Effect of auricular electroacupuncture combined with body acupuncture in improving the consciousness of patients after traumatic brain injury Study protocol for a randomized controlled trial
机构:[1]Department of Acupuncture and Rehabilitation, GuangDong Second Hospital of Traditional Chinese Medicine,Guangdong, China[2]Department of Acupuncture and Rehabilitation,Guangdong, China. Guangzhou University of Chinese Medicine,Guangdong, China.[3]Department of Rehabilitation Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China.大德路总院康复科大德路总院康复科广东省中医院
Background: Traumatic brain injury (TBI) has become a major cause of morbidity and mortality both in China and abroad. Disorders of consciousness following severe TBI is a common refractory complication, resulting in difficult rehabilitation and poor life quality. However, effective therapeutic approaches remain limited. Although acupuncture has been widely applied in the treatment of neurological disorders in China, its efficacy and safety for consciousness recovery remain to be elucidated. Methods: Here, we conduct a study design and protocol of a randomized, blinded, controlled study to evaluate the efficacy and safety of electroacupuncture at auricular acupoints "heart" and "brainstem" combined with body acupuncture in the consciousness recovery of patients with TBI. A total of 80 patients with initial Glasgow coma scale score between 3 and 8 points will be recruited in the trial and randomized into intervention (combined application of auricular electroacupuncture and body acupuncture) group or control (conventional treatment) group. Patients in the intervention group will receive electroacupuncture at bilateral auricular acupoints "heart" and "brainstem" (4 points in total) combined with body acupuncture in addition to conventional treatment while patients in the control group will receive conventional treatment alone for 8 weeks. The primary outcomes are changes of Glasgow coma scale score and mismatch negativity of event-related brain potentials at baseline after 4 weeks after the final treatment and 4 weeks after the final treatment. The secondary outcome measures will be changes of Barthel and FuglMeyer scores at baseline after 4 weeks after the final treatment and 4 weeks after the final treatment. The safety will also be assessed by monitoring the incidence of adverse events and changes in vital signs during the study. Discussion: Results from this trial will significantly support the application of auricular acupuncture and body acupuncture in the consciousness recovery of patients with severe TBI. If found to be effective and safe, auricular acupuncture combined with body acupuncture will be a valuable complementary option for comatose patients with TBI.
基金:
National Science Foundation for Young Scientists of China [81704179]
第一作者机构:[1]Department of Acupuncture and Rehabilitation, GuangDong Second Hospital of Traditional Chinese Medicine,Guangdong, China
共同第一作者:
通讯作者:
通讯机构:[1]Department of Acupuncture and Rehabilitation, GuangDong Second Hospital of Traditional Chinese Medicine,Guangdong, China[3]Department of Rehabilitation Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China.[*1]Department of Rehabilitation Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China[*2]Department of Acupuncture and Rehabilitation, GuangDong Second Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China
推荐引用方式(GB/T 7714):
Liu Tong,Lu Yanqing,Yu Jiani,et al.Effect of auricular electroacupuncture combined with body acupuncture in improving the consciousness of patients after traumatic brain injury Study protocol for a randomized controlled trial[J].MEDICINE.2019,98(30):doi:10.1097/MD.0000000000016587.
APA:
Liu, Tong,Lu, Yanqing,Yu, Jiani,Kuang, Weichuan,Wang, Xiaoyin...&Liu, Yue.(2019).Effect of auricular electroacupuncture combined with body acupuncture in improving the consciousness of patients after traumatic brain injury Study protocol for a randomized controlled trial.MEDICINE,98,(30)
MLA:
Liu, Tong,et al."Effect of auricular electroacupuncture combined with body acupuncture in improving the consciousness of patients after traumatic brain injury Study protocol for a randomized controlled trial".MEDICINE 98..30(2019)