Blinding effect of sham Fu's subcutaneous needling in a healthy population
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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. 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. 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. 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 evaluate the specific effects of FSN.
Source: 世界针灸杂志：英文版
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4402955958