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

Guo, Menghu; Zhao, Ling; Wu, Fan; Du, Jiong; Ding, Chenhuan; Jing-hua, GE; Tan, Ming; Lao, Lixing; Shen, Xueyong; Cheng, Ke

doi:10.1007/s11655-019-2714-6

Cited by 7 publications

(6 citation statements)

References 16 publications

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“…You might feel any sensations (e.g., heat, cold, no feeling, or else) from this device. However, neither of the two methods can guarantee the curative effect…I have been told that I may be assigned randomly in 10.6 μm LM group or non-10.6 μm LM group [ 39 ].” Besides, the two groups of patients will be treated in separate rooms or treatment time to avoid communication among patients. Therefore, patients, researcher screening patients, device operators, outcome assessors, data entry researchers, and statistical personnel will be blinded to the treatment allocation.…”

Section: Methodsmentioning

confidence: 99%

“…Serious adverse effects are reported to Medical Ethics Committee. The patients will answer questionnaire assessing the safety of the treatment at the end of LM treatment (week 4): “What do you think of the safety of laser therapy: safe, relatively safe, unsafe, and very unsafe” [ 39 ].…”

Section: Methodsmentioning

confidence: 99%

Section: Randomization and Blindingmentioning

confidence: 99%

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10.6-μm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial

Lin

Chen

et al. 2022

Trials

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Background Diabetic peripheral neuropathy (DPN) is the most common chronic neurological complication. It is the main cause of disability in diabetes mellitus (DM) patients and seriously affects the quality of life of patients. Pharmacological treatments always associate with limited efficacy and adverse effects. Moxibustion has been recommended to treat DPN as an adjuvant therapy to conventional medical treatment to accelerate alleviation of the symptoms of DPN. 10.6-μm laser moxibustion (LM), whose wavelength is close to the peak of infrared radiation spectrum of the traditional moxibustion as well as human acupoints, produces the thermal effect similar with moxibustion but with no smoke or smell. The purpose of this sham controlled clinical trial is to determine the effect and safety of 10.6-μm LM as adjuvant therapy in patients with DPN. Methods This is a protocol for a randomized, double-blind, sham-controlled trial. One hundred fourteen patients meeting the inclusion and exclusion criteria will be recruited and randomly assigned to the LM group or the sham LM group with a 1:1 allocation ratio. Patients in both groups will receive a basic integrated treatment of Chinese and Western medicine and a total of 12 sessions of true or sham LM treatments over 4 weeks with 3 sessions a week. The primary outcome is nerve conduction velocity (NCV), and the secondary outcomes include Michigan Neuropathy Screening Instrument (MNSI) scores, Diabetes-Specific Quality of Life (DSQL) scores, blood rheology parameters, and assessments of safety and blinding. Outcome measures will be collected at baseline, 2 weeks after treatment, the end of LM treatments (4 weeks), and 4, 8 weeks after the end of LM treatment (8, 12weeks). Discussion This study will be conducted to compare the efficacy of LM versus sham LM combined with medical treatment. 10.6-μm LM may alleviate symptoms, improve quality of life, and reduce the dosage of drugs as well as avoid causing serious side effects. Trial registration Chinese Clinical Trial Registry ChiCTR2000029329. Registered on 25 January 2020.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Randomization and Blindingmentioning

confidence: 99%

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10.6-μm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial

Lin

Chen

et al. 2022

Trials

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“…As a traditional Chinese external therapy, moxibustion involves burning mugwort, called ai-ye in China, to produce a warm effect on the meridians, acupoints, and surface areas of the body (15,16). Moxibustion plays a key role in regulating the innate yin and yang in the body, therefore its application is very common in many disorders, such as knee osteoarthritis, irritable bowel syndrome, cancer-related fatigue, coronavirus disease 2019, and alleviating side effects of chemotherapy or radiotherapy in cancer patients (17)(18)(19)(20)(21)(22). Nevertheless, as an important part of acupuncture, up to nowadays, moxibustion therapy has not been widely promoted worldwide.…”

Section: Introductionmentioning

confidence: 99%

Moxibustion for treating patients with post-stroke depression: a systematic review and meta-analysis

Guo¹,

Zhao²,

Li³

et al. 2022

Ann Palliat Med

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Background: To assess the effectiveness and safety of moxibustion for post-stroke depression (PSD). Methods: A search was conducted in the following English and Chinese databases: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature (CBM), VIP and Wanfang. The outcomes included Hamilton Depression Rating Scale (HAMD), effective rate, and Modified Edinburgh-Scandinavian Stroke Scale (MESSS) scale. The formulation of search strategy, data extraction, and quality evaluation of involved studies was performed according to Cochrane handbook guidelines. The software RevMan 5.4 and Stata 16 were used for data analysis. The evidence quality of each outcome was evaluated by GRADEpro guideline development tool (GDT).Results: A total of 14 trials with 863 participants were included. A certain risk of bias of unclear or high was detected in the included studies. Compared with the control group, adding moxibustion could change

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“…These studies have involved options such as near-infrared laser, electric moxibustion, point electrothermal moxibustion, and ultrasonic devices. 9 , 11 , 12 , 13 , 14 However, these studies did not provide detailed information about the process of fabricating UTs, the acoustic fields generated by the ultrasonic moxibustion device (UMD), ultrasonic systems needed to activate the ultrasonic transducers, or the design parameters of the UMD.…”

Section: Introductionmentioning

confidence: 99%

Ultrasonic device developed for non-invasive moxibustion therapy

Kim

Hwang

Ryu

et al. 2021

Integrative Medicine Research

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Background Recently, some adverse effects of moxibustion has been reported such as burns, smoke, allergies, and so on. To overcome the adverse effects of traditional moxibustion, an ultrasonic moxibustion device (UMD) was designed, simulated, fabricated, and tested. The objective of this study is to provide detailed information about the main design parameters, simulation outcome, and performance-test results. Methods The main components of the UMD are a 1-MHz ultrasonic transducer (UT) with concave lens, and its applicator. The acoustic pressure and temperature distribution of the UT was simulated and described graphically using COMSOL software, which is based on the finite element method (FEM). Experimental verification of the temperature distribution was performed on the skin of pork. The temperature-change profiles of pork in relation to increase of therapy time were obtained at an unfocused point (2 mm) and at a focal distance of 13 mm. For the performance test, moxibustion therapy was conducted on the abdominal skin of mice for 120 min using the new UMD and its histological images were acquired to analyze the skin-tissue damage. Results The FEM simulation of temperature distribution and acoustic pressure agreed with the experimental outcome. Histological images showed that there was no skin-tissue damage to the mouse abdomens after therapy. The results clearly show that the newly developed UMD can overcome the disadvantages of traditional moxibustion therapy and achieve the proposed design parameters. Conclusion The FEM simulation and performance tests provided valuable information about developing future UMDs. In addition, its performance can be compared with traditional moxibustion therapy for future study.

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

Cited by 7 publications

References 16 publications

10.6-μm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial

10.6-μm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial

Moxibustion for treating patients with post-stroke depression: a systematic review and meta-analysis

Ultrasonic device developed for non-invasive moxibustion therapy

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