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.

Abstract

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