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

NCT07537426 | Recruiting

• 1 other identifier: 2026-KLS-167-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Paralysis, Peripheral; Bell's Palsy; Ocular Surface Disease

Keywords

sequelae of facial paralysis; ocular surface disease; intradermal acupuncture

Outcome Measures

Primary Outcomes (1)

• ocular surface disease index

  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".

  The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Intradermal Acupuncture group(IA group)

EXPERIMENTAL

basic background treatment + IA treatment

Other: Intradermal acupuncture treatment

Sham Intradermal Acupuncture group(SIA group)

PLACEBO COMPARATOR

basic background treatment + SIA treatment

Other: Sham intradermal acupuncture

Interventions

Intradermal acupuncture treatment OTHER

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.

Intradermal Acupuncture group(IA group)

Sham intradermal acupuncture OTHER

The SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment.

Sham Intradermal Acupuncture group(SIA group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18-65 years.
• 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%.
• At least one subjective ocular symptom (dryness, foreign body sensation, burning, fatigue, redness, fluctuating vision) and OSDI scores between 30 and 80.
• Voluntarily provides written informed consent and can comply with treatment and follow-up.

You may not qualify if:

• Other ocular diseases (glaucoma, keratitis, retinopathy, acute inflammation of conjunctiva, sclera, cornea).
• \. Intraocular surgery or laser therapy within the past 90 days.
• Use of systemic or topical antibiotics or tear-affecting drugs within 3 weeks; dry eye medications within 2 weeks.
• Lacrimal passage obstruction, dacryocystitis, punctal occlusion, or neurological impairment preventing full eyelid closure.
• Coagulation disorders, open wounds, or local infection at intervention sites.
• Allergy to press-needle materials (stainless steel, adhesive tape).
• Pregnancy or lactation.
• Severe cardiac, hepatic, renal, psychiatric disorders, or malignant tumors.
• Participation in another clinical trial within the past month.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Facial Paralysis; Bell Palsy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Facial Nerve Diseases; Cranial Nerve Diseases

Central Study Contacts

Binyan Yu Binyan Yu

CONTACT

13758271294; 20103034@zcmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): March 25, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)