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Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial.
Trials. 2018 Jul 27; 19(1):403.T

Abstract

BACKGROUND

According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA). This trial aims to determine whether the habitat of moxa floss contributes to the effect of moxibustion and to validate the effectiveness of moxibustion for KOA.

METHODS

This is a three-armed, randomized, double-blinded, sham-controlled trial. A total of 350 patients with moderate to severe primary KOA will be randomly allocated to groups A, B, or C with a 2:2:1 ratio. Moxa stick moxibustion using moxa floss from different habitats will be applied in two experimental groups: group A, moxa floss from the habitat of Qichun County, Hubei Province, China; and group B, moxa floss from the habitat of Nanyang County, Henan Province. Group C will use non-moxa floss for sham moxibustion as control. Patients will be treated for 20 min per session, for three sessions per week for 2 weeks, and followed up for 4 weeks. The primary outcome will be the change from baseline in the pain score of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) at week 2. Secondary outcomes will include a change in the WOMAC pain score at week 6; the visual analogue scale for knee pain, the total WOMAC score, the WOMAC stiffness score, the WOMAC function score, the patient global assessment, and the responder criteria at weeks 2 and 6. Adverse events will be assessed throughout the study.

DISCUSSION

This trial will help to identify the effectiveness of moxibustion for KOA and whether the habitat of moxa floss contributes to the effect of moxibustion.

TRIAL REGISTRATION

Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-16000007 . Registered on 29 February 2016.

Authors+Show Affiliations

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China. hongzhao2005@aliyun.com.State Key Laboratory Breeding Base of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China.Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China.Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China.Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing, China.Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China.Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China.State Key Laboratory Breeding Base of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China.State Key Laboratory Breeding Base of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

30053899

Citation

Xu, Huanfang, et al. "Moxibustion Using Different Habitat Moxa Floss for Moderate to Severe Primary Knee Osteoarthritis: Study Protocol for a Three-armed Randomized, Double-blinded, Sham-controlled Trial." Trials, vol. 19, no. 1, 2018, p. 403.
Xu H, Zhao H, Kang L, et al. Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial. Trials. 2018;19(1):403.
Xu, H., Zhao, H., Kang, L., Huang, S., Shi, Y., Su, W., Han, M., Wang, W., Wang, C., Zhang, Y., & Guo, L. (2018). Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial. Trials, 19(1), 403. https://doi.org/10.1186/s13063-018-2794-1
Xu H, et al. Moxibustion Using Different Habitat Moxa Floss for Moderate to Severe Primary Knee Osteoarthritis: Study Protocol for a Three-armed Randomized, Double-blinded, Sham-controlled Trial. Trials. 2018 Jul 27;19(1):403. PubMed PMID: 30053899.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial. AU - Xu,Huanfang, AU - Zhao,Hong, AU - Kang,Liping, AU - Huang,Shixi, AU - Shi,Yin, AU - Su,Wei, AU - Han,Mingjuan, AU - Wang,Wenyan, AU - Wang,Chunyan, AU - Zhang,Yuan, AU - Guo,Lanping, Y1 - 2018/07/27/ PY - 2017/04/25/received PY - 2018/07/07/accepted PY - 2018/7/29/entrez PY - 2018/7/29/pubmed PY - 2019/3/15/medline KW - Habitat KW - Knee osteoarthritis KW - Moxa floss KW - Moxibustion KW - Randomized controlled trial KW - Study protocol SP - 403 EP - 403 JF - Trials JO - Trials VL - 19 IS - 1 N2 - BACKGROUND: According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA). This trial aims to determine whether the habitat of moxa floss contributes to the effect of moxibustion and to validate the effectiveness of moxibustion for KOA. METHODS: This is a three-armed, randomized, double-blinded, sham-controlled trial. A total of 350 patients with moderate to severe primary KOA will be randomly allocated to groups A, B, or C with a 2:2:1 ratio. Moxa stick moxibustion using moxa floss from different habitats will be applied in two experimental groups: group A, moxa floss from the habitat of Qichun County, Hubei Province, China; and group B, moxa floss from the habitat of Nanyang County, Henan Province. Group C will use non-moxa floss for sham moxibustion as control. Patients will be treated for 20 min per session, for three sessions per week for 2 weeks, and followed up for 4 weeks. The primary outcome will be the change from baseline in the pain score of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) at week 2. Secondary outcomes will include a change in the WOMAC pain score at week 6; the visual analogue scale for knee pain, the total WOMAC score, the WOMAC stiffness score, the WOMAC function score, the patient global assessment, and the responder criteria at weeks 2 and 6. Adverse events will be assessed throughout the study. DISCUSSION: This trial will help to identify the effectiveness of moxibustion for KOA and whether the habitat of moxa floss contributes to the effect of moxibustion. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-16000007 . Registered on 29 February 2016. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/30053899/Moxibustion_using_different_habitat_moxa_floss_for_moderate_to_severe_primary_knee_osteoarthritis:_study_protocol_for_a_three_armed_randomized_double_blinded_sham_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2794-1 DB - PRIME DP - Unbound Medicine ER -