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, Zhangsheng Yu, Cun Zhi Liu

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number79
JournalTrials
Volume20
Issue number1
DOIs
StatePublished - Jan 25 2019
Externally publishedYes

Fingerprint

Knee Osteoarthritis
Acupuncture
Randomized Controlled Trials
Acupuncture Therapy
Ontario
Complementary Therapies
Random Allocation
Osteoarthritis
Multicenter Studies
Quality of Life
Clinical Trials
Research

Keywords

  • Electro-acupuncture
  • Knee osteoarthritis
  • Manual acupuncture
  • Randomised controlled trial
  • Sham acupuncture

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis : Study protocol for a randomised controlled trial. / Tu, Jian Feng; Yang, Jing Wen; Lin, Lu Lu; Wang, Tian Qi; Du, Yu Zheng; Liu, Zhi Shun; Hu, Hui; Zhao, Jing Jie; Yu, Xiao Gang; Jia, Chun Sheng; Wang, Jun; Wang, Tong; Hou, Ya Quan; Zou, Xuan; Wang, Yu; Shao, Jia Kai; Wang, Li Qiong; Yu, Zhangsheng; Liu, Cun Zhi.

In: Trials, Vol. 20, No. 1, 79, 25.01.2019.

Research output: Contribution to journalArticle

Tu, JF, Yang, JW, Lin, LL, Wang, TQ, Du, YZ, Liu, ZS, Hu, H, Zhao, JJ, Yu, XG, Jia, CS, Wang, J, Wang, T, Hou, YQ, Zou, X, Wang, Y, Shao, JK, Wang, LQ, Yu, Z & Liu, CZ 2019, 'Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: Study protocol for a randomised controlled trial', Trials, vol. 20, no. 1, 79. https://doi.org/10.1186/s13063-018-3138-x
Tu, Jian Feng ; Yang, Jing Wen ; Lin, Lu Lu ; Wang, Tian Qi ; Du, Yu Zheng ; Liu, Zhi Shun ; Hu, Hui ; Zhao, Jing Jie ; Yu, Xiao Gang ; Jia, Chun Sheng ; Wang, Jun ; Wang, Tong ; Hou, Ya Quan ; Zou, Xuan ; Wang, Yu ; Shao, Jia Kai ; Wang, Li Qiong ; Yu, Zhangsheng ; Liu, Cun Zhi. / Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis : Study protocol for a randomised controlled trial. In: Trials. 2019 ; Vol. 20, No. 1.
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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.",
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T2 - Study protocol for a randomised controlled trial

AU - Tu, Jian Feng

AU - Yang, Jing Wen

AU - Lin, Lu Lu

AU - Wang, Tian Qi

AU - Du, Yu Zheng

AU - Liu, Zhi Shun

AU - Hu, Hui

AU - Zhao, Jing Jie

AU - Yu, Xiao Gang

AU - Jia, Chun Sheng

AU - Wang, Jun

AU - Wang, Tong

AU - Hou, Ya Quan

AU - Zou, Xuan

AU - Wang, Yu

AU - Shao, Jia Kai

AU - Wang, Li Qiong

AU - Yu, Zhangsheng

AU - Liu, Cun Zhi

PY - 2019/1/25

Y1 - 2019/1/25

N2 - 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.

AB - 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.

KW - Electro-acupuncture

KW - Knee osteoarthritis

KW - Manual acupuncture

KW - Randomised controlled trial

KW - Sham acupuncture

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