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


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.

SUBMITTER: Tu JF 

PROVIDER: S-EPMC6347816 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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

Tu Jian-Feng JF   Yang Jing-Wen JW   Lin Lu-Lu LL   Wang Tian-Qi TQ   Du Yu-Zheng YZ   Liu Zhi-Shun ZS   Hu Hui H   Zhao Jing-Jie JJ   Yu Xiao-Gang XG   Jia Chun-Sheng CS   Wang Jun J   Wang Tong T   Hou Ya-Quan YQ   Zou Xuan X   Wang Yu Y   Shao Jia-Kai JK   Wang Li-Qiong LQ   Yu Zhang-Sheng ZS   Liu Cun-Zhi CZ  

Trials 20190125 1


<h4>Background</h4>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.<h4>Methods/design</h4>This is a study protocol for a randomised, three-arm, multicentre, clinical trial. A total of 480 patients with KOA will be rando  ...[more]

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