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Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-Blind, Randomised Controlled Trial
Indexado
WoS WOS:000908816000001
Scopus SCOPUS_ID:85145967210
DOI 10.3390/IJERPH20010311
Año 2023
Tipo artículo de investigación

Citas Totales

Autores Afiliación Chile

Instituciones Chile

% Participación
Internacional

Autores
Afiliación Extranjera

Instituciones
Extranjeras


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.

Métricas Externas



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Disciplinas de Investigación



WOS
Public, Environmental & Occupational Health
Environmental Sciences
Scopus
Sin Disciplinas
SciELO
Sin Disciplinas

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Publicaciones WoS (Ediciones: ISSHP, ISTP, AHCI, SSCI, SCI), Scopus, SciELO Chile.

Colaboración Institucional



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Autores - Afiliación



Ord. Autor Género Institución - País
1 Bascour-Sandoval, Claudio Hombre Universidad de La Frontera - Chile
2 Gajardo-Burgos, Ruben Hombre Universidad de La Frontera - Chile
Universidad Austral de Chile - Chile
3 Muñoz-Poblete, Claudio Hombre Universidad de La Frontera - Chile
4 Riedemann-González, Pablo Hombre Universidad de La Frontera - Chile
5 Erices-Salas, Stephanie Mujer Consultorio Miraflores - Chile
6 Martinez-Molina, Agustin Hombre Universidad Autónoma de Madrid - España
UNIV AUTONOMA MADRID - España
7 Galvez-Garcia, German Hombre Universidad de La Frontera - Chile
Universidad de Salamanca - España
Univ Salamanca - España

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Financiamiento



Fuente
Agencia Nacional de Investigación y Desarrollo
National Research and Development Agency

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Agradecimientos



Agradecimiento
This work is support by a FONIS project (SA191003) from National Research and Development Agency (ANID, Chile). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Muestra la fuente de financiamiento declarada en la publicación.