Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial
Abstract Background Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous...
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| Format: | Article |
| Language: | English |
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BMC
2017-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1846-2 |
| _version_ | 1811284224673579008 |
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| author | Lin-lin Zhu Jian-ying Zhou Ling Luo Xiang Wang Jia-xi Peng Sha-sha Chen Hai-Yan Yin Qiao-Feng Wu Cheng-shun Zhang Peng Lv Yong Tang Shu-guang Yu |
| author_facet | Lin-lin Zhu Jian-ying Zhou Ling Luo Xiang Wang Jia-xi Peng Sha-sha Chen Hai-Yan Yin Qiao-Feng Wu Cheng-shun Zhang Peng Lv Yong Tang Shu-guang Yu |
| author_sort | Lin-lin Zhu |
| collection | DOAJ |
| description | Abstract Background Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative. However, whether smoke-free moxibustion would display a similar efficacy to that of conventional moxibustion still remains unclear. Therefore, this randomized controlled trial attempts to investigate the difference of efficacy between conventional moxibustion and smoke-free moxibustion in patients with KOA. Methods/design This is a multicenter, randomized, single-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated to two groups (conventional moxibustion group and smoke-free moxibustion group) in seven hospitals in China. Participants will receive 12 sessions of moxibustion treatment at three acupoints (EX-LE4, ST35, and ST36) over a period of 4 weeks (3 sessions per week). A smoke-removing device is placed at the top of the moxibustion device for the smoke-free moxibustion group (n = 69), while the conventional moxibustion group (n = 69) is treated with traditional moxibustion. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. Secondary outcomes include the visual analog scale VASand Patient Global Assessment scores. Follow-up measurements will be performed on the 8th and 12th weeks after random allocation. Discussion This study will contribute to providing a solid foundation for the selection of moxibustion in clinical application as well as future research in moxibustion therapy. Trial registration ClinicalTrials.gov, NCT02772055 . Registered on 12 May 2016. |
| first_indexed | 2024-04-13T02:25:28Z |
| format | Article |
| id | doaj.art-27f800c2e016468abac7d832717392b1 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T02:25:28Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-27f800c2e016468abac7d832717392b12022-12-22T03:06:47ZengBMCTrials1745-62152017-04-011811810.1186/s13063-017-1846-2Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trialLin-lin Zhu0Jian-ying Zhou1Ling Luo2Xiang Wang3Jia-xi Peng4Sha-sha Chen5Hai-Yan Yin6Qiao-Feng Wu7Cheng-shun Zhang8Peng Lv9Yong Tang10Shu-guang Yu11Chengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduChengdu University of Traditional Chinese Medicine ChengduAbstract Background Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative. However, whether smoke-free moxibustion would display a similar efficacy to that of conventional moxibustion still remains unclear. Therefore, this randomized controlled trial attempts to investigate the difference of efficacy between conventional moxibustion and smoke-free moxibustion in patients with KOA. Methods/design This is a multicenter, randomized, single-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated to two groups (conventional moxibustion group and smoke-free moxibustion group) in seven hospitals in China. Participants will receive 12 sessions of moxibustion treatment at three acupoints (EX-LE4, ST35, and ST36) over a period of 4 weeks (3 sessions per week). A smoke-removing device is placed at the top of the moxibustion device for the smoke-free moxibustion group (n = 69), while the conventional moxibustion group (n = 69) is treated with traditional moxibustion. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. Secondary outcomes include the visual analog scale VASand Patient Global Assessment scores. Follow-up measurements will be performed on the 8th and 12th weeks after random allocation. Discussion This study will contribute to providing a solid foundation for the selection of moxibustion in clinical application as well as future research in moxibustion therapy. Trial registration ClinicalTrials.gov, NCT02772055 . Registered on 12 May 2016.http://link.springer.com/article/10.1186/s13063-017-1846-2Moxa smokeMoxibustionKnee osteoarthritisRandomized controlled trialProtocol |
| spellingShingle | Lin-lin Zhu Jian-ying Zhou Ling Luo Xiang Wang Jia-xi Peng Sha-sha Chen Hai-Yan Yin Qiao-Feng Wu Cheng-shun Zhang Peng Lv Yong Tang Shu-guang Yu Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial Trials Moxa smoke Moxibustion Knee osteoarthritis Randomized controlled trial Protocol |
| title | Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial |
| title_full | Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial |
| title_fullStr | Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial |
| title_full_unstemmed | Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial |
| title_short | Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial |
| title_sort | comparison of the efficacy between conventional moxibustion and smoke free moxibustion on knee osteoarthritis study protocol of a randomized controlled trial |
| topic | Moxa smoke Moxibustion Knee osteoarthritis Randomized controlled trial Protocol |
| url | http://link.springer.com/article/10.1186/s13063-017-1846-2 |
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