Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial.

OBJECTIVES: Acupuncture has been widely studied for its safety across multiple countries. Sterile acupuncture (SA), represented by the thumbtack needle, is commonly used due to its ease of application, minimal pain, and allowance of free movement. However, it is also associated with adverse events (AEs) such as foreign body sensation and allergic contact dermatitis. Biodegradable microneedle acupuncture (BMA) is a newly developed medical device that may overcome these limitations. This trial aims to confirm the superiority of BMA over SA (represented by the thumbtack needle) in terms of safety.

METHODS: A total of 224 participants diagnosed with dry eye disease, asthenopia, ocular pain, Bell's palsy and its sequelae, or ptosis will be recruited from two hospitals. Participants will be randomly assigned to receive either BMA or SA in a 11 ratio. Acupuncture will be performed at eight standardized points bilateral GB14, TE23, EX-HN5, and ST1. Treatments will be administered three times per week for four weeks by Korean medicine doctors or residents with at least three years of clinical experience. The needles will be removed by the participants after four hours. The primary outcome is the incidence of treatment-related AEs. Secondary outcomes include vital signs, blood test results, incidence of allergic reactions, visual analog scale (VAS) scores for symptoms, quality of life, Ocular Surface Disease Index (OSDI) scores, and treatment satisfaction.

CONCLUSION: This trial will provide evidence regarding the safety of BMA. The results may help clinicians select a safer alternative to conventional thumbtack needles, especially for patients with sensitive skin. In addition, findings may serve as reference data for regulatory evaluation of BMA safety and efficacy.