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Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial.
BMJ Open. 2017 04 12; 7(4):e012879.BO

Abstract

INTRODUCTION

Knee osteoarthritis is a common form of arthritis in elderly patients that is characterised by pain and functional limitation. Moxibustion has been employed to relieve chronic pain as an alternative therapy for knee osteoarthritis. However, the evidence of its efficacy is equivocal due to the low methodological quality in most clinical studies. Therefore, we are performing a double-blinded, double-placebo, randomised controlled trial to evaluate the efficacy of moxibustion in participants with knee osteoarthritis.

METHODS AND ANALYSIS

This is a multicentre, double-blinded, double-placebo, randomised controlled clinical trial. 144 eligible participants with knee osteoarthritis will be randomly assigned to two different groups in a 1:1 ratio. Participants in the moxibustion group will undergo active moxibustion plus placebo gel, whereas participants in the control group will receive diclofenac sodium gel plus placebo moxibustion. Each participant will receive 12 sessions of active/placebo moxibustion at three acupoints (ST35, ST36 and EX-LE4) as well as 2 months of follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee will be applied three times per day for 4 weeks. The primary outcome measure will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change at the end of the intervention period from baseline. The secondary outcome measures include changes of other subscales (pain, stiffness and function) of WOMAC, visual analogue scale and patient globalassessment. The safety of moxibustion and diclofenac sodium gel will be assessed at every visit.

ETHICS AND DISSEMINATION

This trial has been approved by the Sichuan Regional Ethics Review Committee (permission number: 2015KL-014). The results of this study are expected to provide clinical evidence on the efficacy of moxibustion for pain relief and physical function improvement in patients with knee osteoarthritis. The findings will be submitted for publication in peer-reviewed medical journals and presented at relevant academic conferences.

TRIAL REGISTRATION NUMBER

NCT02769572.

Authors+Show Affiliations

School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China tangyong@cdutcm.edu.cn.School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28404609

Citation

Zhou, Jian-Ying, et al. "Moxibustion Versus Diclofenac Sodium Gel for the Treatment of Knee Osteoarthritis: a Study Protocol for a Double-blinded, Double-placebo, Randomised Controlled Trial." BMJ Open, vol. 7, no. 4, 2017, pp. e012879.
Zhou JY, Luo L, Zhu LL, et al. Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial. BMJ Open. 2017;7(4):e012879.
Zhou, J. Y., Luo, L., Zhu, L. L., Yin, H. Y., Wu, Q., Peng, J. X., Zhang, C. S., Lv, P., Tang, Y., & Yu, S. G. (2017). Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial. BMJ Open, 7(4), e012879. https://doi.org/10.1136/bmjopen-2016-012879
Zhou JY, et al. Moxibustion Versus Diclofenac Sodium Gel for the Treatment of Knee Osteoarthritis: a Study Protocol for a Double-blinded, Double-placebo, Randomised Controlled Trial. BMJ Open. 2017 04 12;7(4):e012879. PubMed PMID: 28404609.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial. AU - Zhou,Jian-Ying, AU - Luo,Ling, AU - Zhu,Lin-Lin, AU - Yin,Hai-Yan, AU - Wu,Qiaofeng, AU - Peng,Jia-Xi, AU - Zhang,Cheng-Shun, AU - Lv,Peng, AU - Tang,Yong, AU - Yu,Shu-Guang, Y1 - 2017/04/12/ PY - 2017/4/14/entrez PY - 2017/4/14/pubmed PY - 2017/9/12/medline KW - Moxibustion KW - knee osteoarthritis KW - randomized controlled trial KW - study protocol SP - e012879 EP - e012879 JF - BMJ open JO - BMJ Open VL - 7 IS - 4 N2 - INTRODUCTION: Knee osteoarthritis is a common form of arthritis in elderly patients that is characterised by pain and functional limitation. Moxibustion has been employed to relieve chronic pain as an alternative therapy for knee osteoarthritis. However, the evidence of its efficacy is equivocal due to the low methodological quality in most clinical studies. Therefore, we are performing a double-blinded, double-placebo, randomised controlled trial to evaluate the efficacy of moxibustion in participants with knee osteoarthritis. METHODS AND ANALYSIS: This is a multicentre, double-blinded, double-placebo, randomised controlled clinical trial. 144 eligible participants with knee osteoarthritis will be randomly assigned to two different groups in a 1:1 ratio. Participants in the moxibustion group will undergo active moxibustion plus placebo gel, whereas participants in the control group will receive diclofenac sodium gel plus placebo moxibustion. Each participant will receive 12 sessions of active/placebo moxibustion at three acupoints (ST35, ST36 and EX-LE4) as well as 2 months of follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee will be applied three times per day for 4 weeks. The primary outcome measure will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change at the end of the intervention period from baseline. The secondary outcome measures include changes of other subscales (pain, stiffness and function) of WOMAC, visual analogue scale and patient globalassessment. The safety of moxibustion and diclofenac sodium gel will be assessed at every visit. ETHICS AND DISSEMINATION: This trial has been approved by the Sichuan Regional Ethics Review Committee (permission number: 2015KL-014). The results of this study are expected to provide clinical evidence on the efficacy of moxibustion for pain relief and physical function improvement in patients with knee osteoarthritis. The findings will be submitted for publication in peer-reviewed medical journals and presented at relevant academic conferences. TRIAL REGISTRATION NUMBER: NCT02769572. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/28404609/Moxibustion_versus_diclofenac_sodium_gel_for_the_treatment_of_knee_osteoarthritis:_a_study_protocol_for_a_double_blinded_double_placebo_randomised_controlled_trial_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=28404609 DB - PRIME DP - Unbound Medicine ER -