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.

Efficacy of stimulating Mingmen(GV4) and Guanyuan(CV4) on kidney Yang deficiency in rat model: laser irradiation vs traditional moxibustion

OBJECTIVE: To investigate the effect of 10.6-μm laser moxibustion(LM) and traditional moxibustion(TM) on kidney Yang deficiency(KYD) model rats. METHODS: Forty rats were randomly divided into normal, model, 10.6-μm LM, and TM groups. KYD was induced through intramuscular hydrocortisone injections. RESULTS: Hydrocortisone injections decreased the body weight, activity, and temperature and induced changes in the organ coefficients. Compared with the model group, TM and LM treatment prevented body weight loss and improved organ coefficients after treatment(P < 0.05), while the body weight remained lower compared to the normal group(P < 0.01). Additionally, LM and TM significantly increased the levels of urine 17-hydroxycorticosteroid(17-OHCS) compared with the model group(P < 0.01). The LM and TM groups showed a greater distance travelled across the central area, time spent in the central area, and 5-min total distance than the model group in the open field test(P < 0.01). The model group had the lowest anal or surface temperature(P < 0.05);there were no differences among the other three groups(P > 0.05). TM treatment increased the temperature of Mingmen(GV4) and Guanyuan(CV4) compared to the model group(P < 0.05, P < 0.01). LM treatment increased Mingmen(GV4) temperature(P < 0.05), while there were no obvious differences in Guanyuan(CV4) temperature compared with the normal group before and after treatment(P > 0.05). There was a positive correlation between Mingmen(GV4)/Guanyuan(CV4) temperature and 17-OHCS levels. CONCLUSIONS: LM and TM treatment can improve KYD symptoms, and acupoint temperature changes may be an objective indicator of KYD.