition, motor thresholds varied with the position—lowest for the 5th metatarsal. Only using this position and 3.2 cm electrodes attained a 100% response rate. Compared to TTNS, sensory and motor thresholds were generally higher for the sham configurations; meanwhile, perceived pain was only higher at the lateral malleolus. In conclusion, using the 5th metatarsal position and 3.2 cm electrodes proved to be the most suitable sham configuration. Implemented as a four-electrode setup with standardized procedures, this appears to be a suitable RCT protocol for maintaining blinding and controlling for nonspecific TTNS effects in a clinical setting.
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spelling pubmed-103775962023-07-29 Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials Stalder, Stephanie A. van der Lely, Stéphanie Anderson, Collene E. Birkhäuser, Veronika Curt, Armin Gross, Oliver Leitner, Lorenz Mehnert, Ulrich Schubert, Martin Tornic, Jure Kessler, Thomas M. Liechti, Martina D. Biomedicines Article Transcutaneous tibial nerve stimulation (TTNS) is a promising treatment for neurogenic lower urinary tract symptoms. However, the evidence is limited due to a general lack of randomised controlled trials (RCTs) and, also, inconsistency in the sham and blinding conditions. In the context of much-needed RCTs, we aimed to develop a suitable sham-control protocol for a clinical setting to maintain blinding but avoid meaningful stimulation of the tibial nerve. Three potential electrode positions (lateral malleolus/5th metatarsal/plantar calcaneus) and two electrode sizes (diameter: 2.5 cm/3.2 cm) were tested to determine which combination provided the optimal sham configuration for a TTNS approach, based on a visible motor response. Sixteen healthy volunteers underwent sensory and motor assessments for each sham configuration. Eight out of them came back for an extra TTNS visit. Sensory thresholds were present for all sham configurations, with linear regression models revealing a significant effect regarding electrode position (highest at plantar calcaneus) but not size. In addition, motor thresholds varied with the position—lowest for the 5th metatarsal. Only using this position and 3.2 cm electrodes attained a 100% response rate. Compared to TTNS, sensory and motor thresholds were generally higher for the sham configurations; meanwhile, perceived pain was only higher at the lateral malleolus. In conclusion, using the 5th metatarsal position and 3.2 cm electrodes proved to be the most suitable sham configuration. Implemented as a four-electrode setup with standardized procedures, this appears to be a suitable RCT protocol for maintaining blinding and controlling for nonspecific TTNS effects in a clinical setting. MDPI 2023-07-07 /pmc/articles/PMC10377596/ /pubmed/37509569 http://dx.doi.org/10.3390/biomedicines11071931 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Stalder, Stephanie A.
van der Lely, Stéphanie
Anderson, Collene E.
Birkhäuser, Veronika
Curt, Armin
Gross, Oliver
Leitner, Lorenz
Mehnert, Ulrich
Schubert, Martin
Tornic, Jure
Kessler, Thomas M.
Liechti, Martina D.
Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials
title Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials
title_full Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials
title_fullStr Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials
title_full_unstemmed Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials
title_short Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials
title_sort development of a sham protocol to investigate transcutaneous tibial nerve stimulation in randomised, sham-controlled, double-blind clinical trials
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10377596/
https://www.ncbi.nlm.nih.gov/pubmed/37509569
http://dx.doi.org/10.3390/biomedicines11071931
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