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Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-Blind, Randomised Controlled Trial

Author

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  • Claudio Bascour-Sandoval

    (Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco 4780000, Chile
    Programa de Magister en Terapía Física Mención Musculoesquelética, Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco 4780000, Chile)

  • Rubén Gajardo-Burgos

    (Programa de Magister en Terapía Física Mención Musculoesquelética, Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco 4780000, Chile
    Instituto de Aparato Locomotor y Rehabilitación, Facultad de Medicina, Universidad Austral de Chile, Valdivia 5090000, Chile)

  • Claudio Muñoz-Poblete

    (Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco 4780000, Chile
    Programa de Magister en Terapía Física Mención Musculoesquelética, Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco 4780000, Chile)

  • Pablo Riedemann-González

    (Departamento de Medicina Interna, Universidad de La Frontera, Temuco 4780000, Chile)

  • Stephanie Erices-Salas

    (Consultorio Miraflores, Temuco 4790706, Chile)

  • Agustín Martínez-Molina

    (Departamento de Psicología Social y Metodología, Facultad de Psicología, Universidad Autónoma de Madrid, 28049 Madrid, Spain)

  • Germán Gálvez-García

    (Departamento de Psicología, Universidad de La Frontera, Temuco 4780000, Chile
    Departamento de Psicología Básica, Psicobiología y Metodología de las Ciencias del Comportamiento, Universidad de Salamanca, 37008 Salamanca, Spain)

Abstract

Current treatments for knee osteoarthritis (KOA) are partially effective. It is, therefore, necessary to find new strategies that can complement the existing ones. In this scenario, transcutaneous vagal stimulation (TVS) neurophysiological effects could be a helpful solution. However, there is no evidence of the efficacy of TVS in KOA. This trial aims to assess the efficacy of TVS in decreasing pain in participants aged 55 years or older with KOA. A randomised controlled, two-arm, double-blind (participants and outcome assessors) and clinical superiority trial will be conducted for 70 patients with KOA. All the participants will carry out an exercise program. It consists of 12 sessions over four weeks. In addition, they will be randomly assigned to (1) active TVS plus physical exercise or (2) sham TVS plus physical exercise. The application of active TVS consists of electronic stimulation of the auricular concha using a portable device. Sham TVS condition consists of the stimulation of the earlobe that does not cause neurophysiological effects. The primary outcome is the reduction in pain intensity. Additionally, functional capacity, physical performance, pain-related interference, pain-related distress, quality of life in older adults and global change will be measured. Assessments will be conducted at the beginning of the study (baseline), at the end of the intervention and after 1 and 3 months of follow-up. This trial will generate evidence regarding the efficacy of TVS in pain perception in individuals with KOA. This information will serve as an input in the clinical decision-making on the use or non-use of TVS in individuals with KOA. Thus, if the efficacy of TVS is confirmed, a new therapeutic tool may be included in the rehabilitation of individuals with KOA.

Suggested Citation

  • Claudio Bascour-Sandoval & Rubén Gajardo-Burgos & Claudio Muñoz-Poblete & Pablo Riedemann-González & Stephanie Erices-Salas & Agustín Martínez-Molina & Germán Gálvez-García, 2022. "Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-Blind, Randomised Controlled Trial," IJERPH, MDPI, vol. 20(1), pages 1-13, December.
    • Handle: RePEc:gam:jijerp:v:20:y:2022:i:1:p:311-:d:1014358
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    References listed on IDEAS

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    1. Kenneth F Schulz & Douglas G Altman & David Moher & for the CONSORT Group, 2010. "CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials," PLOS Medicine, Public Library of Science, vol. 7(3), pages 1-7, March.
    2. Lyudmila V. Borovikova & Svetlana Ivanova & Minghuang Zhang & Huan Yang & Galina I. Botchkina & Linda R. Watkins & Haichao Wang & Naji Abumrad & John W. Eaton & Kevin J. Tracey, 2000. "Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin," Nature, Nature, vol. 405(6785), pages 458-462, May.
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