Evaluating the Safety of Thread-Embedding Acupuncture: Protocol for a Multi-Center, Prospective, Observational Study...

Background/Objectives: Medical therapies that apply biodegradable materials, such as polydioxanone, are widely used to treat various disorders. Thread-embedding acupuncture (TEA) is a unique form of acupuncture that exerts long-lasting therapeutic effects by inserting absorbable threads at specific acupuncture points, and is widely used to treat various diseases. However, there is currently a lack of research regarding the safety of TEA. This prospective observational trial aims to evaluate the safety of TEA by collecting and analyzing data related to adverse events in patients receiving TEA in actual practice. Methods: A total of 350 eligible participants who undergo TEA at one of three university-affiliated hospitals and two traditional Korean medicine clinics will be systemically observed for post-treatment adverse reactions. The patients will be monitored at three time points: 1 week, 1 month, and 3 months post-treatment. Safety evaluations will assess the incidence of adverse events and treatment discontinuation rates during the 3-month post-treatment period. Conclusions: This study will evaluate the safety of TEA and provide information for decision-making in clinical practice as well as basic data for future large-scale research.