Safety Assessment of the Auto Manipulation Device for Acupuncture in Sprague-Dawley Rats: Preclinical Evaluation of the Prototype

BACKGROUND: The Auto Manipulation Device for Acupuncture (AMDA) is designed for providing stable, quantified effects and higher frequency when doing lifting and thrusting manipulation. The purpose of this study is to investigate the safety of manipulation by AMDA in different frequency and duration in healthy rats. METHODS: The study was divided into two parts: single intervention and once a day for a week. 12 rats and 15 rats were randomly allocated to different groups: Control (needle insertion only), AMDA (2Hz/10Mins), AMDA (2Hz/20Mins), AMDA (20Hz/10Mins), and AMDA (20Hz/20Mins) for single and repeated interventions. Real-time physiological functions, laboratory data, and the bilateral muscle tissue of acupoint (ST 36) were obtained after the intervention. RESULTS: We found neither real-time physiological functions nor laboratory data differences between control group and AMDA groups in both parts. In the muscle tissue samples, the slight damage had been observed in the AMDA group with a frequency of 2 Hz for 20 minutes after once intervention, and the repeated session groups noted more obvious tissue damage with fibrotic change. Although the period was shorter, higher frequency manipulation caused more damage that fibroblast nuclei became more slender and obvious. However, no significant adverse effect was noted such as crippled and molting in the whole process. CONCLUSION: Our study suggested that the safety issue of AMDA operation in rats is feasible because there was no difference between control group and AMDA groups among real-time physiological functions and laboratory data. However, manipulation with higher frequency should be more preserved.