CO<sub>2</sub> Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-Blind, Randomized Controlled Trial

Meng-hu GUO; Ling ZHAO; Fan WU; Jiong DU; Chen-huan DING; Jing-hua GE; Ming T TAN; Li-xing LAO; Xue-yong SHEN; Ke CHENG

doi:10.1007/s11655-019-2714-6

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

Original Article | Updated：2021-08-23

- CO₂ Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-Blind, Randomized Controlled Trial
- CO₂ Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-Blind, Randomized Controlled Trial
- Chinese Journal of Integrative Medicine 2020年26卷第8期页码：568-576
- Affiliations：
  
  1.School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
  2.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai (200021), China
  3.Renji Hospital Affiliated to Shanghai Jiaotong University, Shanghai (200127), China
  4.Shanghai Changning Tianshan Traditional Chinese Medicine Hospital, Shanghai (200051), China
  5.Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, D.C. (20057), USA
  6.School of Chinese Medicine, University of Hong Kong, Hong Kong SAR, China
- Author bio：
  
  Correspondence to: Assoc. Prof. CHENG Ke, E-mail:cheng_ker@hotmail.com
- Funds：
  
  National Natural Science Foundation of China(81320108028);National Basic Research Program of China(2015CB554505);Key Program of the State Administration of Traditional Chinese Medicine of China(ZYSNXD-CCZDXK-07)
- DOI：10.1007/s11655-019-2714-6
  中图分类号：
- 纸质出版日期：2020-08-01，
  
  网络出版日期：2020-01-23，
  
  录用日期：2018-11-14
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Meng-hu GUO, Ling ZHAO, Fan WU, 等. CO₂ Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-Blind, Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(8):568-576.

Meng-hu GUO, Ling ZHAO, Fan WU, et al. CO₂ Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-Blind, Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(8):568-576.
Meng-hu GUO, Ling ZHAO, Fan WU, 等. CO₂ Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-Blind, Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(8):568-576. DOI： 10.1007/s11655-019-2714-6.

Meng-hu GUO, Ling ZHAO, Fan WU, et al. CO₂ Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-Blind, Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(8):568-576. DOI： 10.1007/s11655-019-2714-6.

摘要

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). CO

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:

The trial aims to assess the effect and safety of CO

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 CO

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:

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 CO

laser moxibustion in treating knee OA (Trial registration No.: ISRCTN15030019).

关键词

Keywords

Chinese medicinelaser moxibustionknee osteoarthritispainrandomized controlled trial

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DOI：10.1007/s11655-019-2714-6

摘要

Abstract

关键词

Keywords

references

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

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