Efficacy of intradermal acupuncture for ocular surface diseases secondary to refractory peripheral facial palsy: a randomized controlled trial study protocol.

INTRODUCTION

Refractory Peripheral Facial Palsy (RPFP) is defined as peripheral facial paralysis (PFP) that fails to achieve significant clinical recovery despite conventional therapeutic interventions. Due to severe facial nerve injury and a prolonged recovery course, RPFP often results in lagophthalmos, which in turn predisposes to ocular surface diseases (OSDs), most commonly exposure keratitis and dry eye disease. Currently, symptomatic and supportive therapies such as sodium hyaluronate eye drops are standard for managing OSDs secondary to RPFP, yet no other effective treatments have been established. This study aims to systematically evaluate the efficacy and safety of intradermal acupuncture (IA) as a potential therapeutic intervention for OSDs secondary to RPFP.

METHODS AND ANALYSIS: This is a pilot, single-center, two-arm randomized controlled trial protocol to be conducted at The First Affiliated Hospital of Zhejiang Chinese Medical University. A total of 78 eligible participants will be randomly allocated to the intradermal acupuncture group (IA group, n = 39) or the sham acupuncture group (SIA group, n = 39) at a 1:1 ratio. Both groups will receive a 4-week intervention period followed by a 6-week follow-up phase. Participants in the IA group will receive IA treatment, while those in the SIA group will receive SIA treatment with placebo needles. During the treatment period, the WeChat mini-program "Facial Palsy Ocular Comfort Smart Assistant" will be employed to intelligently assist patients in performing self-administered IA pressing. The primary outcome measure is the proportion of participants with a ≥ 12-point reduction in Ocular Surface Disease Index (OSDI) score from baseline to 4-week intervention. Secondary outcome measures include ocular surface function assessments [Tear Meniscus Height (TMH), Non-invasive Tear Film Break-Up Time (NIBUT), Meibography], Paralytic Lagophthalmos Measurement (PLM), and Facial Nerve Grading Scale 2.0 (FNGS 2.0) score. This study aims to investigate the clinical efficacy of IA intervention for OSDs secondary to RPFP and explore an effective, convenient therapeutic strategy for OSDs secondary to RPFP.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT07537426.