Intradermal acupuncture for ocular surface problems after intractable facial paralysis

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

This study will test whether tiny needles placed just under the skin can improve dry eye and other ocular surface symptoms in adults with persistent peripheral facial paralysis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07537426 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–65 with persistent peripheral facial paralysis lasting 1 month to 1 year who report dry eye or related symptoms and have OSDI scores between 30 and 80 are the intended participants.

Not a fit: Patients with other active eye diseases (such as glaucoma or keratitis), recent intraocular surgery, lacrimal drainage obstruction, or inability to fully close the eyelid are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If effective, intradermal acupuncture could offer a low-risk, convenient option to reduce dry eye symptoms and help protect the cornea in people with long-standing facial paralysis.

How similar studies have performed: Small acupuncture studies for dry eye have reported mixed but sometimes positive results, while intradermal acupuncture specifically for post-facial-paralysis ocular surface disease is relatively novel and not yet well established.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Binyan Yu Binyan Yu

Conditions: Facial Paralysis, Peripheral, Bell's Palsy, Ocular Surface Disease, sequelae of facial paralysis, ocular surface disease, intradermal acupuncture