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

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:The 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.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.