Intradermal acupuncture for ocular surface problems after intractable facial paralysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares intradermal acupuncture to a sham intradermal needle in adults with intractable peripheral facial paralysis who have symptomatic ocular surface disease. The primary outcome is change in Ocular Surface Disease Index (OSDI) score, with participants receiving regular treatment sessions and follow-up assessments. Eligible participants are 18–65 years old, have facial paralysis lasting 1 month to 1 year, and present moderate-to-severe OSDI scores, while key exclusions include other active ocular disease or recent eye surgery. The protocol aims to determine whether a safe, convenient acupuncture approach can reduce symptoms and improve ocular surface health.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Binyan Yu Binyan Yu
• Email: 20103034@zcmu.edu.cn
• Phone: 13758271294

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.