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Recruiting NCT07537426

NCT07537426 The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis

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Clinical Trial Summary
NCT ID NCT07537426
Status Recruiting
Phase
Sponsor The First Affiliated Hospital of Zhejiang Chinese Medical University
Condition Facial Paralysis, Peripheral
Study Type INTERVENTIONAL
Enrollment 78 participants
Start Date 2026-04-01
Primary Completion 2027-04-01

Trial Parameters

Condition Facial Paralysis, Peripheral
Sponsor The First Affiliated Hospital of Zhejiang Chinese Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 78
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2026-04-01
Completion 2027-04-01
Interventions
Intradermal acupuncture treatmentSham intradermal acupuncture

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Brief 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 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 lo

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