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 the National Natural Science Foundation of China(Nos.51374112 and 51474134)the Fujian Provincial Natural Science Foundation of China(No.2014J01160)+1 种基金the Open Research Fund of State Key Laboratory for Geomechanics and Deep Underground Engineering,China University of Mining and Technology(No.SKLGDUEK1304)the Promotion Program for Young and Middle-aged Teacher in Science and Technology Research of Huaqiao University(No.ZQN-PY112),China
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.
