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Идёт набор NCT04905745

The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy

— Наблюдательное Facial Paralysis, Peripheral

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: Korean integrative medicine.
Кому может быть актуально
Состояния в реестре: Facial Paralysis, Peripheral. Базовые параметры: 19 лет — 69 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
South Korea
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

The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study

Обзор

This is an observational study that evaluate the effectiveness and safety of Korean integrative treatments in patients with peripheral facial nerve palsy. Adulthood patients aged between 19 to 69 who were diagnosed with peripheral facial nerve palsy and receive Korean integrative treatments for facial palsy will be enrolled in the study and the change will be followed according to the Facial disability index (FDI) at the 3 month moment after baseline.

Подробное описание

This is an observational study that evaluate the effectiveness and safety of Korean integrative treatments in patients with peripheral facial nerve palsy. A total of 100 patients who are in age of from 19 to 69, diagnosed with peripheral facial nerve palsy, in acute to subacute stage, and who receive Korean integrative treatments for facial palsy will be enrolled in this study. This study is an observational study and the intervention will be decided not by researchers, but by physicians in the real clinical practice. The treatment will be entirely determined according to each subject's medical conditions by an experienced clinician who has received more than 6 years of education and more than 3 years of training. This study will only record the contents of the intervention. Among all the data generated during the study period, data deemed necessary can be collected in the case record forms. The intervention will also be determined by the clinician, and the researcher presented assessment and data collection timepoints, which is independent of the treatment schedule. The on-treatment visit schedule will be once a week during the treatment is ongoing, and follow-up visit schedule will be on the 5th, 14th, and 53rd weeks after the baseline.

Вмешательства

  • Процедура Korean integrative medicine
    Any kind of Korean integrative medicine will be applicable and the treatment will be entirely determined by experienced clinicians. On the premise of the above, the following examples are the treatments applicable to the subject of this observational study. * Chuna: Chuna therapy is performed on the face and cervical spine to induce decompression of the captured facial nerve. In addition, SJS Non-Resistance Technique-Facial palsy (SJS NRT-F), a technique of Chuna, can be performed to stimulate

Первичные конечные точки

  • Facial disability index [Срок оценки: week 14]
Вторичные конечные точки (7)
  • Facial disability index (FDI) [Срок оценки: week 1, 5, 14, 53]
  • House-Brackmann facial palsy grade system (HB grade) [Срок оценки: week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)]
  • Numeric rating scale (NRS) [Срок оценки: week 1, 5, 14, 53 and every week during treatment]
  • Facial nerve grading system (FNGS 2.0) [Срок оценки: week 1, 5, 14, 53]
  • Synkinesis Assessment Questionnaire (SAQ) [Срок оценки: week 1, 5, 14, 53]
  • Patient Global Impression of Change (PGIC) [Срок оценки: week 5, 14, 53]
  • Short Form-12 Health Survey (SF-12) [Срок оценки: week 1, 5, 14, 53]

Критерии участия

Критерии включения

  • age of 19 to 69
  • diagnosed with unilateral peripheral facial nerve palsy
  • onset of facial palsy within 3 weeks or less.
  • an individual who can provide written consent form to participate in the study.

Критерии исключения

  • diagnosed with central nervous system disease causing facial palsy
  • secondary facial palsy after multiple sclerosis, tumor, cerebrovascular disease and temporal bone fracture.
  • Ramsay-Hunt syndrome
  • bilateral or recurrent facial nerve palsy.
  • an individual who received any treatment that can have a significant effect on changes in facial paralysis within recent 2 month. (ie. facial nerve decompression surgery)
  • already or planned to be pregnant or breast-feeding within the study period.
  • uncontrolled diabetes mellitus within the last 3 months.
  • within a month after participating any other facial palsy-related clinical trials, or planning to participate other clinical trials within 6 month.
  • impossible to read and understand the documents, regarding informed consent form and the questionnaires.
  • difficult to participate according to the judgement of researchers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

South Korea · 1 центр
  • Jaseng Hospital of Korean Medicine — Seoul

Идентификаторы

NCT: NCT04905745 · JS-CT-2021-05

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗