• Journal of Acupuncture Research
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• v.23 no.6
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• pp.239-254
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• 2006

The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

• Journal of Acupuncture Research
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• v.29 no.5
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• pp.127-137
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• 2012

Objectives : The purpose of this study is to review on current status of use and measurement condition of heart rate variability(HRV) by reviewing clinical studies published in journal of Korean medicine registered Korea citraion index(KCI). Methods : One hundred twenty articles were found by searching the representative Korean databases. At first analysis was performed by current status of use(journal, academic field of corresponing author, purpose of study, disease of subject, HRV measurement devices, intervention methods and tests compared to HRV). At second analysis was performed by measurement condition(uncontrolled study, relaxation before measurement, measurement position, measurement place, measurement time period and restriction of smoking, alcohol, caffeine, meal). Results : The analysis showed that department of acupuncture & moxibustion, department of oriental neuropsychiatry are major part in journal & academic field. The purpose of study were classified under studies to verify therapeutic effect on normal subject(39%), to verify therapeutic effect on the patients(8%), to investigate characteristics of the patients(34%) and to be compared with other test(19%). Disease of subject & measurement devices in article were so various. Major intervention methods were acupuncture(61.4%), mind-body intervention(19.2%). Studies that measurement condition were not controlled were relax time(24%), measurement position(19%), measurement place(26%), measurement time period(91%) and restriction of smoking, alcohol, caffeine, meal(49%). Conclusions : This study showed that current status of use of HRV is widespread in Korean medicine but more controlled measurement conditon are needed to get more reliable result from clinical studies and to improve diagnosis and treatment of Korean medicine.

• Journal of Acupuncture Research
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• v.33 no.4
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• pp.15-31
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• 2016

Objectives : The aim of this study is to review the instruments used to assess patient condition and the effects of Korean medical treatment for patients injured in traffic accidents in clinical studies in the Korean medical field published in South Korea. Methods : A literature study was performed, and clinical studies on patients injured in traffic accidents visiting Korean medical clinics or hospitals were examined. Data about chief complaints, tools used to assess either patients' condition or the effectiveness of Korean medical treatment, and time point of assessment were extracted. The studies were classified according to symptom. The use-frequency and the parent category of the assessment tools were also analyzed. Results : 78 studies were selected and classified into 5 categories based on the chief complaints, neck pain, lower back pain, headache, psychological symptoms and unspecified symptoms. Various scales were used to report the patient's pain severity, and functional or psychological status resulting from traffic accidents. Pain index, in particular VAS, was most frequently used and a few mechanical instruments and Korean medicinal assessment tools were mentioned. Conclusion : Most instruments used in Korean medicine clinical studies on patients injured in traffic accidents are self-reported tools. To assess both the patient's condition precisely and the effectiveness of Korean medical treatment on patients injured in traffic accidents, more appropriate and unified tools should be designed that consider pain, functional disability, psychological status and objective assessments measured by devices together.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.4
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• pp.430-439
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• 2014

This study was performed to assess the perception and needs of the traditional Korean Medical Equipment (KME) in clinic. We conducted survey research among 15,550 traditional Korean medical doctors (KMD) responded to e-mail during 2 weeks. 899 participants the survey, consisting of questions regarding 'number of devices of the KME' and 'solution and improvement plan of the KME'. The participants were asked to choose their ranking of problems of the KME and also put a check mark in the column that the reasons for this choice. As results, final scores in priority ranking medical devices were derived in 7 categories. Physical therapy equipment and acupuncture treatment devices were included in high ranks. 42.8 % of the participants responded that the diagnostic medical devices seemed important in clinics and 67.4 % of the participants indicated that the therapeutic medical devices seemed to important in clinics. The identified problems of KME were 'low reproducibility and reliability of a diagnosis result (24.8%)' and 'uncertain validity of a diagnostic medical devices (20.5%)'. The improvement plan of the problems were 'to establish the law for using the medical devices (26.6%)' and 'evaluation of validity of the KME (26.2%)'. A survey of KMD revealed the condition of KME's number of devices and the solution plan for the problem of several KMEs. Understanding the needs of KMD could probably contribute to the research and development of KMEs in the future.

• Journal of Acupuncture Research
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• v.33 no.4
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• pp.65-72
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• 2016

Objectives : While neck pain is highly prevalent in Korea, studies examining its Korean medical treatment are currently lacking. The aim of this study was to assess current Korean medical treatment practice patterns for neck pain. Methods : A preliminary questionnaire was developed to investigate current practice patterns of neck pain and cervical intervertebral disc displacement (IDD) treatment, and underwent further revision through external review. The final questionnaire was distributed as a web-based survey to 18,289 potential respondents by email. Results : The response rate was 3.34 %. Most participants replied that they received multiple Korean medicine interventions for neck pain treatment consisting of such methods as acupuncture, wet cupping, interferential current therapy and electroacupuncture. A total of 378 respondents acknowledged that diagnostic testing was needed for neck pain treatment. The most commonly used Korean Standard Classification of Diseases (KCD) principal diagnosis code for neck pain was M542, and for cervical IDD was M501. Conclusion : This survey study helps determine current practice patterns of neck pain, and recognizes the need for use of diagnostic devices in neck pain treatment. These results are further anticipated to provide basic data for clinical practice guidelines (CPGs) and future studies using Korean National Health Insurance and Health Insurance Review & Assessment Service data.

• Journal of Acupuncture Research
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• v.27 no.1
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• pp.75-86
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• 2010

Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{\circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.9 no.1
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• pp.125-130
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• 2005

Background and purpose: We evaluated the reliability of two electrodermal measurement devices on meridian skin areas; Electro Acupuncture according to Dr. Voll (EAV) method and newly developed MIR-1. Methods: Eighteen volunteers were tested repeatedly on the same condition with each device. To explore the intra-rater, inter-rater, and test-retest reliabilities, one rater tested each subject twice in succession, then the other rater tested the subject in a row. Finally, retests on the subjects with each device were performed 1 week later. The reliability was determined by Pearson correlation and intraclass correlation statistics. Results: EAV method showed poor reliability, while MIR-1 showed good reliability. Conclusion: It is suggested that further research on the reliability and useful device in both fields of clinical practice and biomedical research.

• Korean Journal of Acupuncture
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• v.40 no.4
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• pp.194-205
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• 2023

Objectives : This study investigated the current utilization status of thermotherapy devices in Korean medicine (KM) institutions and identified areas for improvement and further development, as perceived by KM doctors (KMDs). Methods : An online survey was conducted, targeting KMDs primarily engaged in clinical patient care. The questionnaire included items about respondents' clinical practices, the extent of thermotherapy device usage, their opinions on these devices, and perceived improvement needs. The collected data underwent quantitative analysis. Results : From the 1,025 respondents, data from 862 respondents who provided complete responses were analyzed. On average, respondents utilized thermotherapy treatments for 80% of their patients. Infrared (IR) phototherapy unit, electrical moxibustion apparatus, and heater-based thermotherapy devices were predominantly owned by respondents, with IR being the most frequently used. The average satisfaction score for current thermotherapy devices was 79. A significant concern raised was the necessity for improved health insurance coverage and efficacy evaluation. Conclusions : This research has confirmed that the extensive use of thermotherapy devices by KMDs in treating primarily musculoskeletal and gastrointestinal ailments - common conditions among patients in KM institutions. The main areas identified for improvement encompass safety, cost-effectiveness, and device efficacy. Future enhancements in thermotherapy devices should address these crucial aspects.

• Korean Journal of Acupuncture
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• v.40 no.4
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• pp.156-168
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• 2023

Objectives : This study aimed to determine the status of thermal stimulation devices approved in Korea for medical applications over the past 10 years, and based on this, to obtain insight for future thermal treatment in Korean medical institutions. Methods : We searched the item classification list entitled "Regulations on Medical Device Items and Rating by Item" from the Ministry of Food and Drug Safety Notice No. 2021-24, 2021 (Enforced March 19, 2021; www.mfds.go.kr) for individually licensed heaters using the terms "heat" and "heating". Results : We identified 17 items of thermal stimulation product group, of which 1,308 devices were licensed by February 4, 2022, and 53.2% of them (n=696) were devices with valid permits for distribution in Korea. Among the licensed devices, heating pad systems under/overlay (electric, home use) were approved the most, but combinational stimulator (for medical use, home use; Grade 2) accounted for the highest percentage among the current valid permission. Moxibustion apparatuses were licensed separately for electrical use and non-electrical use, and occupied a low percentage of the total devices. We analyzed 307 devices that were accompanied by technical documents and found that the heat sources were wires in 145 (47.2%), infrared rays in 44 (14.3%) and ultrasonic waves in 42 (13.7%) devices. Most (83.1%) devices were used for pain relief, while other applications included beauty, cancer treatment, maintenance of infant body temperature, and healing fractures. Conclusions : Thermal stimulation devices accounted for about 0.9% of all medical devices, and among them, combinational stimulators and heating pad systems under/overlay had the most valid permits. Thermal stimulation devices using heating wires and infrared rays were the most prevalent, and most were used to relieve pain. In order to develop a range of thermal stimulation devices that can be utilized in Korean medical institutions, it is imperative that they have potential applications beyond pain management, addressing various medical purposes. To achieve this, foundational research is necessary to effectively apply diverse heat sources based on medical objectives.

• Korean Journal of Acupuncture
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• v.31 no.1
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• pp.1-4
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• 2014

Objectives : The capillary destruction has frequently been used to treat telangiectasia in Korean Medicine. The objective of this study was to review of related literature concerning the capillary destruction as treatment for telangiectasia, and to discuss the clinical application of medical devices in accordance with the principles of Korean Medicine. Methods and Results : An extensive traditional literature including Huangdi Neijing were reviewed for identification of relevant evidence for treating telangiectasia. The telangiectasia is simply defined as a dilated, superficial blood vessel. It is called as the tertiary collateral vessel, superficial collateral vessel or Hyulrak(small superficial collateral vessel). The telangiectasia could be due to disturbances in the circulation of qi and blood. According to Huangdi Neijing, one of the oldest traditional literature published in 4th century B.C. through the first century A.D., it is needed to get rid of the vessel by the capillary destruction for treating telangiectasia using lance needle, shear needle, stiletto needle or moxibustion. Several studies have examined that intense pulsed light or laser as new therapeutic tools could have an sufficiently impact on aspects of improving the effectiveness of the capillary destruction. Conclusions : The capillary destruction for the treatment of telangiectasia has been used since two thousand years ago. We suggested that medical devices, such as intense pulsed light or laser, should be used to treat telangiectasia as a safe and convenient intervention in clinical practice of Korean Medicine.