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CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-blind, Randomized Controlled Trial.
Chin J Integr Med. 2020 Aug; 26(8):568-576.CJ

Abstract

BACKGROUND

Knee osteoarthritis (OA) is a major cause of disability among the older adults. Few treatments are safe and effective. Moxibustion is commonly used in treating knee OA in Chinese medicine (CM). CO2 Laser moxibustion device is a substitute for traditional moxibustion, which mimics the effects of traditional moxibustion. More data are needed to support its application in knee OA.

OBJECTIVE

ObjectiveThe trial aims to assess the effect and safety of CO2 laser moxibustion in patients with knee osteoarthritis compared with a sham control.

METHODS

This is a protocol for a multicenter, randomized, double-blind, placebo-controlled trial. A total of 392 participants were recruited and assigned to the CO2 laser moxibustion group and sham laser moxibustion group with a 1:1 ratio at 6 outpatient clinics in Shanghai, China. Participants in both groups received treatment at the affected knee(s) at the acupuncture point Dubi (ST 35) and an Ashi point. There were 3 sessions per week for 4 weeks, and an additional 20-week follow-up. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores at week 4. Secondary outcomes were WOMAC function score, stiffness score and overall score, VAS pain, Short-Form heath survey (SF-36), and patients' global assessment. The serum levels of cytokines involved in progress of knee OA were explored. Safety was assessed during the whole trial. Masking effectiveness was assessed by both participants and treatment providers.This is a protocol for a multicenter, randomized, double-blind, placebo-controlled trial. A total of 392 participants were recruited and assigned to the CO2 laser moxibustion group and sham laser moxibustion group with a 1:1 ratio at 6 outpatient clinics in Shanghai, China. Participants in both groups received treatment at the affected knee(s) at the acupuncture point Dubi (ST 35) and an Ashi point. There were 3 sessions per week for 4 weeks, and an additional 20-week follow-up. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores at week 4. Secondary outcomes were WOMAC function score, stiffness score and overall score, VAS pain, Short-Form heath survey (SF-36), and patients' global assessment. The serum levels of cytokines involved in progress of knee OA were explored. Safety was assessed during the whole trial. Masking effectiveness was assessed by both participants and treatment providers.

DISCUSSION

CO2 laser moxibustion device, designed as a substitute for CM moxibustion, is easy to use and control with no choking smoke and smell, and is a plausible method for double-blind research. This study would provide rigorous evidence for the effect and safety of CO2 laser moxibustion in treating knee OA (Trial registration No.: ISRCTN15030019).

Authors+Show Affiliations

School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200021, China.Renji Hospital Affiliated to Shanghai Jiaotong University, Shanghai, 200127, China.Shanghai Changning Tianshan Traditional Chinese Medicine Hospital, Shanghai, 200051, China.Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, D.C., 20057, USA.School of Chinese Medicine, University of Hong Kong, Hong Kong SAR, China.School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. cheng_ker@hotmail.com.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31974753

Citation

Guo, Meng-Hu, et al. "CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for a Multicenter, Double-blind, Randomized Controlled Trial." Chinese Journal of Integrative Medicine, vol. 26, no. 8, 2020, pp. 568-576.
Guo MH, Zhao L, Wu F, et al. CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-blind, Randomized Controlled Trial. Chin J Integr Med. 2020;26(8):568-576.
Guo, M. H., Zhao, L., Wu, F., Du, J., Ding, C. H., Ge, J. H., Tan, M. T., Lao, L. X., Shen, X. Y., & Cheng, K. (2020). CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-blind, Randomized Controlled Trial. Chinese Journal of Integrative Medicine, 26(8), 568-576. https://doi.org/10.1007/s11655-019-2714-6
Guo MH, et al. CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for a Multicenter, Double-blind, Randomized Controlled Trial. Chin J Integr Med. 2020;26(8):568-576. PubMed PMID: 31974753.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-blind, Randomized Controlled Trial. AU - Guo,Meng-Hu, AU - Zhao,Ling, AU - Wu,Fan, AU - Du,Jiong, AU - Ding,Chen-Huan, AU - Ge,Jing-Hua, AU - Tan,Ming T, AU - Lao,Li-Xing, AU - Shen,Xue-Yong, AU - Cheng,Ke, Y1 - 2020/01/23/ PY - 2018/11/14/accepted PY - 2020/1/25/pubmed PY - 2021/1/28/medline PY - 2020/1/25/entrez KW - Chinese medicine KW - knee osteoarthritis KW - laser moxibustion KW - pain KW - randomized controlled trial SP - 568 EP - 576 JF - Chinese journal of integrative medicine JO - Chin J Integr Med VL - 26 IS - 8 N2 - BACKGROUND: Knee osteoarthritis (OA) is a major cause of disability among the older adults. Few treatments are safe and effective. Moxibustion is commonly used in treating knee OA in Chinese medicine (CM). CO2 Laser moxibustion device is a substitute for traditional moxibustion, which mimics the effects of traditional moxibustion. More data are needed to support its application in knee OA. OBJECTIVE: ObjectiveThe trial aims to assess the effect and safety of CO2 laser moxibustion in patients with knee osteoarthritis compared with a sham control. METHODS: This is a protocol for a multicenter, randomized, double-blind, placebo-controlled trial. A total of 392 participants were recruited and assigned to the CO2 laser moxibustion group and sham laser moxibustion group with a 1:1 ratio at 6 outpatient clinics in Shanghai, China. Participants in both groups received treatment at the affected knee(s) at the acupuncture point Dubi (ST 35) and an Ashi point. There were 3 sessions per week for 4 weeks, and an additional 20-week follow-up. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores at week 4. Secondary outcomes were WOMAC function score, stiffness score and overall score, VAS pain, Short-Form heath survey (SF-36), and patients' global assessment. The serum levels of cytokines involved in progress of knee OA were explored. Safety was assessed during the whole trial. Masking effectiveness was assessed by both participants and treatment providers.This is a protocol for a multicenter, randomized, double-blind, placebo-controlled trial. A total of 392 participants were recruited and assigned to the CO2 laser moxibustion group and sham laser moxibustion group with a 1:1 ratio at 6 outpatient clinics in Shanghai, China. Participants in both groups received treatment at the affected knee(s) at the acupuncture point Dubi (ST 35) and an Ashi point. There were 3 sessions per week for 4 weeks, and an additional 20-week follow-up. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores at week 4. Secondary outcomes were WOMAC function score, stiffness score and overall score, VAS pain, Short-Form heath survey (SF-36), and patients' global assessment. The serum levels of cytokines involved in progress of knee OA were explored. Safety was assessed during the whole trial. Masking effectiveness was assessed by both participants and treatment providers. DISCUSSION: CO2 laser moxibustion device, designed as a substitute for CM moxibustion, is easy to use and control with no choking smoke and smell, and is a plausible method for double-blind research. This study would provide rigorous evidence for the effect and safety of CO2 laser moxibustion in treating knee OA (Trial registration No.: ISRCTN15030019). SN - 1672-0415 UR - https://www.unboundmedicine.com/medline/citation/31974753/CO2_Laser_Moxibustion_for_Knee_Osteoarthritis:_Study_Protocol_for_A_Multicenter_Double_blind_Randomized_Controlled_Trial_ L2 - https://dx.doi.org/10.1007/s11655-019-2714-6 DB - PRIME DP - Unbound Medicine ER -