A single center, propensity-score stratified, assessor-blinded, prospective pragmatic controlled trial

Wei-Tao Chen, PhD Candidate,a,b,c Ce Sun, MM,d Ying-Bin Zhou, MM,c Dong-Hua Liu, MM,c Zhi-Long Peng, MM,cJing Chen, MM,a,b,c Nuo Xu, MS,f Yan-Yan Lei, MPH,a,j Jun He, PhD,e Chun-Zhi Tang, PhD, Xin-Feng Lin, BM,a,∗Neng-Gui Xu, PhD,h,∗ Shao-Xiang Xian, PhD,b,i,∗ and Li-Ming Lu, PhDg

Abstract

Background:

Sepsis-induced myopathy (SIM) is a disease that causes motor dysfunction in patients with sepsis. There is currently no targeted treatment for this disease. Acupuncture has shown considerable efficacy in the treatment of sepsis and muscle weakness. Therefore, our research aims to explore the effects of acupuncture on the improvement of muscle structure and function in SIM patients and on activities of daily living.

Methods:

The ACU-SIM pilot study is a single-center, propensity-score stratified, assessor-blinded, prospective pragmatic controlled trial (pCT) with a 1-year follow-up period. This study will be deployed in a multi-professional critical care department at a tertiary teaching hospital in Guangzhou, China. Ninety-eight intensive care unit subjects will be recruited and assigned to either the control group or the acupuncture group. Both groups will receive basic treatment for sepsis, and the acupuncture group will additionally receive acupuncture treatment. The primary outcomes will be the rectus femoris cross-sectional area, the Medical Research Council sum-score and time-to-event (defined as all-cause mortality or unplanned readmission to the intensive care unit due to invasive ventilation). The activities of daily living will be accessed by the motor item of the Functional Independence Measure. Recruitment will last for 2 years, and each patient will have a 1-year follow-up after the intervention.

Discussion:

There is currently no research on the therapeutic effects of acupuncture on SIM. The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients. This trial will serve as a pilot study for an upcoming multicenter real-world study.

Trial registration:

Chinese Clinical Trials Registry: ChiCTR-1900026308, registered on September 29th, 2019.

Keywords: acupuncture, muscle wasting, pragmatic controlled trial, sepsis