Efficacy of intradermal acupuncture for ocular surface diseases secondary to refractory peripheral facial palsy: a randomized controlled trial study protocol.
Jiayi Yao, Lusha Cen, Qiushuang Li...
https://pubmed.ncbi.nlm.nih.gov/42549110/Actively Recruiting
Led by The First Affiliated Hospital of Zhejiang Chinese Medical University · Updated on 2026-04-17
78
Participants Needed
1
Research Sites
51 weeks
Total Duration
Researchers are evaluating the clinical effects of intradermal acupuncture for treating ocular surface diseases that occur after intractable peripheral facial paralysis, a condition often accompanied by eye problems like incomplete eyelid closure and irritation. This study aims to determine whether intradermal acupuncture can effectively reduce symptoms measured by the Ocular Surface Disease Index OSDI compared to a placebo needle. The trial is a single-center, randomized, single-blinded, placebo-controlled parallel study aiming to find a convenient and safe treatment option for these eye conditions. Participants will receive basic background treatment and are randomly assigned to either an intradermal acupuncture group or a sham acupuncture group. The intradermal acupuncture involves inserting a small needle at specific points under sterile conditions, retaining it for 72 hours, and replacing it twice a week during a 4-week treatment period. Participants in the acupuncture group will also perform standardized self-administered pressing guided by a WeChat mini program three times daily. The sham group receives the basic treatment plus sham acupuncture without needle insertion. During the 4-week treatment and a 6-week follow-up, participants will have regular assessments every two weeks to measure outcomes including the OSDI score, tear meniscus height, tear film break-up time, meibomian gland imaging, eyelid closure width, and facial nerve function grading. These evaluations help researchers monitor symptom changes and safety. The total participation time covers treatment and follow-up to observe the effects over 10 weeks.
CONDITIONS
The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
B
Binyan Yu Binyan Yu
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The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive intradermal acupuncture or sham treatment along with basic background treatment for ocular surface diseases after facial paralysis.
Twice weekly visits for needle replacement and ongoing treatment
Duration - 6 weeks
Participants are monitored for 6 weeks after treatment to assess ocular surface disease and facial nerve function.
Assessments every 2 weeks during follow-up
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jiayi Yao, Lusha Cen, Qiushuang Li...
https://pubmed.ncbi.nlm.nih.gov/42549110/The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor