Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: PEMF, Alfredson eccentric training program.
- Кому может быть актуально
- Состояния в реестре: Mid-portion Achilles Tendinopathy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Гонконг
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Multicentre Randomised Controlled Trial of Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy（EM-MAT Trial)
Обзор
This is a multi-centre, randomised, double-blind, placebo-controlled trial with two parallel groups in a 1:1 allocation to study the efficacy of Pulsed Electromagnetic Field Therapy (PEMF) in patients with mid-portion Achilles tendinopathy. All participants will be randomly divided into two groups: an intervention group (active PEMF and standard rehabilitation exercise) and a control group (sham PEMF and standard rehabilitation exercise). All self-reported, functional, and ultrasound findings will be evaluated by the investigator at baseline assessment, 1-month, 2-month, 3-month, 6-month and 12-month follow-up after initiating the intervention. The researcher will obtain written consent from all participants before the start of this study. All eligible participants will be informed about this study and given enough time to consider whether or not to participate; the clinician/research staff will answer all questions asked by the participants. The trial will be conducted in accordance with the Declaration of Helsinki and the ICH-GCP. Clinical research ethics approval for the trial will be obtained from the Joint Clinical Research Ethics Committee of The Chinese University of Hong Kong. All participants will be recruited from the clinics and centres of the participating institutions.
Вмешательства
- Устройство PEMF
The PEMF will be delivered using a BIXEPS device (Quantum Tx, Singapore) ; It is utilised by the patient placing the leg into the machine. This device is operated by participant individualized NFC cards, which will be centrally programmed to deliver either active PEMF (uniform 1mT, 50Hz) or sham PEMF (0mT, 0Hz) for 30 minutes. Because this biophysical intervention is non-invasive, and the electromagnetic fields emitted into the legs do not generate any sensation (e.g. heat, sound), participants - Поведенческое Alfredson eccentric training program
All participants will be subject to a standardised rehabilitation exercise region consisting of stretching and eccentric exercises following the Alfredson protocol. The 12-week program will be taught by a physiotherapist or athletic trainer and supplemented by video tutorials. The regime begins with three 30-second static stretches for the gastrocnemius (knee extension) and soleus (knee flexion) muscles with 1-minute rest between each stretch. The 2nd part is eccentric exercises to the calves fo
Первичные конечные точки
- Victorian Institute of Sports Assessment (VISA-A) [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
Вторичные конечные точки (8)
- Numeric Pain Rating Scale (NPRS) [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Foot and Ankle Outcome Scores (FAOS) [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Achilles tendon resting angle (ATRA) [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon thickness [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon cross sectional area [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon vascularity [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Tendon elasticity [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
- Calf muscle strength [Срок оценки: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention]
Критерии участия
Критерии включения
- Adults (>18 years of age)
- Clinical diagnosis of mid-Achilles tendinopathy
- VISA-A score of <60
- Ultrasound evidence of Achilles tendinopathy (thickening >7mm)
Критерии исключения
- Previous invasive treatment to the Achilles tendon (e.g. rupture repair, PRP injection etc)
- Contraindication to PEMF (e.g. pregnancy, pacemakers)
- Physical or psychological comorbidities impairing the ability to complete assessments (eg neurological deficits etc.)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Гонконг · 1 центр
- Prince of Wales Hospital — Shatin
Идентификаторы
NCT: NCT06969859 · 2025.193