The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- ocular surface disease index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •4.Voluntarily provides written informed consent and can comply with treatment and follow-up.
排除标准
- •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.
研究组 & 干预措施
Intradermal Acupuncture group(IA group)
basic background treatment + IA treatment
干预措施: Intradermal acupuncture treatment (Other)
Sham Intradermal Acupuncture group(SIA group)
basic background treatment + SIA treatment
干预措施: Sham intradermal acupuncture (Other)
结局指标
主要结局
ocular surface disease index
时间窗: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.
After 4 weeks of treatment, the proportion of patients with OSDI index score decreased by more than 12 points from baseline. According to previous studies, the minimal clinically important difference (MCID) for the Ocular Surface Disease Index (OSDI) was 10 points, and the MCID of the severe dry eye population was 7.3\~13.4 points. At the same time, based on the pre-test results of this study, 12 points corresponded to "significant improvement in patient perception" in this study. Therefore, the OSDI score decreased by ≥12 points from the baseline after 4 weeks of treatment, which was considered as "effective treatment".
次要结局
- tear meniscus height (TMH)(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)(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(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(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)(The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.)