The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis

Обзор

The purpose of this study is to explore the clinical efficacy of intradermal acupuncture in the treatment of ocular surface diseases after Intractable Facial Paralysis, and to seek effective and convenient treatment for ocular surface diseases after intractable peripheral facial paralysis. The main question it aims to answer is ： Will the intradermal acupuncture intervention effectively reduce the OSDI score ? The researchers compared the intradermal acupuncture with the placebo-needle to observe whether the intradermal acupuncture could better improve the symptoms.

Подробное описание

Intractable Facial Paralysis(IFP) is often accompanied by ocular surface diseases(OSDs). This is because severe facial nerve injury and a prolonged recovery cycle occur in patients. Among these, incomplete eyelid closure, epiphora, and ocular motility disorders are the three most common conditions. These ocular surface problems may lead to exposure keratitis, conjunctivitis, and in severe cases, decreased visual acuity, which greatly affects daily work.

In modern life, electronic products have become a necessity for work, study, and social interaction. Complete avoidance of electronic products is impossible for patients, which further aggravates ocular damage. At the same time, frequent use of electronic products leaves no time for damaged corneal epithelium to repair. This cumulative effect turns intermittent ocular surface damage into persistent damage.

Currently, there are no clearly recommended therapeutic drugs for the recovery period of peripheral facial palsy in clinical guidelines. For accompanying OSDs, symptomatic and supportive treatments are commonly used clinically, such as sodium hyaluronate eye drops. However, due to long-term corneal exposure in these patients and frequent use of electronic products, artificial tears often fail to achieve ideal clinical efficacy. Therefore, exploring an "effective, safe, convenient, and sustainable" treatment method has important clinical value, which can solve long-term ocular problems during facial palsy in such patients.

Existing studies have shown that intradermal acupuncture is effective for major depressive disorder, acute mountain sickness, pain and so on. But relatively few studies exist on its application in OSDs after IFP. To further verify the efficacy and safety of intradermal acupuncture therapy, a single-center, randomized, single-blinded, placebo-controlled parallel trial will be conducted. Through this study, a convenient, safe, and easily promotable therapeutic approach will be provided for OSDs after IFP.

Вмешательства

• Другое Intradermal acupuncture treatment
  The IA group will receive basic background treatment. During the intervention phase, the group will receive IA treatment. After basic background treatment, IA treatment will adopt acupoints. Under strict aseptic conditions, a φ0.20\*1.2 mm IA(SEIRIN Co.,Japan) will puncture perpendicularly and retained in the skin.It will be retained for 72 hours and replaced twice weekly, with the entire intervention course lasting 4 weeks. During the IA treatment period, participants will perform standardized
• Другое Sham intradermal acupuncture
  The SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment.

Первичные конечные точки

• ocular surface disease index [Срок оценки: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.]

Вторичные конечные точки (5)

• tear meniscus height (TMH) [Срок оценки: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, the baseline, the 4th week, and the 10th week were evaluated.]
• Tear film break-up time (TBUT) [Срок оценки: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, the baseline, the 4th week, and the 10th week were evaluated]
• Meibomian Gland Imaging [Срок оценки: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, the baseline, the 4th week, and the 10th week were evaluated]
• The width of incomplete palpebral fissure closure [Срок оценки: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.]
• Facial Nerve Grading System 2.0(FNGS 2.0) [Срок оценки: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.]

Критерии участия

Критерии включения

• 1.Male or female patients aged 18-65 years.
• 2.Meets diagnostic criteria for intractable peripheral facial paralysis, with disease duration from 1 month to 1 year. FNGS 2.0 ≥15 points; ENoG shows the ratio of CMAP amplitude≤ 20%.
• 3.At least one subjective ocular symptom (dryness, foreign body sensation, burning, fatigue, redness, fluctuating vision) and OSDI scores between 30 and 80.
• 4.Voluntarily provides written informed consent and can comply with treatment and follow-up.

Критерии исключения

• 1.Other ocular diseases (glaucoma, keratitis, retinopathy, acute inflammation of conjunctiva, sclera, cornea).
• 2\. Intraocular surgery or laser therapy within the past 90 days.
• 3.Use of systemic or topical antibiotics or tear-affecting drugs within 3 weeks; dry eye medications within 2 weeks.
• 4.Lacrimal passage obstruction, dacryocystitis, punctal occlusion, or neurological impairment preventing full eyelid closure.
• 5.Coagulation disorders, open wounds, or local infection at intervention sites.
• 6.Allergy to press-needle materials (stainless steel, adhesive tape).
• 7.Pregnancy or lactation.
• 8.Severe cardiac, hepatic, renal, psychiatric disorders, or malignant tumors.
• 9.Participation in another clinical trial within the past month.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine — Ханчжоу

Публикации

• Yao J, Cen L, Li Q, Liu S, Zhu C, Xuan L, Yu B. Efficacy of intradermal acupuncture for ocular surface diseases secondary to refractory peripheral facial palsy: a randomized controlled trial study protocol. Front Med (Lausanne). 2026 Jul 20;13:1873689. doi: 10.3389/fmed.2026.1873689. eCollection 2026. PMID 42549110

Идентификаторы

NCT: NCT07537426 · 2026-KLS-167-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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