Objective:Acupotomy is a modern acupuncture method that includes modern surgical methods.Since acupotomy is relatively more invasive than filiform acupuncture treatment,it is important to establish the safety profile ...Objective:Acupotomy is a modern acupuncture method that includes modern surgical methods.Since acupotomy is relatively more invasive than filiform acupuncture treatment,it is important to establish the safety profile of this practice.To justify further large-scale prospective observational studies,this preliminary study was performed to assess the feasibility of the approach and investigate the safety profile and factors potentially associated with adverse events(AEs).Methods:This was a prospective pilot study that assessed the feasibility of a large-scale forthcoming safety study on acupotomy treatment in a real-world setting.The feasibility(call response rate,dropout rate,response rate for each variable and recruitment per month)and safety profile(incidence,type,severity and causality of AEs,and factors potentially associated with AEs)were measured.Results:A total of 28 participants joined the study from January to May 2018.A follow-up assessment was achieved in 258(1185 treatment points)out of 261 sessions(1214 treatment points).The response rate via telephone on the day after treatment was 87.3%.There were 8 systemic AEs in all the sessions(8/258;3.11%)and 27 local AEs on the total points treated(27/1185;2.28%).Severe AEs did not occur.Total AE and local AE occurrence were associated with blade width and the number of needle stimulations per treatment point.Conclusion:The findings suggest that it could be feasible to analyze the safety of acupotomy in a realworld setting.Moreover,the primary data on some relevant AEs could be determined.We are planning large-scale prospective studies based on these findings.Trial registration:Clinical Research Information Service(CRIS)KCT0002849(https://cris.nih.go.kr/cris/search/detailSearch.do/11487).展开更多
基金funded by the Korea Institute of Oriental Medicine(No.K18121)supported by the National Research Foundation of Korea grant funded by the Korea Government(Ministry of Science and ICT)(No.NRF-2022R1C1C2008738)。
文摘Objective:Acupotomy is a modern acupuncture method that includes modern surgical methods.Since acupotomy is relatively more invasive than filiform acupuncture treatment,it is important to establish the safety profile of this practice.To justify further large-scale prospective observational studies,this preliminary study was performed to assess the feasibility of the approach and investigate the safety profile and factors potentially associated with adverse events(AEs).Methods:This was a prospective pilot study that assessed the feasibility of a large-scale forthcoming safety study on acupotomy treatment in a real-world setting.The feasibility(call response rate,dropout rate,response rate for each variable and recruitment per month)and safety profile(incidence,type,severity and causality of AEs,and factors potentially associated with AEs)were measured.Results:A total of 28 participants joined the study from January to May 2018.A follow-up assessment was achieved in 258(1185 treatment points)out of 261 sessions(1214 treatment points).The response rate via telephone on the day after treatment was 87.3%.There were 8 systemic AEs in all the sessions(8/258;3.11%)and 27 local AEs on the total points treated(27/1185;2.28%).Severe AEs did not occur.Total AE and local AE occurrence were associated with blade width and the number of needle stimulations per treatment point.Conclusion:The findings suggest that it could be feasible to analyze the safety of acupotomy in a realworld setting.Moreover,the primary data on some relevant AEs could be determined.We are planning large-scale prospective studies based on these findings.Trial registration:Clinical Research Information Service(CRIS)KCT0002849(https://cris.nih.go.kr/cris/search/detailSearch.do/11487).
