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Background: Clinicians often apply heating or cooling stimulation for treatment of musculoskeletal pain. However, scalding, frostbite and skin ulcers may occur from the excessive use of either therapy alone. Heating and cooling combination therapy may be a suitable alternative for treatment of musculoskeletal diseases, although insufficient research has documented the safety and efficacy of such therapy. The purpose of this clinical trial is to determine the efficacy and safety of heating and cooling combination therapy for treatment of chronic low back pain.Methods/design: This is a multicenter, parallel-group, double-blinded, randomized controlled trial to evaluate the efficacy and safety of a heating and cooling combination therapeutic device (OCH-S100) in patients with chronic low back pain. Eighty participants with chronic low back pain will be recruited from two hospitals in South Korea (Dongguk University Ilsan Oriental Hospital and Dongguk University Bundang Oriental Hospital). Enrolled patients will be randomly divided into a treatment group and a sham group. Patients in both groups will be given 10 treatments (15 min per treatment) over 4 weeks. The protocol will consist of five cycles of heating/cooling therapy (maximum: 45 °C, minimum: 15 °C) in the treatment group, and five cycles of sham therapy (maximum: 1 °C above skin temperature, minimum: 1 °C below skin temperature) in the sham group. The primary outcome measure is change from baseline in the 100 mm Visual Analogue Scale (VAS) for pain after 4 weeks. There are six secondary outcome measures that consider disability or range of motion (ROM).Discussion: This research will determine the efficacy and safety of heating and cooling combination therapy on chronic low back pain. The results of this trial may have important implications for the more widespread use of heating and cooling combination therapy for treatment of musculoskeletal pain.Trial Registration: NCT02289170 (14 October 2014). [ABSTRACT FROM AUTHOR]

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN.Methods/design: This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient's global impression of change and adverse events. Safety will be assessed at each visit.Discussion: The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA.Trial Registration: Clinical Research Information Service: KCT0000506. [ABSTRACT FROM AUTHOR]

Background: Acupuncture is an effective yet complex therapy, integrating syndrome differentiation, selection of appropriate acupoints and skillful needling techniques. Clinicians carefully tailor acupuncture treatment to each patient. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individualdifferences and, as a result, have not been reflective of the true efficacy of clinical practice. To determine the efficacy of meridian-based syndrome differentiation and Sa-am acupuncture, we have designed a simple pragmatic trial providing individualized treatments while working within a general framework.Methods/design: The study is designed to be a parallel, patient- and assessor-blind, randomized controlled trial (RCT). A total of250 patients with knee osteoarthritis (OA) will be recruited from two independent hospitals, Semyung University Oriental Medicine Hospital in Chung-ju and Dongguk University Oriental Hospital in Ilsan, South Korea. Patients will be randomly allocated into four treatment groups: 1. individualized, meridian-based syndrome differentiation and Sa-am acupuncture treatment;2. standard acupuncture treatment;3. sham acupuncture treatment; and 4. no acupuncture treatment. Patients in groups 1 to 3 will be treated by certified oriental medicine doctors twice a week for 6 weeks. The primary outcome measure will be the self-reported total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change. The trial will also include secondary outcome measures.Discussion: This trial is designed to determine the efficacy of individualized acupuncture treatment in patients with knee OA by comparing the differences between individualized, standard, sham and no acupuncture treatments. The results of this trial may validate the efficacy of individualized acupuncture therapy, encouraging its widespread use.Trial Registration: ClinicalTrials.gov: NCT01569230. [ABSTRACT FROM AUTHOR]

Background: Cancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life. However, there is currently no confirmed standard treatment for cancer-related fatigue, and thus, many patients who suffer cancer-related fatigue seek complementary and alternative medicines such as moxibustion. Moxibustion is one of the most popular therapies in traditional Korean medicine used to manage fatigue. Recent studies have also demonstrated that moxibustion is effective for treating chronic fatigue. However, there is insufficient evidence supporting the effect of moxibustion against cancer-related fatigue. The aim of this study is to assess the efficacy and safety of moxibustion treatment for cancer-related fatigue., Methods/design: A multi-center, three-armed parallel, randomized controlled trial will be conducted. Ninety-six patients with cancer-related fatigue will be recruited from three clinical research centers. They will be randomly allocated to one of three groups in a 1:1:1 ratio. The moxibustion group will receive moxibustion treatment at CV8, CV12, LI4 and ST36. The sham moxibustion group will receive sham moxibustion at non-acupoints. Both the moxibustion and sham moxibustion groups will receive 30-min treatments twice a week for 8 weeks. The usual care group will not receive moxibustion treatment. All participants will be educated via a brochure on how to manage cancer-related fatigue in daily life. The outcome measurements will be evaluated at baseline, week 5, week 9, and week 13 by assessors who are blinded to the group allocation. The primary outcome measure will be the mean change in the average scores of the Brief Fatigue Inventory before and after treatments between groups. The secondary outcome measures will be the mean difference in changes from baseline of the Brief Fatigue Inventory, functional assessments of cancer therapy-fatigue, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 scores, and Montreal Cognitive Assessment scores between groups. Safety will be assessed by monitoring adverse events at each visit., Discussion: The results of this study will provide evidence to confirm whether moxibustion can be used as a therapeutic option for treating cancer-related fatigue., Trial Registration: Clinical Research Information Service KCT0002170 . Registered 16 December 2016.

Background: Differences between the characteristics of culture positive pyogenic spondylitis (CPPS) and tuberculous spondylitis (TS) are well known. However, differences between the characteristics of culture negative pyogenic spondylitis (CNPS) and TS have not been reported; these would be more helpful in clinical practice especially when initial microbiologic examination of blood and/or biopsy tissue did not reveal the causative bacteria in patients with infectious spondylitis., Methods: We performed a retrospective review of the medical records of patients with CNPS and TS. We compared the characteristics of 71 patients with CNPS with those of 94 patients with TS., Results: Patients with TS had more previous histories of tuberculosis (9.9 vs 22.3 %, p = 0.034), simultaneous tuberculosis other than of the spine (0 vs 47.9 %, p < 0.001), and positive results in the interferon-gamma release assay (27.6 vs 79.2 %, p < 0.001). Fever (15.5 vs. 31.8 %, p = 0.018), psoas abscesses (15.5 vs 33.0 %, p = 0.011), and paravertebral abscesses (49.3 vs. 74.5 %, p = 0.011) were also more prevalent in TS than CNPS., Conclusions: Different from or contrary to the previous comparisons between CPPS and TS, fever, psoas abscesses, and paravertebral abscesses are more common in patients with TS than in those with CNPS.

Background: The issue of collaboration in medical education is becoming prominent. Some faculty development programs have suggested an approach for promoting collaboration on a global level. However, non-English-speaking developing countries in Asia, especially in Southeast Asia, do not take advantage of them due to their unique context, such as language and culture. To address these issues, Seoul National University College of Medicine initiated a 6-week international faculty development program called the "Seoul Intensive Course for Medical Educators" for 16 fellows from five Asian countries (Cambodia, Laos, Mongolia, Myanmar, and Vietnam). The aim of this study is to report the evaluation results of the outcome of the program and discuss better ways of collaborating with developing countries., Methods: Three levels of collaboration-intraorganizational, intranational, and international-were central initiatives of the program. Prior to setting up the program details, we first established four design principles, following which the contents, materials, and facilitators were determined to maintain consistency with the design principles. The evaluation of the program was done with Kirkpatrick's four-level model. Most of the evaluation data for level 1 were collected by two questionnaires, the post-module survey and the post-program survey. Portfolios and progress reports were mainly used to collect outcome data for levels 2 and 3, respectively., Results: The reaction was generally positive throughout the program and there was a significant correlation between satisfaction and relevance to one's job or needs. Despite the fellows' propensity for overestimating themselves, both the evaluators and fellows reported that there was significant improvement in learning. Opinions on the impact or urgency of the topics were slightly different from country to country; however, the answers regarding feasibility were fairly similar. Moreover, we could observe from the post-program progress reports that the transfer of learning was actively in progress, mainly for topics that were highly feasible., Conclusions: These results show that the program was successful in terms of its effectiveness. Consistent and timely support is essential for the sustainable development of the medical education systems in these countries. Further understanding of the underlying factors on transfer (level 3) could improve the effectiveness of faculty development programs for developing countries.

Background: Clinicians often apply heating or cooling stimulation for treatment of musculoskeletal pain. However, scalding, frostbite and skin ulcers may occur from the excessive use of either therapy alone. Heating and cooling combination therapy may be a suitable alternative for treatment of musculoskeletal diseases, although insufficient research has documented the safety and efficacy of such therapy. The purpose of this clinical trial is to determine the efficacy and safety of heating and cooling combination therapy for treatment of chronic low back pain., Methods/design: This is a multicenter, parallel-group, double-blinded, randomized controlled trial to evaluate the efficacy and safety of a heating and cooling combination therapeutic device (OCH-S100) in patients with chronic low back pain. Eighty participants with chronic low back pain will be recruited from two hospitals in South Korea (Dongguk University Ilsan Oriental Hospital and Dongguk University Bundang Oriental Hospital). Enrolled patients will be randomly divided into a treatment group and a sham group. Patients in both groups will be given 10 treatments (15 min per treatment) over 4 weeks. The protocol will consist of five cycles of heating/cooling therapy (maximum: 45 °C, minimum: 15 °C) in the treatment group, and five cycles of sham therapy (maximum: 1 °C above skin temperature, minimum: 1 °C below skin temperature) in the sham group. The primary outcome measure is change from baseline in the 100 mm Visual Analogue Scale (VAS) for pain after 4 weeks. There are six secondary outcome measures that consider disability or range of motion (ROM)., Discussion: This research will determine the efficacy and safety of heating and cooling combination therapy on chronic low back pain. The results of this trial may have important implications for the more widespread use of heating and cooling combination therapy for treatment of musculoskeletal pain., Trial Registration: NCT02289170 (14 October 2014).

Background: Contrast medium used for radiologic tests can decrease renal function. However there have been few studies on contrast-associated acute kidney injury in intensive care unit (ICU) patients. The objective of this study was to evaluate the incidence, characteristics, and outcome of contrast-associated acute kidney injury (CA-AKI) patients using the Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria in critically ill patients in the ICU., Methods: We conducted a retrospective study of adult patients who underwent contrast-enhanced radiologic tests from January 2011 to December 2012 in a 30-bed medical ICU and a 24-bed surgical ICU., Results: The study included 335 patients, and the incidence of CA-AKI was 15.5%. The serum creatinine and estimated glomerular filtration rate values in the CA-AKI patients did not recover even at discharge from the hospital compared with the values prior to the contrast use. Among 52 CA-AKI patients, 55.8% (n = 29) had pre-existing kidney injury and 44.2% (n = 23) did not. The CA-AKI patients were divided into risk (31%), injury (31%), and failure (38%) by the RIFLE classification. The percentage of patients in whom AKI progressed to a more severe form (failure, loss, end-stage kidney disease) increased from 38% to 45% during the hospital stay, and the recovery rate of AKI was 17% at the time of hospital discharge. Because the Acute Physiology and Chronic Health Evaluation (APACHE) II score was the only significant variable inducing CA-AKI, higher APACHE II scores were associated with a higher risk of CA-AKI. The ICU and hospital mortality of patients with CA-AKI was significantly higher than in patients without CA-AKI., Conclusions: CA-AKI is associated with increases in hospital mortality, and can be predicted by the APACHE score., Trial Registration: NCT01807195 on March. 06. 2013.

Background: This study was conducted to investigate awareness of clinical trials (CTs) including perceptions of favorable feelings about, necessity for, and safety of CTs, the ultimate beneficiary of CTs and the factors associated with willingness to participate in CTs among the general population in South Korea., Methods: A cross sectional survey study was conducted in a randomly selected national sample of 1,515 Korean., Results: Perception toward CTs was measured using a scale from 0 (strongly disagree) to 10 (strongly agree). Respondents readily understood the necessity for CTs (M = 7.27, SD = 2.15); had moderately favorable feelings (M = 5.32, SD = 2.31) toward CTs and felt that these CTs were moderately safe (M =  .71, SD = 1.90). Twenty-five percent of the respondents answered that they would be willing to participate in a CT in the future. Perception of the ultimate benefits of CTs, awareness, favorable feelings, safety, and necessity regarding CTs were identified as significant predictors of willingness to participate in CTs., Conclusion: An awareness of CTs and the perceptions toward CTs were associated with general public willingness to participate in a CT. Findings from this study can be used in planning outreach and recruitment strategies, and to understand the predictors of CT participation.

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN., Methods/design: This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient's global impression of change and adverse events. Safety will be assessed at each visit., Discussion: The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA., Trial Registration: Clinical Research Information Service: KCT0000506.

Prolonged high-fat diet leads to the development of obesity and multiple comorbidities including non-alcoholic steatohepatitis (NASH), but the underlying molecular basis is not fully understood. We combine molecular networks and time course gene expression profiles to reveal the dynamic changes in molecular networks underlying diet-induced obesity and NASH. We also identify hub genes associated with the development of NASH. Core diet-induced obesity networks were constructed using Ingenuity pathway analysis (IPA) based on 332 high-fat diet responsive genes identified in liver by time course microarray analysis (8 time points over 24 weeks) of high-fat diet-fed mice compared to normal diet-fed mice. IPA identified five core diet-induced obesity networks with time-dependent gene expression changes in liver. These networks were associated with cell-to-cell signaling and interaction (Network 1), lipid metabolism (Network 2), hepatic system disease (Network 3 and 5), and inflammatory response (Network 4). When we merged these core diet-induced obesity networks, Tlr2, Cd14, and Ccnd1 emerged as hub genes associated with both liver steatosis and inflammation and were altered in a time-dependent manner. Further, protein-protein interaction network analysis revealed Tlr2, Cd14, and Ccnd1 were interrelated through the ErbB/insulin signaling pathway. Dynamic changes occur in molecular networks underlying diet-induced obesity. Tlr2, Cd14, and Ccnd1 appear to be hub genes integrating molecular interactions associated with the development of NASH. Therapeutics targeting hub genes and core diet-induced obesity networks may help ameliorate diet-induced obesity and NASH.

Background: Musculoskeletal diseases are becoming increasingly important due to population aging. However, studies on the economic burden of musculoskeletal disease in Korea are scarce. Therefore, we conducted a population-based study to measure the economic burden of musculoskeletal disease in Korea using nationally representative data., Methods: This study used a variety of data sources such as national health insurance statistics, the Korea Health Panel study and cause of death reports generated by the Korea National Statistical Office to estimate the economic burden of musculoskeletal disease. The total cost of musculoskeletal disease was estimated as the sum of direct medical care costs, direct non-medical care costs, and indirect costs. Direct medical care costs are composed of the costs paid by the insurer and patients, over the counter drugs costs, and other costs such as medical equipment costs. Direct non-medical costs are composed of transportation and caregiver costs. Indirect costs are the sum of the costs associated with premature death and the costs due to productivity loss. Age, sex, and disease specific costs were estimated., Results: Among the musculoskeletal diseases, the highest costs are associated with other dorsopathies, followed by disc disorder and arthrosis. The direct medical and direct non-medical costs of all musculoskeletal diseases were $4.18 billion and $338 million in 2008, respectively. Among the indirect costs, those due to productivity loss were $2.28 billion and costs due to premature death were $79 million. The proportions of the total costs incurred by male and female patients were 33.8% and 66.2%, respectively, and the cost due to the female adult aged 20-64 years old was highest. The total economic cost of musculoskeletal disease was $6.89 billion, which represents 0.7% of the Korean gross domestic product., Conclusions: The economic burden of musculoskeletal disease in Korea is substantial. As the Korean population continues to age, the economic burden of musculoskeletal disease will continue to increase. Policy measures aimed at controlling the cost of musculoskeletal disease are therefore required.

Background: Calculating the Charlson comorbidity index (CCI) from medical records is a time-consuming and expensive process. The objectives of this study are to 1) measure agreement between medical record and claims data for CCI in lung cancer patients and 2) predict health outcomes of lung cancer patients based on CCIs from both data sources., Methods: We studied 392 patients who underwent surgery for pathologic stages I-III of lung cancer. The kappa value was used to measure the agreement between the 17 comorbidities of the CCI prevalence obtained from medical records and claims data. Multiple linear regression analyses were used to evaluate the relationships between CCI and length of stay and reimbursement cost., Results: Out of 17 comorbidities identified in the Charlson comorbidity index, ten had a higher prevalence, four had a lower prevalence and three had a similar prevalence in claims data to those of medical records. The kappa values calculated from the two databases ranged from 0.093 to 0.473 for nine comorbidities. In predicting length of stay and reimbursement cost after surgical resection for lung cancer patients, the CCI scores derived from both the medical records and claims data were not statistically significant., Conclusions: Poor agreement between medical record data and claims data may result from different motivations for collecting data. Further studies are needed to determine an appropriate method for predicting health outcomes based on these data sources.

Background: S100 calcium binding protein A8 (S100A8) has been implicated as a prognostic indicator in several types of cancer. However, previous studies are limited in their ability to predict the clinical behavior of the cancer. Here, we sought to identify a molecular signature based on S100A8 expression and to assess its usefulness as a prognostic indicator of disease progression in non-muscle invasive bladder cancer (NMIBC)., Methods: We used 103 primary NMIBC specimens for microarray gene expression profiling. The median follow-up period for all patients was 57.6 months (range: 3.2 to 137.0 months). Various statistical methods, including the leave-one-out cross validation method, were applied to identify a gene expression signature able to predict the likelihood of progression. The prognostic value of the gene expression signature was validated in an independent cohort (n = 302)., Results: Kaplan-Meier estimates revealed significant differences in disease progression associated with the expression signature of S100A8-correlated genes (log-rank test, P < 0.001). Multivariate Cox regression analysis revealed that the expression signature of S100A8-correlated genes was a strong predictor of disease progression (hazard ratio = 15.225, 95% confidence interval = 1.746 to 133.52, P = 0.014). We validated our results in an independent cohort and confirmed that this signature produced consistent prediction patterns. Finally, gene network analyses of the signature revealed that S100A8, IL1B, and S100A9 could be important mediators of the progression of NMIBC., Conclusions: The prognostic molecular signature defined by S100A8-correlated genes represents a promising diagnostic tool for the identification of NMIBC patients that have a high risk of progression to muscle invasive bladder cancer.

Background: While several molecular markers of bladder cancer prognosis have been identified, the limited value of current prognostic markers has created the need for new molecular indicators of bladder cancer outcomes. The aim of this study was to identify genetic signatures associated with disease prognosis in bladder cancer., Results: We used 272 primary bladder cancer specimens for microarray analysis and real-time reverse transcriptase polymerase chain reaction (RT-PCR) analysis. Microarray gene expression analysis of randomly selected 165 primary bladder cancer specimens as an original cohort was carried out. Risk scores were applied to stratify prognosis-related gene classifiers. Prognosis-related gene classifiers were individually analyzed with tumor invasiveness (non-muscle invasive bladder cancer [NMIBC] and muscle invasive bladder cancer [MIBC]) and prognosis. We validated selected gene classifiers using RT-PCR in the original (165) and independent (107) cohorts. Ninety-seven genes related to disease progression among NMIBC patients were identified by microarray data analysis. Eight genes, a progression-related gene classifier in NMIBC, were selected for RT-PCR. The progression-related gene classifier in patients with NMIBC was closely correlated with progression in both original and independent cohorts. Furthermore, no patient with NMIBC in the good-prognosis signature group experienced cancer progression., Conclusions: We identified progression-related gene classifier that has strong predictive value for determining disease outcome in NMIBC. This gene classifier could assist in selecting NMIBC patients who might benefit from more aggressive therapeutic intervention or surveillance.