• Journal of Acupuncture Research
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• v.30 no.3
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• pp.135-140
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• 2013

Objectives : The purpose of this study is to investigate the repeatability and reproducibility of the Ryodoraku acupuncture device. For such device to be accepted as a good apparatus for clinical diagnosis, the score it provides should be stable no matter who measure it or when it is measured, assuming all other conditions equal. Materials and Methods : Three oriental medical doctors who were well trained and fully aware of the usage of the Ryodoraku acupuncture device examined ten randomly selected patients three times. Each doctor measured the Ryodoraku scores three times from each of the 10 selected patients. Three doctors were involved in this experiment to investigate the reproducibility and each of them measured the Ryodoraku scores three times from each patient to investigate the repeatability. Data was analyzed with Friedman test, Spearman correlation test, and intra-class correlation coefficient(ICC) in SPSS ver. 18. Results : 1. The Friedman test showed that there is no statistically significant difference between the 1st, 2nd and 3rd Ryodoraku scores measured by the same examiner. It indicates that the Ryodoraku acupuncture device provides the repeatability. 2. Spearman correlation test confirmed the results obtained by the Fiedman test by showing that there exists a strong positive correlation between the three Ryodoraku scores measured by the same examiner. 3. A very high ICC among the three examiner assured that the Ryodoraku acupuncture device achieves the reproducibility. Conclusions : The Ryodoraku acupuncture device achieves the repeatability and reproducibility. However, we still recommend that a doctor trained to a certain level use the Device to carry out the diagnosis. Also, to improve the device in terms of Reproducibility even more, it should be considered to provide a manual for the exact usage.

• Journal of Biomedical Engineering Research
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• v.30 no.1
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• pp.23-33
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• 2009

It can be used easily to reduce rehabilitation and treatment time if diagnostic and therapeutic devices are attached to cloth or body. Therefore we developed neuromuscular wearable ultra-miniature lighting modules which can improve the neuromuscular function and verified its clinical effectiveness. The system is based on the ultra-miniature lighting treatment module and there are two types of systems. One of them is designed as an attached type and the other type is combined with clothing. The wearable ultra-miniature lighting module is composed of controller (battery, MCU, bidirectional transmitter and receiver), cable, treatment medium generating device and other peripheral devices. To verify the clinical effectiveness of this device, we observed the difference of the strength of a muscle before and after 650nm and 25mW laser irradiation on the reflex point for 1 to 4 seconds. Among 48 patients having the degenerative osteoarthritis, the muscle strength before and after irradiation of laser was $21.8{\pm}7.99$ and $27.3{\pm}8.43$. According to the result, the muscle strength after treatment was significantly increased (p<0.01). To whom having difficulty in visiting to OPD(Out-Patient Department), doctors medically examine the patients and find the therapeutic point, attachment of this wearable ultra-miniature lighting module can function as self treatment (treating instrument) and treatment assist at home. If doctor can remotely control the patient and take part in treatment, the therapeutic device could contribute to prevention and care device.

• Journal of Acupuncture Research
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• v.28 no.2
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• pp.49-55
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• 2011

Objectives : This study was to develop programmable and rechargeable electronic moxibustion device as an interdisciplinary research focusing on traditional Korean medicine. Methods : This device deployed several advances on safety and conveniences with the advantage of programmable heat stimulation, heating material and recharging method. The gradient of heat stimulation was programmed with the reference of previous studies and own measurements. The heat curve reached its efficacious stimulus temperature after three minutes, and maintained until 13 minutes with $42^{\circ}C$. We also incorporated feedback from field hospital experiences with the help of hospital staffs. Results : This device can prevent damages from skin burn and fire accidents, and control the smoke, smell and residue of moxa itself. Conclusions : This study will contribute for the development and improvement of efficacious and safe treatment methods for the traditional Korean medicine.

• The Journal of Korean Physical Therapy
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• v.23 no.5
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• pp.29-34
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• 2011

Purpose: The purpose of this study is to evaluate the short term effects of the traction and decompression device, which is a newly developed domestic medical device, on pain and functional activity in patients with chronic low back pain with or without radicular pain. Methods: Forty patients with chronic low back pain were included and allocated to decompression (n=20) and traction groups (n=20). They received decompression or traction therapy for 20 minutes a day, 3 days per week for two weeks. For evaluating pain and functional activity, a visual analogue scale (VAS) for low back pain and the Oswestry back pain disability index (ODI) were obtained on pre-treatment, and at 6, 12 and 15 days after treatment. Patients'satisfaction levels were measured 15 days after treatment. Results: VAS was significantly decreased at 12 days and 15 days post-treatment compared to pre-treatment in both groups (p<0.05). ODI was significantly decreased at 12 days and 15 days post-treatment compared to pre-treatment in the decompression group (p<0.05). However, there was no significant difference between the two groups in the VAS and ODI scales (p>0.05). Patients' satisfaction levels were significantly higher in the decompression group than in the traction group (p<0.05). Conclusion: These findings suggest that decompression therapy might be effective for increasing functional activity in patients with low back pain and could provide patients with higher satisfaction than traction therapy. This study provided validity data for the therapeutic effects of the decompression device in patients with low back pain and it will be useful for medical cost development and patient education of this device.

• Journal of Veterinary Clinics
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• v.39 no.4
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• pp.177-184
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• 2022

Caval syndrome is a severe complication of canine heartworm disease in which affected dogs present with various clinical signs that are often life-threatening. In cases of severe infection, adulticidal treatment has numerous complications as a result of a marked immune response against dead worms. Therefore, several surgical and non-surgical methods, including interventional extraction, have been applied in veterinary medicine. Despite the usefulness and efficiency of conventional retrieval devices, a few associated limitations must be addressed to reduce their risks and increase their applicability. Herein, we introduced a case of treating three dogs with caval syndrome by applying a newly developed heartworm basket device. The dogs were diagnosed with heartworm disease by heartworm antigen testing and direct smear. Imaging findings revealed remarkable remodeling of the right heart and pulmonary vessels and the presence of heartworms in the right heart. Additionally, heartworms were confirmed in the distal part of the abdominal aorta and femoral arteries in one dog, indicating aberrant systemic migration of the worms. Under general anesthesia, the heartworm basket device was introduced into the right heart via femoral venotomy and arteriotomy in one dog and jugular venotomy in the other two dogs. Although the number of cases in this study was small, the basket device was successful in gradual and cautious extraction of the heartworms in all three dogs. They exhibited good prognosis of clinical symptoms as indicated by imaging analyses.

• Korean Journal of Clinical Pharmacy
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• v.33 no.4
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• pp.221-241
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• 2023

Background: The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. Methods: Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. Results: Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. Conclusion: The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.

• Communications for Statistical Applications and Methods
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• v.24 no.6
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• Journal of Biomedical Engineering Research
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• v.41 no.1
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• pp.35-41
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• 2020

In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome^®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

• Journal of the Korean Arthroscopy Society
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• v.9 no.2
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• pp.180-185
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• 2005

Purpose: To purpose of this study is to evaluate the clinical and radiological results of arthroscopic meniscus repair using Rapid Loc device. Materials and Methods: A retrospective study was performed on 44 cases which had been turned out longitudinal tear without degeneration. We repaired all cases with Rapid Loc device. Patients were evaluated using clinical examination, Orthopaedische Arbeitsgemeinschaft Knie (OAK) scheme, and MRI. We regarded patients with joint line tenderness, swelling or McMurray positive test as clinical failure. Results: A mean age was 33.3 years and follow-up period was average 15 months. Clinical results were excellent 15 cases(34.1%), good 20 cases(45.5%), fair 7 cases(15.9%), poor 2 cases(4.5%). MRI showed grade 115 cases(33.3%), grade II 22 cases(50%), grade III 7 cases(16.7%). Clinical failures were 8 cases and only one complication was developed. Conclusion: Rapid Loc device showed the excellent results in meniscus repair. We regard it has a lot of advantages in safety, softness, ease, ability to control tension at repair site.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.6
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• pp.662-667
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• 2014

The purpose of this clinical study is to develop structured clinical trial protocol and guideline for improvement of safety, useful and effective of pulse diagnosis devices. As a first step, papers on pulse diagnosis and pulse diagnosis devices from 2001 and 2013 were systematically reviewed. In the next step, we have collected the opinions from the specialists, companies, and statistician in pulse diagnosis to evaluate the current condition, the state and problem of domestic clinical trial cases of pulse diagnosis device. And we have to created protocol and case report form (CRF) in regards to site condition and characteristics of pulse diagnosis devices, and showed the guideline of eligibility criteria, operation process, investigation items, evaluation items and so on. This clinical protocol will become a basic information for a researcher in designing or performing a clinical study of pulse diagnosis devices, and be used as a useful material during acquisition of good clinical data. Furthermore, we hope to enhance the invigoration of pulse diagnosis clinical trials and the performance improvement of pulse diagnosis devices.