Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial
单位:[1]School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.[2]Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Xiqing District, Tianjin, China.[3]Department of Acupuncture and Moxibustion, Guang’an Men Hospital, China Academy of Chinese Medical Sciences, Xicheng District, Beijing, China.[4]Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.[5]Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, China.临床科室中医科中医科首都医科大学附属北京友谊医院[6]Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese and Western Medicine, Haidian District, Beijing, China.[7]Hebei University of Chinese Medicine, Shijiazhuang, Heibei, China.[8]Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Dongcheng District, Beijing, China.[9]Department of orthopedics, Institute of Acupuncture and Moxibustion, China Academy Of Chinese Medicine Sciences, Dongcheng District, Beijing, China.[10]Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing, China.[11]Department of Bioinformatics and Biostatistics, SJTU-Yale Joint Center for Biostatistics, Shanghai Jiao Tong University, Minhang District, Shanghai, China.
BackgroundKnee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Although the available evidence for its efficacy is inconclusive, acupuncture is used as an alternative therapy for KOA. The aim of this trial is to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA.Methods/designThis is a study protocol for a randomised, three-arm, multicentre, clinical trial. A total of 480 patients with KOA will be randomly assigned to the electro-acupuncture group, the manual acupuncture group or the sham acupuncture group in a 1:1:1 ratio. All patients will receive 24 sessions over 8weeks. Participants will complete the trial by visiting the research centre at week 26 for a follow-up assessment. The primary outcome is the success rate: the proportion of patients achieving a minimal clinically important improvement, which is defined as 2 points on the numerical rating scale and6 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline. Secondary outcomes include the numerical rating scale, WOMAC score, global patient assessment and quality of life at weeks 4, 8, 16 and 26 after randomisation.DiscussionThis trial may provide high-quality evidence for the efficacy of acupuncture in the treatment of KOA. The results of this study will be published in peer-reviewed journals.Trial registrationClinicalTrials.gov, NCT03274713. Registered on 20 November 2017.
基金:
Beijing Municipal Science & Technology CommissionBeijing Municipal Science & Technology Commission [D171100003217003]; Clinical Medicine Special Development Fund of Beijing Municipal Administration of Hospitals [XMLX201607]
第一作者单位:[1]School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.
通讯作者:
推荐引用方式(GB/T 7714):
Jian-Feng Tu,Jing-Wen Yang,Lu-Lu Lin,et al.Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial[J].TRIALS.2019,20:doi:10.1186/s13063-018-3138-x.
APA:
Jian-Feng Tu,Jing-Wen Yang,Lu-Lu Lin,Tian-Qi Wang,Yu-Zheng Du...&Cun-Zhi Liu.(2019).Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial.TRIALS,20,
MLA:
Jian-Feng Tu,et al."Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial".TRIALS 20.(2019)