Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy

Официальное название

Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2×2 Factorial Trial

Обзор

This study aims to assess the effect of intradermal acupuncture(IA) and guided self-rehabilitation management program(GRMP) (either single or combined) for patients with severe Bell's Palsy.

Подробное описание

After confirming the details of the trial process and signing an informed consent, all participants will be randomly divided into the following four groups: Active IA+GRMP, Active IA+ HE, sham IA+ GRMP, sham IA + HE. They will receive active or sham IA and GRMP or HE until complete recovery or completion of follow up (a duration of 24 weeks).Follow-ups will be done in 4-week, 8-week, 12-week,16-week, 20-week, and 24-week.

Вмешательства

• Устройство Active Intradermal Acupuncture
  Depending on acupoints' location, φ0.20\*1.5mm or φ0.20\*1.2mm AIA will be selected. Insert the Active IA vertically into the acupoint and retain it in the skin. Active IA will be retained for 72 hours with a day's rest after removal. During the period of needle retention, participants will be required to press the Active IA 4 times a day for approximately 1 minute each time, with as much stimulation as the patient can tolerate, at intervals of approximately 4 hours.
• Устройство Sham Intradermal Acupuncture
  Sham intradermal acupuncture will be attached to the acupoints and retained for 72 hours with a day's rest after removal. During the period of sham needle retention,pressing times and frequencies are identical to those in the active intradermal acupuncture group.
• Другое Guided self-rehabilitation management program
  Self-rehabilitation techniques are taught in individual sessions of about 40 minutes at each outpatient clinic visit, as detailed below: Analysis of the problem, Education, Massage, Facial muscles exercise,Synkinesis or spasticity management, Homework. Participants are requested to perform daily facial muscle exercises as prescribed by the therapist and keep the written diary on a daily basis. The therapists retrieve and evaluate the diaries at each visit.
• Другое Health Education
  Health education knowledge about the disease such as etiology, pathology,clinical symptoms of Bell's palsy, Bell's palsy diagnosis and role of medical tests;medication education;complications and sequelae,etc

Первичные конечные точки

• The proportion of participants with complete recovery of facial function at the 24-week. [Срок оценки: Week 24]

Вторичные конечные точки (12)

• The proportion of participants with complete recovery of facial function. [Срок оценки: Week4, Week8, Week12, Week16, Week20]
• The time to complete recovery of facial function. [Срок оценки: Within 24 weeks]
• The proportion of participants to reach a House-brackmann facial nerve grading system grade of I. [Срок оценки: Week4, Week8, Week12, Week16, Week20, Week24]
• The changes in Sunnybrook Facial Grading System score from baseline. [Срок оценки: Week4, Week8, Week12, Week16, Week20, Week24]
• The changes in Surface Electromyography from baseline. [Срок оценки: Week4, Week12, Week24]
• The changes in Facial Disability Index physical function subscale from baseline. [Срок оценки: Week4, Week12, Week24]
• The changes in Social Appearance Anxiety Scale from baseline. [Срок оценки: Week4, Week12, Week24]
• The changes in Facial Disability Index social/wellbeing function subscale from baseline [Срок оценки: Week4, Week12, Week24]
• The changes in Facial Clinimetric Evaluation Scale from baseline. [Срок оценки: Week4, Week12, Week24]
• The changes in visual analogue scale from baseline. [Срок оценки: Week4, Week8]
• The proportion of participants with synkinesis. [Срок оценки: Week 24]
• The proportion of participants with facial spasm or contracture [Срок оценки: Week 24]

Критерии участия

Критерии включения

• Patients diagnosed with Bell's palsy according to "Clinical Practice Guideline: Bell's Palsy" published by AAO-HNS in 2013;
• First onset of Bell's palsy with only one side affected;
• On the 10th day after the onset of palsy, HBGS score ranging from grade IV to VI;
• According to the latest Chinese Guidelines for Bell's Palsy, within 72 hours of symptom onset for Bell's Palsy, oraling prednisolone 30mg qd for 5 days, followed by tapering to zero in decrements of 5 mg per day;
• Adults aged 18 years of age or older (no limitation on gender).

Критерии исключения

• Facial paralysis caused by acoustic neuroma, otitis media, mastoiditis, mumps, Hunter's syndrome, cranial base meningitis, intracranial metastasis of cancer or multiple sclerosis;
• Fear of intradermal acupuncture;
• allergy to adhesive tape;
• Severe allergic diseases, significant skin lesions, tumors, and severe or unstable internal diseases involving the cardiovascular, respiratory, endocrine, digestive, or hematological system;
• Cognitive impairment, mental illness, contagious disease, pregnant and lactating;
• Previously treated withintradermal acupuncture or participating in other clinical trial within 3 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhangjiagang First People's Hospital — Сучжоу

Идентификаторы

NCT: NCT06778473 · ZJGYYLL202407030 · LSD2022020 · ZJGQNKJ202231

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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