• Journal of Acupuncture Research
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• v.26 no.5
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• pp.105-116
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• 2009

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

• Journal of Acupuncture Research
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• v.32 no.2
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• pp.11-21
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• 2015

Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

• Journal of Acupuncture Research
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• v.23 no.6
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• pp.1-8
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• 2006

Introduction : Even though Acupuncture has been know for its effect for a long time, recently it is required to verifiy its effect. To solve this, clinical trial, based on EBM, has been the way to explain acupuncture's treatment effect. Methods: Last year we had a clinical trial based on acupuncture. From this experience we came to a conclusion mentioned below. Results : 1. To find out acupuncture's effect more certainly, it is needed that Korean medical method or treatment should be connected to diagnosis. 2. We had found out that sham and minimal acupuncture are the most appropriate way in single blinding. 3. It is required for the acupuncturist to practice the right real acupuncture point and sham's point in clinical trial. 4. The most important thing to maintain the subjects from dropping out is to always be concerned to the subjects and management them. Conclusion : The best way to advance clinical trial on acupuncture is to use single blinding system with sham acupuncture together in controlled groups and most of all also needs a standardized acupuncture point and depth.

• Journal of Physiology & Pathology in Korean Medicine
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• v.32 no.4
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• pp.271-276
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• 2018

The purpose of pilot clinical trial is to evaluate the efficacy and safety of acupuncture therapy on TEWL(Transepidermal Water Loss) and skin hydration. A total of 36 human who visited Dongshin University Oriental Medical Center from October 2nd, 2015 to July 31st, 2016 were included in the pilot clinical trial. Acupuncture therapy was performed at Gokji(LI11) and Daechu(GV14). We observed change of TEWL(Transepidermal Water Loss), skin hydration before and after acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically significant decline($8.01{\pm}2.55{\rightarrow}6.58{\pm}1.97g/h/m2$, $7.40{\pm}2.65{\rightarrow}4.99{\pm}1.89g/h/m2$). Index of skin hydration showed statistical significance($52.83{\pm}6.53{\rightarrow}56.82{\pm}7.24$, $63.50{\pm}8.57{\rightarrow}64.96{\pm}8.48$). To evaluate the safety, vital sign check were conducted and showed no statistically significant result. And there were no severe adverse events during this study. According to the above pilot clinical trial, it is suggested acupuncture therapy were effective for skin moisturizing.

• Journal of Acupuncture Research
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• v.36 no.2
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• pp.100-106
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• 2019

Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.

• Korean Journal of Acupuncture
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• v.29 no.4
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• pp.581-597
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• 2012

Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

• Journal of Physiology & Pathology in Korean Medicine
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• v.32 no.4
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• pp.291-297
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• 2018

The purpose of pilot clinical trial is to evaluate the efiicacy and safety of Needle-Embedding acupuncture therapy on TEWL(Transepidermal Water Loss) and Skin hydration. A total of 24 human who visited Dongshin Oriental Medical Center from December 1st, 2016 to July 31st, 2017 were included in the pilot clinical trial. Needle-Embedding acupuncture therapy performed at Gokji(LI11). We observed change of TEWL(Transepidermal Water Loss), Skin hydration before and after Needle-Embedding acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically insignificant decline ($8.5{\pm}2.12{\rightarrow}7.8{\pm}1.53g/h/m^2$). Index of skin hydration showed a statistically significant result ($38.2{\pm}6.77{\rightarrow}36.8{\pm}6.64$). To evaluate the safety, Adverse events and Vital sign check were conducted and there were no problem. And when the physical response, self-awareness, skin system, musculoskeletal pain, and other abnormal responses were assessed 60 minutes and 24 hours and 7 days after Needle-Embedding acupuncture therapy at Gokji(LI11) for stability assessment, Adverse events disappeared during a pilot clinical trial. According to the above pilot clinical trial, it is suggested Needle-Embedding acupuncture therapy were effective for Skin moisturizing and safe.

• Journal of Acupuncture Research
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• v.30 no.3
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• pp.109-115
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• 2013

Objectives : This study was aimed to find the motivation and satisfaction of subjects who participated in acupuncture and moxibustion clinical trials and to suggest ways to improve clinical trial management. Methods : We conducted a survey and collected the data of 233 subjects of acupuncture and moxibustion clinical trials from 6 university hospitals. Results : For all 233 subjects, the mean of the total satisfaction score was 4.07 (perfect score 5.0), and the score was particularly high in aspects of the investigator and clinical research coordinator, but low in the site and sponsor aspects. There were no differences in the satisfaction degree with general characteristics. The satisfaction degree of the acupuncture and moxibustion clinical trials was strong positive correlated with participation benefits(r=0.595) and easy contact with the research team (r=0.500). Conclusions : Most subjects showed positive perception and interest in the clinical trials. Future studies should investigate how personal factors influence the satisfaction of subjects, should identify a specific classification criterion, and create a standardized protocol for the clinical trials.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.30 no.3
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• pp.76-87
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• 2017

Objectives : This study aimed to analyze the recent acupuncture clinical trial on atopic dermatitis and to suggest the plan about how to improve its quality. Methods : Data were collected through electronic database including MEDLINE. We set up the search terms for "atopic dermatitis AND acupuncture" and limited period of data within 6 years and type for RCT(Randomized Clinical Trial), SR(Systemic Review). Results : Total 5 studies were selected. Two were RCTs, and the rest were SRs. RCTs were insufficient about acupoint selection criteria and foundation. SRs both pointed out that systematic clinical trial is required. Conclusions : Based on these, we suggested the plan as follows. 1. Selection criteria - We should reevalute the participants by using diagnostic criteria and scales. 2. Selection acupoints - We should present the foundation that why we choose these acupoints. 3. Establishing acupuncture and control group - We should make control group clearly after calculating the number of participants statistically. 4. Blinding - We should propse the method, type, procedure and evaluation about randomization. 5. Evaluation scale - We should select the suitable scales for research objectives.

• Korean Journal of Acupuncture
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• v.26 no.4
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• pp.53-66
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• 2009

Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.