NCT07537426

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Intractable Facial Paralysis(IFP) is often accompanied by ocular surface diseases(OSDs). This is because severe facial nerve injury and a prolonged recovery cycle occur in patients. Among these, incomplete eyelid closure, epiphora, and ocular motility disorders are the three most common conditions. These ocular surface problems may lead to exposure keratitis, conjunctivitis, and in severe cases, decreased visual acuity, which greatly affects daily work. In modern life, electronic products have become a necessity for work, study, and social interaction. Complete avoidance of electronic products is impossible for patients, which further aggravates ocular damage. At the same time, frequent use of electronic products leaves no time for damaged corneal epithelium to repair. This cumulative effect turns intermittent ocular surface damage into persistent damage. Currently, there are no clearly recommended therapeutic drugs for the recovery period of peripheral facial palsy in clinical guidelines. For accompanying OSDs, symptomatic and supportive treatments are commonly used clinically, such as sodium hyaluronate eye drops. However, due to long-term corneal exposure in these patients and frequent use of electronic products, artificial tears often fail to achieve ideal clinical efficacy. Therefore, exploring an "effective, safe, convenient, and sustainable" treatment method has important clinical value, which can solve long-term ocular problems during facial palsy in such patients. Existing studies have shown that intradermal acupuncture is effective for major depressive disorder, acute mountain sickness, pain and so on. But relatively few studies exist on its application in OSDs after IFP. To further verify the efficacy and safety of intradermal acupuncture therapy, a single-center, randomized, single-blinded, placebo-controlled parallel trial will be conducted. Through this study, a convenient, safe, and easily promotable therapeutic approach will be provided for OSDs after IFP.

Conditions

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	Sham intradermal acupuncture	The SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2028-03-25
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China