Objective:Fu's subcutaneous needling(FSN)has been shown potential positive effectiveness in clinical practice.However,its specific effects are still not clear.This study aims to evaluate the blinding effect of a n...Objective:Fu's subcutaneous needling(FSN)has been shown potential positive effectiveness in clinical practice.However,its specific effects are still not clear.This study aims to evaluate the blinding effect of a non-penetrating sham FSN needle,developed for the first time by the authors'research team in healthy participants.Furthermore,to provide a reliable control tool to assess the specific effects of FSN.Methods:We conducted a randomized,sham-controlled trial in 60 healthy participants divided into FSN group and sham FSN group in a 1:1 ratio.The participants were assessed according to blinding index(BI),pain intensity,sensation type and acceptability of needling.Results:The James'BI was(0.56,95%CI[0.45,0.67])for two groups.The Bang's BI was(0.50,95%CI[0.24,0.76])in the FSN group and(-0.36,95%CI[-0.67,-0.07])in the sham FSN group.There was no significant difference between needling pain intensity(P>0.05)and type of needling sensation.A total of 96.6%participants who received sham FSN and 86.6%participants who received FSN considered the needling acceptable or better.Conclusion:This study confirmed the effective blinding capability of the sham FSN needles in healthy participants,indicating that the novel non-penetrating sham FSN needle can be served as eligible control to evaluatethe specific effects of FSN.展开更多
基金Supported by Guangdong Key Laboratory of Acupuncture and Moxibustion:202,101.
文摘Objective:Fu's subcutaneous needling(FSN)has been shown potential positive effectiveness in clinical practice.However,its specific effects are still not clear.This study aims to evaluate the blinding effect of a non-penetrating sham FSN needle,developed for the first time by the authors'research team in healthy participants.Furthermore,to provide a reliable control tool to assess the specific effects of FSN.Methods:We conducted a randomized,sham-controlled trial in 60 healthy participants divided into FSN group and sham FSN group in a 1:1 ratio.The participants were assessed according to blinding index(BI),pain intensity,sensation type and acceptability of needling.Results:The James'BI was(0.56,95%CI[0.45,0.67])for two groups.The Bang's BI was(0.50,95%CI[0.24,0.76])in the FSN group and(-0.36,95%CI[-0.67,-0.07])in the sham FSN group.There was no significant difference between needling pain intensity(P>0.05)and type of needling sensation.A total of 96.6%participants who received sham FSN and 86.6%participants who received FSN considered the needling acceptable or better.Conclusion:This study confirmed the effective blinding capability of the sham FSN needles in healthy participants,indicating that the novel non-penetrating sham FSN needle can be served as eligible control to evaluatethe specific effects of FSN.
