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 ma...
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-018-3138-x |
| _version_ | 1811286988975767552 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jian-Feng Tu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T03:10:36Z |
| format | Article |
| id | doaj.art-452e469a6fda4431ac3795c92aed0481 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T03:10:36Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-452e469a6fda4431ac3795c92aed04812022-12-22T03:05:04ZengBMCTrials1745-62152019-01-0120111010.1186/s13063-018-3138-xEfficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trialJian-Feng Tu0Jing-Wen Yang1Lu-Lu Lin2Tian-Qi Wang3Yu-Zheng Du4Zhi-Shun Liu5Hui Hu6Jing-Jie Zhao7Xiao-Gang Yu8Chun-Sheng Jia9Jun Wang10Tong Wang11Ya-Quan Hou12Xuan Zou13Yu Wang14Jia-Kai Shao15Li-Qiong Wang16Zhang-Sheng Yu17Cun-Zhi Liu18School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese MedicineDepartment of Acupuncture and Moxibustion, Guang’an Men Hospital, China Academy of Chinese Medical SciencesDepartment of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine, Fengtai DistrictDepartment of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical UniversityDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese and Western MedicineHebei University of Chinese MedicineDepartment of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese MedicineDepartment of orthopedics, Institute of Acupuncture and Moxibustion, China Academy Of Chinese Medicine SciencesSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical UniversityDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical UniversitySchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineDepartment of Bioinformatics and Biostatistics, SJTU-Yale Joint Center for Biostatistics, Shanghai Jiao Tong UniversitySchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAbstract 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.http://link.springer.com/article/10.1186/s13063-018-3138-xKnee osteoarthritisElectro-acupunctureManual acupunctureSham acupunctureRandomised controlled trial |
| spellingShingle | 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 Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial Trials Knee osteoarthritis Electro-acupuncture Manual acupuncture Sham acupuncture Randomised controlled trial |
| title | Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial |
| title_full | Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial |
| title_fullStr | Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial |
| title_full_unstemmed | Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial |
| title_short | Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial |
| title_sort | efficacy of electro acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis study protocol for a randomised controlled trial |
| topic | Knee osteoarthritis Electro-acupuncture Manual acupuncture Sham acupuncture Randomised controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-018-3138-x |
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