Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial

Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao, Li-Qiong Wang, Zhang-Sheng Yu, Cun-Zhi Liu, Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao, Li-Qiong Wang, Zhang-Sheng Yu, Cun-Zhi Liu

Abstract

Background: Knee 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/design: This 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 8 weeks. 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 and ≥6 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.

Discussion: This 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 registration: ClinicalTrials.gov, NCT03274713 . Registered on 20 November 2017.

Trial registration: ClinicalTrials.gov NCT03366363.

Keywords: Electro-acupuncture; Knee osteoarthritis; Manual acupuncture; Randomised controlled trial; Sham acupuncture.

Conflict of interest statement

Ethics approval and consent to participate

This trial has been approved by the research ethical committees of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2017BL-077-01), Beijing Friendship Hospital Affiliated to Capital Medical University, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Guang’an Men’s Hospital Affiliated to the China Academy of Chinese Medical Sciences, Hospital of Acupuncture and Moxibustion Affiliated to the China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese and Western Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and Affiliated Hospital of Hebei University of Chinese Medicine. Written informed consent will be obtained from all patients prior to their enrolment in the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram. EA electro-acupuncture, KOA knee osteoarthritis, MA manual acupuncture, SA sham acupuncture
Fig. 2
Fig. 2
Locations of acupoints and non-acupoints. Dark blue circles: Obligatory acupoints used for all patients in the EA and MA groups. Yellow circles: Adjunct acupoints used for patients with yangming meridian syndrome. Green circles: Adjunct acupoints used for patients with three-yin meridian syndrome. Light blue circles: Adjunct acupoints used for patients with taiyang meridian syndrome. Purple circles: Adjunct acupoints used for patients with shaoyang meridian syndrome. Red circles: Non-acupoints used for patients in the SA group. EA electro-acupuncture, MA manual acupuncture, SA sham acupuncture
Fig. 3
Fig. 3
Schedule of enrollment, intervention and assessments (SPIRIT Figure) AFT, after the first treatment; WOMAC Western Ontario and McMaster Universities Osteoarthritis Index; SF-12 12-item Short Form Health Survey

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