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CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-blind, Randomized Controlled Trial

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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).

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Authors and Affiliations

Authors

Contributions

All authors participated in the design of the study. Shen XY and Lao LX designed the study as principal investigators. Cheng K, Guo MH, Zhao L, and Wu F drafted the manuscript. Tan MT designed the plan for the statistical analysis of the study. Du J, Ding CH and Ge JH are responsible for the recruitment and treatment of patients. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Ke Cheng.

Additional information

Conflict of Interest

CHENG Ke and SHEN Xue-yong have had a patent issued for a type of laser therapy apparatus simulating the infrared radiation spectrum of traditional Chinese moxibustion (China Invention Patent ZL 200910056991.4; issued December 1, 2010).

Supported by National Natural Science Foundation of China (81320108028), National Basic Research Program of China (2015CB554505) and Key Program of the State Administration of Traditional Chinese Medicine of China (ZYSNXD-CCZDXK-07)

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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. 26, 568–576 (2020). https://doi.org/10.1007/s11655-019-2714-6

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