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Идёт набор NCT06702046

The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

Без фазы С лечением Osteoarthritis (OA) of the Knee

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: transcutaneous pulsed radiofrequency acupuncture, Sham Comparison.
Кому может быть актуально
Состояния в реестре: Osteoarthritis (OA) of the Knee. Базовые параметры: 45 лет — 85 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
Тайвань
Следующий шаг
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Обзор

Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.

Подробное описание

With the aging population, knee osteoarthritis (KOA) has become a major issue affecting functional living and causing socioeconomic burdens. Its etiology includes biomechanical abnormalities, genetics, hormones, and environmental factors. KOA causes pain, stiffness, and muscle weakness, affecting daily activities and quality of life. Previous studies have shown that traditional acupuncture or electroacupuncture can improve pain and function in knee osteoarthritis. In recent years, pulsed radiofrequency therapy has gradually been applied for pain control in KOA. However, both treatments are invasive, and patients may fear and avoid needle insertion, which also has a higher risk of complications. This study aims to combine the strengths of both treatments by using transcutaneous pulsed radiofrequency(TCPRF) at acupuncture points. This non-invasive treatment approach aims to achieve effective pain control, allowing patients to participate more actively in rehabilitation therapy.

Вмешательства

  • Устройство transcutaneous pulsed radiofrequency acupuncture
    For the TCPRF acupuncture group, the investigators choose ST34 (Liangqiu), SP10 (Xuehai), GB34 (Yanglingquan), SP9 (Yinlingquan) around the affected knee. The TCPRF device is a wearable modality with innovative pulse radiofrequency technology aimed at alleviating symptomatic chronic pain, which revealed that UHF (500-kHz sine wave, 2-Hz frequency with a 25-ms pulse). It was attached to the electrode pad through magnetic attraction. A 500-KHz stimulus was delivered. The symmetric two-phase sine w
  • Устройство Sham Comparison
    same protocol will be done on the same acupoints, but the machine will be turn off interiorly. Therefore, although the machine still has lights and a vibrating sensation, it will not release PRF waves.

Первичные конечные точки

  • Western Ontario and McMaster Universities Osteoarthritis Index [Срок оценки: From enrollment to the end of treatment at 4 weeks]
Вторичные конечные точки (6)
  • Western Ontario and McMaster Universities Osteoarthritis Index [Срок оценки: 12 weeks after completing treatment]
  • visual analogue scale [Срок оценки: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • Tampa Scale for Kinesiophobia [Срок оценки: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • World Health Organization Quality of Life-Brief Version [Срок оценки: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • Biodex Stability System [Срок оценки: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]
  • Timed Up and Go [Срок оценки: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment]

Критерии участия

Критерии включения

  • Age from 45 to 85 year-old with knee pain for more than six months
  • Fulfill the combined clinical and radiographic criteria of knee OA established by the American College of Rheumatology with a Kellgren and Lawrence score of 2 or greater
  • Pain score above 3 (range 0-10 on the visual analog scale; higher scores indicate greater pain
  • Could participate in 4 weeks of treatment and 3 months of follow-up

Критерии исключения

  • Knee OA combined with any infection, inflammation, autoimmune disease, or fracture
  • History or underlying disease that would affect posture and balance, such as malignancy, dizziness, vertigo, or stroke
  • Ever underwent any type of knee operation or internal fixation
  • Pregnant or planning to become pregnant
  • Receiving other treatment for knee OA in previous 3 months
  • History of epilepsy, electronic devices implanted in the body
  • Active infection at the stimulator contact site
  • Lack of informed consent
  • Any other reason thought likely to result in inability to complete the trial

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

Тайвань · 1 центр
  • Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Идентификаторы

NCT: NCT06702046 · 20240723R

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗