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Effects of combining electrical stimulation of the calf and thigh muscles in patients with osteoarthritis of the knee: protocol for a double-blind, randomised, sham-controlled trial.
Briggs-Price, Samuel; Houchen-Wolloff, Linzy; Daynes, Enya; Gerlis, Charlotte; Latimer, Lorna; Mills, George Evan; Esler, Colin; Singh, Sally J.
Afiliación
  • Briggs-Price S; Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK samuel.briggs-price@uhl-tr.nhs.uk.
  • Houchen-Wolloff L; Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
  • Daynes E; Department of Respiratory Sciences, University of Leicester, Leicester, UK.
  • Gerlis C; Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
  • Latimer L; Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
  • Mills GE; Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
  • Esler C; Department of Respiratory Sciences, University of Leicester, Leicester, UK.
  • Singh SJ; Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
BMJ Open ; 12(8): e061113, 2022 08 25.
Article en En | MEDLINE | ID: mdl-36008074
INTRODUCTION: Knee osteoarthritis (KOA) is a leading cause of disability and is characterised by degenerative changes causing pain and loss of function. Neuromuscular electrical stimulation (NMES) has been shown to influence muscle size and strength in healthy subjects. A novel self-administered NMES device has been developed to help manage the symptoms of KOA. This study aims to investigate the effects of combining NMES of the calf and quadriceps on individuals with KOA. METHODS AND ANALYSIS: 193 individuals with KOA will be recruited to a single-centre, double-blind, randomised, sham-controlled trial at the Respiratory Biomedical Research Centre, Leicester, UK. Participants will be randomised (1:1) to follow an 8-week home-based intervention using a NMES device or sham device. The NMES device consists of footplate electrodes and two quadriceps electrodes. Footplate stimulation will be completed daily for 30 min and quadriceps stimulation for 20 min, five times a week (compliance is recorded in a self-reported participant diary). The primary outcome is the Western Ontario and McMaster Universities Arthritis Index pain domain, taken at 8 weeks follow-up. Secondary outcomes will explore quadriceps muscle strength, swelling, health-related quality of life, exercise capacity, anxiety and depression, sleep, physical activity and self-reported compliance. A powered subgroup analysis for compliance to the active device will be complete for the primary outcome. Participant focus groups will be completed following recruitment of half of the participants and after all participants have been recruited. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the North-West Preston ethics committee (17/NW/0081). Participants are required to provide informed consent following review of the participant information sheet and discussion regarding study procedures with a member of the research team. The study results will be disseminated to the appropriate stakeholders through presentations, conferences and peer-reviewed journals. Results will be presented to participants following study completion at the Biomedical Research Centre-Respiratory, Glenfield Hospital, Leicester. TRIAL REGISTRATION NUMBER: ISRCTN registry, ISRCTN12112819 (date registered 1 May 2019). IRAS registry 219 693. University Hospitals of Leicester registry 91 017. Protocol Version 8.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Osteoartritis de la Rodilla Tipo de estudio: Clinical_trials / Qualitative_research Aspecto: Ethics / Patient_preference Límite: Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Osteoartritis de la Rodilla Tipo de estudio: Clinical_trials / Qualitative_research Aspecto: Ethics / Patient_preference Límite: Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido