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The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
Condition(s) studied
Facial Paralysis, PeripheralBell's PalsyOcular Surface Disease
Investigational drug(s) / intervention(s)
Intradermal acupuncture treatmentSham intradermal acupuncture
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 self-administered pressing by a dedicated WeChat mini program: 3 times daily, 3 minutes per session, 60 presses per minute, stimulating as much as tolerated.
Sham intradermal acupuncture: The SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment.
Study summary
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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- ocular surface disease index — 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".
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine |
Hangzhou |
Zhejiang |
Recruiting |
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