Multicentre randomised controlled clinical trial of electroacupuncture with usual care for patients with non-acute pain after back surgery.

BACKGROUND: The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery. METHODS: In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5. RESULTS: Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment. CONCLUSIONS: The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery. CLINICAL TRIAL REGISTRATION: KCT0001939.

Characteristics and status of Korean medicine use in whiplash-associated disorder patients.

BACKGROUND: Patients are free to choose conventional or Korean medicine treatment under the dual medical system in Korea, and the prevalence of patients who choose Korean medicine treatment for whiplash-associated disorders (WADs) is high. This study analyzed the sociodemographic characteristics and medical service use in this population to provide healthcare providers with basic usage information of complementary and alternative medicine for WAD. METHODS: A total of 8291 outpatients who registered under automobile insurance coverage and visited the main branch of Jaseng Hospital of Korean Medicine from April 1, 2014 to August 10, 2016 were included. Data on sociodemographic characteristics, symptoms, and accident and treatment-related details were collected from electronic medical records. Univariate and multivariate regression analyses were performed to identify baseline factors predictive of total treatment duration. RESULTS: The most prevalent demographic of patients who chose Korean medicine for WAD treatment was males in their thirties whose initial visit to the hospital was 16.1 ± 94.1 days from the accident. Neck pain accompanied by low back pain (57.0%) was the most common complaint, and for singular pain, neck pain (13.5%) was the most prevalent. Baseline numeric rating scale (NRS) pain levels were generally moderate (4-6) regardless of area. Patients received 7.2 ± 10.2 sessions of treatment for 32.6 ± 55.3 days. The most commonly prescribed treatment modalities in order of highest frequency were acupuncture, cupping, pharmacopuncture, and herbal medicine, which collectively accounted for > 90% of treatments. Acupuncture was administered 29.0 ± 40.8 times, and cupping 14.0 ± 18.7 times as the two highest frequency treatments. In multivariate regression analysis, longer treatment periods were found to be associated with higher NRS, older age, and delayed initial visits at baseline. CONCLUSIONS: This study highlights the characteristics and Korean medicine use of WAD patients. These results are particularly relevant and informative for consideration of personal preferences and effective prioritization in further insurance coverage.

Analysis of medical service use of knee osteoarthritis and knee meniscal and ligament injuries in Korea: a cross-sectional study of national patient sample data.

BACKGROUND: Osteoarthritis (OA) and meniscal and ligament injuries of the knee are the two most common knee disorders in Korea. The aim of this study was to analyze the demographic characteristics, medical service use and related costs for these disorders, and the results are expected to help inform practitioners, researchers, and policy-makers. METHODS: The present study aimed to evaluate incidence and patient characteristics, and to assess current medical service use, usual care, and medical expenses of knee disorders by analyzing 2014 national patient sample data from the Korean Health Insurance Review and Assessment Service. Data was extracted using 3% stratified sampling from all Korea national health insurance claims submitted in 2014, and analyzed. Usual care for M17 knee osteoarthritis and S83 knee meniscal and ligament injury codes of the International Classification of Diseases, 10th revision (ICD-10) were determined by investigating total number of patients, sociodemographic characteristics, days in care, number of visits, and expenses. RESULTS: Knee OA showed the highest incidence in females aged ≥60 years, whereas meniscal and ligament injuries of the knee were most prevalent among patients aged <20 years and young adults. Total inpatient care expenses exceeded the cost of ambulatory care for both disorders. Ambulatory care was mainly provided at primary care clinics, with 90% of these visits made to orthopedic specialists. Medical expenses for knee OA and meniscal and ligament injuries were largely due to procedures/surgeries and injections, and procedures/surgeries and hospitalizations, respectively. Total replacement arthroplasty was the most commonly performed surgery for knee OA, while meniscectomy and cruciate ligament reconstruction were the most often performed surgeries for meniscal and ligament injuries. Intra-articular injection rates were 55% in knee OA patients and 3% in meniscal and ligament injury patients. Aceclofenac, diclofenac, and tramadol were the most frequently prescribed analgesics. CONCLUSIONS: The current findings may be used as basic data for establishing medical policies and can benefit researchers and clinicians in recognizing trends and patterns of treatment for knee disorders.

Efficacy of acupuncture for whiplash injury: a systematic review and meta-analysis.

OBJECTIVES: This study aimed to establish clinical evidence for acupuncture by analysing data from trials that demonstrated the efficacy of acupuncture for whiplash-associated disorder (WAD) with the following research question: Is acupuncture treatment effective for symptom alleviation in patients with WAD compared with other usual care? DESIGN: A systematic review and meta-analysis. DATA SOURCES: PubMed, Ovid Medline, Embase, The Cochrane Library, China National Knowledge Infrastructure, ScienceOn, KMBASE, Korean Studies Information Service System, Korea Med, Oriental Medicine Advanced Searching Integrated System and Research Information Sharing Service were searched from their inception to 1 October 2023. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) using acupuncture on patients with WAD. The outcomes were the pain visual analogue scale (VAS) score or numerical rating scale score for neck pain, the range of motion (ROM) of the neck, the Neck Disability Index and safety. DATA EXTRACTION AND SYNTHESIS: Two independent researchers analysed and extracted data from the selected literatures. The risk of bias and the quality of evidence were assessed according to the Cochrane Handbook for Systematic Reviews of Interventions and the Grading of Recommendations Assessment, Development, and Evaluation method, respectively. RESULTS: A total of 525 patients with WAD from eight RCTs were included in this study. The meta-analysis revealed that the outcomes showed significant differences in the pain VAS score (standard mean difference (SMD): -0.57 (-0.86 to -0.28), p<0.001) and ROM-extension (SMD: 0.47 (0.05 to 0.89), p=0.03). The risk of bias assessment revealed that four studies published after 2012 (50%, 4 out of 8 studies) showed low bias in most domains. The pain VAS score was graded as having moderate certainty. CONCLUSION: Acupuncture may have clinical value in pain reduction and increasing the ROM for patients with WAD. High-quality RCTs must be conducted to confirm the efficacy of acupuncture in patients with WAD. TRIAL REGISTRATION NUMBER: PROSPERO CRD42021261595.

Characteristics of Korean medical care utilization in patients with traffic injury: Analysis of 3 hospital electronic health record databases.

This retrospective study aimed to identify the characteristics of Korean medical care utilization in patients with traffic injury (TI) and to explore the clinical effectiveness of Korean medical interventions for TI through a multicenter chart review. This multicenter, retrospective registry study gathered electronic health records from 3 hospitals between January 1, 2018 and December 31, 2021. Data included treatment dates, demographic information, the Korean Standard Classification of Diseases codes, collision data, Korean medicine treatment modalities, and treatment outcomes. In total, 384 patients (182 inpatients and 202 outpatients) were included in the analysis. Patients were categorized into acute (207 patients, 53.9%), subacute (77 patients, 20.1%), and chronic (100 patients, 26.0%) phases based on the period until the visit. The most frequent Korean Standard Classification of Diseases code was "sprain and strain of cervical spine (S13.4)." All patients, except one, received Korean physiotherapy, followed by acupuncture and cupping. Comparative intragroup analysis revealed significant pain reduction in patients treated with the combination of Chuna manual therapy, herbal medicine, and pharmacopuncture and those treated with pharmacopuncture and herbal medicine only. This study highlights the characteristics of patients with TI visiting medical institutions providing Korean medicine and describes the effectiveness of Korean medicine interventions. Further comprehensive analysis with more data is necessary for future research.

Effectiveness and safety of scalp acupuncture for treating migraine: A systematic review and meta-analysis.

OBJECTIVE: Migraine is a prevalent and disabling neurological disorder affecting a significant proportion of the global population. Although medications are the primary treatment option, their efficacy remains unclear. Thus, alternative therapies such as scalp acupuncture have gained momentum; however, evidence for the effectiveness of scalp acupuncture remains insufficient. Therefore, this review provides evidence regarding the effectiveness and safety of scalp acupuncture for the treatment of migraines. DESIGN: PubMed, EMBASE, CENTRAL, Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, Korean Medical Database, NDSL, Citation Information by NII, and China National Knowledge Infrastructure were searched from their inception to September 2022 to identify randomised controlled trials (RCTs) without language restrictions. Data were collected and analysed independently by two reviewers. The RoB 2.0 tool was used to evaluate the risk of bias, and a meta-analysis was conducted using RevMan software (V5.4). SETTING: Eight RCTs including 874 patients were selected. RESULTS: Scalp acupuncture had a higher total effective rate (relative risk [RR]:1.24; 95% confidence interval [CI]:1.08-1.43; P < 0.01) than that of ordinary acupuncture. The headache index decreased significantly (standardised mean differences [SMD]:-1.27; 95% CI:-2.06 to -0.48; P < 0.01), and the total effective rate was higher (RR:1.20; 95% CI:1.06-1.37; P < 0.01) with scalp acupuncture than with medications. However, evidence supporting the effectiveness of scalp acupuncture was not robust. No adverse events were reported. CONCLUSION: Scalp acupuncture appears to be more effective than other treatments for migraines. However, their safety remains uncertain. PROSPERO REGISTRATION NUMBER: CRD42022348879.

Scalp acupuncture for stroke: A protocol for an overview of systematic reviews and meta-analysis.

BACKGROUND: Scalp acupuncture (SA) is a new acupuncture method that connects head acupoints and aculines, and many systematic reviews (SRs) have been published on its use against neuropsychiatric diseases. However, no overview of SRs on the effectiveness of SA in stroke recovery has been conducted. Therefore, our overview aims to evaluate the methodological bias and reliability of the conclusions of SRs regarding SA for stroke recovery and help clinical decision-makers translate this research into clinical policy and practice. METHODS: We will consider SRs and meta-analyses of randomized controlled trials to evaluate the effects of SA on stroke recovery. Two reviewers will identify relevant studies, extract data information, and assess the methodological quality using the Assessment of Multiple Systematic Reviews-2 tool. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses report checklist will also be included in the study to assess the quality of the reports. We will use evaluations of the Grading of Recommendations Assessment, Development and Evaluation of the authors of the included SRs. The Risk of Bias in Systematic Review tool will be used to assess the risk of bias of SRs. The screening of SRs, eligibility evaluation, data extraction, methodological quality, and quality of evidence will be conducted by independent reviewers in pairs. The outcomes of interest include the Modified Edinburgh-Scandinavian Stroke Scale, Ability of Daily Living, Functional Independence Measure, Barthel index, Fugl-Meyer assessment, clinical effective rate, and adverse events. Data will be extracted using predefined forms designed to summarize the important characteristics of each review. The evidence will be a descriptive synthesis of the type and content of the intervention and the results reported. RESULTS: The results will be published in a peer-reviewed journal. CONCLUSIONS: We expect to organize evidence from multiple SRs on the effectiveness of SA for stroke recovery and synthesize the findings in an accessible and useful documentation.

Efficacy of scalp acupuncture for migraine: A protocol for systematic review and meta-analysis.

INTRODUCTION: Migraine is a disorder that is prevalent worldwide. However, there is still no clear and effective treatment for migraine. Recently, acupuncture as a treatment has been attracting attention and studies have shown the value of scalp acupuncture. Therefore, this protocol for a systematic review and meta-analysis was created to assess the evidence of effectiveness and safety of scalp acupuncture in the treatment of migraine. METHODS: All published randomized controlled trials (RCTs) in the following databases will be searched from their inception to September 2022: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), OASIS, Korean Studies Information Service System (KISS), Korean Medical Database and NDSL, CiNii (Citation Information by NII), and the China National Knowledge Infrastructure (CNKI), without language restrictions. The data collection and analysis will be conducted independently by two reviewers. The Cochrane Collaboration tool will be used to evaluate the risk of bias by evaluating the available studies. A meta-analysis will be conducted using RevMan V.5.4 software. RESULTS: The purpose of the proposed systemic review is to systematically assess the effectiveness and safety of scalp acupuncture for the treatment of migraine. CONCLUSIONS: To sum up, this review will assess the effectiveness and safety of scalp acupuncture for the treatment of migraine. The results of this review are expected to provide new guidelines for the treatment of migraine. ETHICS AND DISSEMINATION: The review and meta-analysis will not require ethical approval because personal information from individuals will not be involved. The results will be published in a peer-reviewed journal.

Comparative Effectiveness and Safety of Concomitant Treatment with Chuna Manual Therapy and Usual Care for Whiplash Injuries: A Multicenter Randomized Controlled Trial.

OBJECTIVES: We aimed to compare the effectiveness and safety of Chuna manual therapy combined with usual care to those of usual care alone for treating whiplash injuries. DESIGN: A two-arm, parallel, assessor-blinded, multicenter pragmatic randomized clinical trial. SETTING: Three hospitals in Korea. PARTICIPANTS: Overall, 132 participants between 19 and 70 years of age, involved in traffic accidents and treated at three hospitals in Korea, >2 but <13 weeks prior to enrollment, with neck pain consistent with whiplash-associated disorder grades I and II and a numeric rating scale score ≥5 were included. INTERVENTIONS: Participants were equally and randomly allocated to the Chuna manual therapy and usual care (n = 66) or usual care (n = 66) groups and underwent corresponding treatment for three weeks. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the number of days to achieve a 50% pain reduction. Secondary outcomes included areas under the 50% numeric rating scale reduction curve: pain, disability, quality of life, and safety. RESULTS: The Chuna manual therapy + usual care group (23.31 ± 21.36 days; p = 0.01) required significantly fewer days to achieve 50% pain reduction compared to the usual care group (50.41 ± 48.32 days; p = 0.01). Regarding pain severity, functional index, and quality of life index, Chuna manual therapy and usual care were more effective than usual care alone. Safety was acceptable in both groups. CONCLUSIONS: In patients with subacute whiplash injury, Chuna manual therapy showed a rapid rate of recovery, high effectiveness, and safety.

Adaptation and Dissemination of Korean Medicine Clinical Practice Guidelines for Traffic Injuries.

In South Korea, car insurance that includes medical coverage of traditional Korean medicine (TKM) has increased exponentially. Clinical practice guidelines (CPG) for traffic injuries were established in 2016. We aimed to revise and update de novo CPG and distribute the adapted CPG to TKM practitioners and patients. Clinical key questions from previous CPG were identified and updated regarding the grade of recommendation and level of evidence using additional evidence from the literature obtained through a systematic search and the use of the Grading of Recommendations Assessment, Development, and Evaluation methodology. The dissemination and implementation of the updated CPG were conducted at the CPG Center of Korean Medicine. Ultimately, 25 recommendations based on 13 clinical key questions were developed: 2 for diagnosis, 22 for TKM treatments, and 1 for prognosis. After recognition by professional societies and certification by the CPG Center of Korean Medicine, leaflets, card news, and infographics for TKM doctors in South Korea were produced and distributed. These are the only TKM CPG for patients who have experienced traffic injuries. They are expected to contribute to standardized and evidence-based treatment using TKM and similar interventions. Moreover, disseminating the adapted CPG will promote treatment reliability and strengthen insurance coverage.

Cost-Effectiveness of Chuna Manual Therapy and Usual Care, Compared with Usual Care Only for People with Neck Pain following Traffic Accidents: A Multicenter Randomized Controlled Trial.

This is the first cost-effectiveness analysis of Chuna manual therapy (CMT) plus usual Korean traditional medicine for traffic accident victims using a randomized controlled trial. A total of 132 participants were equally allocated to the intervention group receiving 6-11 sessions of CMT plus usual Korean traditional medicine care for three weeks or usual care including acupuncture, cupping, herbal medicine, moxibustion, and traditional physiotherapy at three hospitals. At 12 weeks, from a healthcare perspective, the intervention group had significantly higher costs (mean (SD), $778 (435) vs. $618 (318); difference, $160; 95% CI, $15 to $289; p = 0.005). From a societal perspective, total costs were insignificantly lower in the intervention group (mean (SD), $1077 (1081) vs. $1146 (1485); difference, $-69; 95% CI, $-568 to $377; p = 0.761). The intervention group dominated, with significantly higher QALYs gained at lower overall cost with a 72% chance of being cost-effective. From a societal perspective, the intervention was cost-saving for individuals who had neck pain after car accidents, although it was not cost-effective from the healthcare perspective ($40,038 per QALY gained). Findings support use of CMT as an integrated care treatment for whiplash from a societal perspective. Further studies with larger sample sizes are needed to determine cost-effectiveness in other cultural contexts.

Efficacy of acupuncture for whiplash injury: A protocol for systematic review and meta-analysis.

BACKGROUND: Studies in both Eastern & Western countries such as the United States and Europe have evaluated the efficacy of acupuncture for whiplash injury or whiplash-associated disorder (WAD). However, no systematic reviews on the effectiveness of acupuncture on WAD have been conducted since 2014. Therefore, we are planning an updated systematic review of studies published since 2014 to overcome the limitations of existing evidence. METHODS: Literature will be identified from searches of relevant databases, including international databases such as PubMed, Ovid-Medline, Embase, The Cochrane Library, and China National Knowledge Infrastructure and Korean databases such as Korea Med, Korean Studies Information Service System, Oriental Medicine Advanced Searching Integrated System, and National Digital Science Library. Only randomized controlled trials using acupuncture or electro-acupuncture for whiplash injury will be included. The primary outcomes will be the visual analog scale or numerical rating scale of the neck pain, while the secondary outcome is the range of motion of the neck. The risk of bias for individual papers will be assessed by two independent investigators using the Cochrane "Risk of Bias" assessment tool. DISSEMINATION: We plan to report the results of the study in a peer-reviewed journal after completing the research. In addition, we expect this study to provide invaluable information to clinicians treating patients with WAD with acupuncture or electro-acupuncture. TRIAL REGISTRATION NUMBER: PROSPERO 2021: CRD42021261595. Registered on 18 July 2021. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=261595.

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial.

BACKGROUND: Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with long-term medication, interest in taichi as an exercise treatment method has increased recently in Korean medical practice. Numerous studies have suggested that taichi can be used to treat various diseases and that is can affect psychosomatic factors such as anxiety. This study aims to evaluate the effect of taichi in reducing blood pressure among grade 1 hypertensive patients. METHODS/DESIGN: In this randomized, active-controlled, assessor-blinded, two parallel-armed trial, 80 grade 1 hypertension patients will be recruited and randomly assigned to the usual care group or to the taichi group (n = 40 in each group). Subjects who voluntarily sign a study agreement will be educated in managing their own blood pressure by restricting salt intake, losing weight, moderating alcohol consumption, performing exercise, and regulating dietary intake at their first visit. In addition to self-management, the taichi group will perform two 60-min taichi sessions per week for a total of 8 weeks. Blood pressure will be measured as the primary outcome. In addition, body composition, heart rate, and the perceived intensity and difficulty of the exercise will be measured as secondary outcomes. DISCUSSION: This study is a randomized controlled trial of taichi, which is not widely practiced in Korea. It may provide valuable data on the effects of taichi on hypertension, which will inform non-pharmaceutical treatment options for this disorder. TRIAL REGISTRATION: Clinical Research Information Service, KCT0003632. Registered on 18 March 2019.

Jakyakgamcho-tang in the relief of delayed-onset muscle soreness in healthy adults: study protocol for a randomized, double-blind, placebo-controlled, crossover design clinical trial.

BACKGROUND: Muscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries. Therefore, various therapeutic strategies have been studied to help recovery after exercise. Jakyakgamcho-tang (JGT) is a widely prescribed herbal medicine to treat muscle pain and cramps in traditional Eastern medicine. The aim of this study is to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise. METHODS: This study is a randomized, double-blind, placebo-controlled, crossover design clinical trial. A total of 30 healthy male adults will be recruited. Subjects who voluntarily wish to participate in this study will be hospitalized for 4 days. On the first day, the subjects will perform a standardized treadmill exercise for 1 h to induce DOMS. After the exercise, the subjects will take either JGT or a placebo for 3 days. After a more than 1 week wash-out period, the subjects will repeat the same process with the other drug. Pain intensity, calf circumference, and pain threshold will be measured as outcome measures. Blood tests and blood pressure will be measured as safety assessments. In addition, blood tests for muscle damage and inflammation markers, such as creatine kinase, interleukin-6, and C-reactive protein, will be analyzed. DISCUSSION: This will be the first trial to assess the effect of JGT on exercise-induced muscle soreness. Our findings will provide valuable data to determine the clinical effects of JGT on DOMS. TRIAL REGISTRATION: Clinical Research Information Sevice, KCT0003457. Registered on 29 January 2019.

Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial.

Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute LBP. We conducted a parallel, two-armed, multi-centered, assessor blinded, pragmatic, randomized controlled trial at four major Korean medical hospitals. Overall, 194 patients were randomly allocated to either CMT plus UC (n = 97) or UC alone (n = 97), for six weeks of treatment and six months follow-up. The primary outcome was measured using the numerical rating scale (NRS) of LBP intensity at 7 weeks. Secondary outcomes included NRS of leg pain, Oswestry Disability Index (ODI) for functional disability, patient global impression of change (PGIC) scale, and safety. A total of 194 patients were included in the intention-to-treat analysis, and 174 patients provided complete data for the primary outcome. At 7 weeks, clinically significant differences between groups were observed in the NRS of LBP (CMT + UC: -3.02 ± 1.72, UC: -1.36 ± 1.75, p < 0.001), ODI scores (CMT + UC: -5.65 ± 4.29, UC: -3.72 ± 4.63, p = 0.003), NRS of leg pain (CMT + UC: -2.00 ± 2.33, UC: -0.44 ± 1.86, p < 0.0001), and PGIC (CMT + UC: -0.28 ± 0.85, UC: 0.01 ± 0.66, p = 0.0119). Mild to moderate safety concerns were reported in 21 subjects. CMT plus UC showed higher effectiveness compared to UC alone in patients with non-acute LBP in reducing LBP and leg pain and in improving function with good safety results using a powered sample size and including mid-term follow-up.

Korean medicine registry for low back pain - A study protocol for prospective observational multi-center study (KLOS).

BACKGROUND: Low back pain (LBP) is a major burden in Korea. Despite its high prevalence, the government and the public health sector do not address the specific evidences of symptom control and prevention of LBP to reduce long-term healthcare costs and increase the quality of life. Thus, the Korean medicine sector encourages to collection and analysis of the medical utilization pattern of patients with LBP in Korea to provide evidences of LBP control strategy as well as political decisions. METHODS: KLOS, a prospective, multi-center, patient registry pilot study will collaborate with 7 traditional Korean medicine hospitals and recruit patients with LBP into the registry. A total of 150 eligible patients with new episodes of LBP, who visit a Korean hospital without any other treatment history, will be enrolled in the registry. After enrollment, we will collect the individual characteristics of each patient, such as pain intensity, LBP-related daily disability, anthropometrics, and Health-Related Quality of Life (HRQoL) at baseline and FU1 and FU2. We will also access the patients' clinical and administrative electronic records to analyze the pattern of patients' resource utilization. Overall, the aims of KLOS are to (1) explore the general characteristics of patients with new episodes of LBP and (2) evaluate the efficacy and safety of various Korean medicine treatments for LBP, based on nationwide registry outcome collecting process. DISCUSSION: The first pilot study of prospective, multi-center registry of newly diagnosed LBP patients in traditional Korean medicine hospitals. The result of this study may show the current status of LBP patients who receive Korean medicine treatments and provide evidences for reasonable decision-making on Korean medicine healthcare policy in the future. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT02418286.

Comparative effectiveness of Chuna manual therapy versus conventional usual care for non-acute low back pain: a pilot randomized controlled trial.

BACKGROUND: Low back pain (LBP) is common, with a lifetime prevalence of 80%, and as such it places substantial social and economic burden on individuals and society. Chuna manual therapy (CMT) combines aspects of physiology, biodynamics of spine and joint motion, and basic theory of movement dynamics. This study aimed to test the comparative effectiveness and safety of CMT for non-acute LBP. METHODS: A three-arm, multicenter, pragmatic, randomized controlled pilot trial was conducted from 28 March 2016 to 19 September 2016, at four medical institutions. A total of 60 patients were randomly allocated to the CMT group (n = 20), usual care (UC) group (n = 20), or combined treatment (CMT + UC) group (n = 20), and received the relevant treatments for 6 weeks. The primary outcome was a numeric rating scale (NRS) representation of LBP intensity, while secondary outcomes included NRS of leg pain, Oswestry disability index (ODI), Patient Global Impression of Change (PGIC), the EuroQol-5 dimensions (EQ-5D), lumbar range of motion, and safety. RESULTS: A total of 60 patients were included in the intention-to-treat analysis and 55 patients (CMT, 18; UC, 18; CMT + UC, 19) were included in the per-protocol analysis (drop-out rate 5.3%). Over the treatment period there were significant differences in the NRS score for LBP (CMT mean - 3.28 (95% CI - 4.08, - 2.47); UC - 1.95 (- 2.82, - 1.08); CMT + UC - 1.75 (- 2.70, - 0.80), P < 0.01) and the ODI scores in each group (CMT - 12.29 (- 16.86, - 7.72); UC - 10.34 (- 14.63, - 6.06); CMT + UC - 9.27 (- 14.28, - 4.26), P < 0.01). The changes in other secondary outcomes did not significantly differ among the three groups. Sixteen minor-to-moderate safety concerns were reported. CONCLUSIONS: Our results suggest that CMT has comparative efficacy for non-acute LBP and is generally safe. As this was a preliminary study, a well-powered (over 192 participants) two-arm (CMT versus UC) verification trial will be performed to assess the generalizability of these results. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0001850 . Registered on 12 March 2016.

Analysis of Herbal Medicine Prescriptions for Patients in An Academic Korean Medical Hospital: A Cross Sectional Study of Electronic Medical Records (2010-2013).

OBJECTIVE: To obtain fundamental information for the standardization of herbal medicine in Korea. METHODS: We analyzed the herbal medicine prescription data of patients at the Pusan National University Korean Medicine Hospital from March 2010 to February 2013. We used the Dongui-Bogam (Dong Yi Bao Jian) to classify prescribed herbal medicines. RESULTS: The study revealed that the most frequently prescribed herbal medicine was 'Liuwei Dihuang Pill (LWDHP, )' which was used for invigorating 'Shen (Kidndy)-yin'. 'LWDHP' was most frequently prescribed to male patients aged 50-59, 60-69, 70-79 and 80-89 years, and 'Xionggui Tiaoxue Decoction (XGTXD, )' was most frequently prescribed to female patients aged 30-39 and 40-49 years. According to the International Classification of Diseases (ICD) codes, 'Diseases of the musculoskeletal system and connective tissue' showed the highest prevalence. 'LWDHP' and 'XGTXD' was the most frequently prescribed in categories 5 and 3, respectively. Based on the percentage of prescriptions for each sex, 'Ziyin Jianghuo Decoction ()' was prescribed to mainly male patients, and 'XGTXD' with 'Guima Geban Decoction ()' were prescribed to mainly female patients. CONCLUSION: This study analysis successfully determined the frequency of a variety of herbal medicines, and many restorative herbal medicines were identified and frequently administered.

Electroacupuncture as a complement to usual care for patients with non-acute low back pain after back surgery: a pilot randomised controlled trial.

OBJECTIVES: The aim of this pilot study was to estimate the sample size for a large pragmatic study of the comparative effectiveness of electroacupuncture (EA) for low back pain (LBP) after back surgery. DESIGN: A randomised, active-controlled, assessor-blinded trial. PARTICIPANTS: Patients with recurrent or persistent LBP, defined as a Visual Analogue Scale (VAS) score of ≥50 mm, with or without leg pain after back surgery. INTERVENTIONS: Patients were randomised to an EA plus usual care (UC) group or to a UC alone group at a 1:1 ratio. Patients assigned to each group received UC, including drug therapy, physical therapy and back pain education, twice a week for 4 weeks; those assigned to the EA plus UC group additionally received EA. OUTCOME MEASURES: The primary outcome was severity of LBP as measured by VAS. Secondary outcomes included back pain-related disability, assessed using the Oswestry Disability Index (ODI) and quality of life, assessed using the EuroQol Five Dimensions (EQ-5D) questionnaire. Statistical analysis was performed using paired and independent t-tests. A p value of <0.05 was considered statistically significant. RESULTS: Thirty-nine patients were allocated to receive EA plus UC (n=18) or UC alone (n=21). There was no statistically significant difference in VAS or EQ-5D scores between the two groups, but there was a significant decrease in ODI scores (p=0.0081). Using G*Power, it was calculated that 40 participants per group would be needed for a future trial according to VAS scores. Considering for a 25% dropout rate, 108 participants (54 per group) would be needed. CONCLUSIONS: A future trial addressing the risk of bias and including the estimated sample size would allow for better clinical assessment of the benefits of EA plus UC in treatment of patients with non-acute pain after back surgery. TRIAL REGISTRATION NUMBER: NCT01966250; Results.

Chuna (or Tuina) Manual Therapy for Musculoskeletal Disorders: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVE: To review the literature and systematically evaluate the effectiveness of Chuna (or Tuina) manual therapy (C[T]MT) on pain and function for musculoskeletal disorders. METHODS: We searched 15 English, Chinese, Japanese, and Korean databases using relevant keywords. All randomized controlled trials (RCTs) of C(T)MT for musculoskeletal disorders were considered, and we limited analyses to studies with a low-risk bias for randomization and/or allocation concealment. RESULTS: Sixty-six RCTs with 6,170 participants were included. One sham-controlled RCT showed that C(T)MT relieved pain more effectively than a sham control (SMD -3.09 [-3.59, -2.59]). For active-controlled RCTs, pooled meta-analysis showed that C(T)MT had statistically significant effects on pain reduction, especially compared to traction (P < 0.00001), drugs (P = 0.04), and physical therapies (P < 0.0001). For functional improvement, combined effects of C(T)MT with drugs (P = 0.04) and traction (P = 0.05) also showed similar positive effects. CONCLUSIONS: This systematic review suggests that C(T)MT is safe and effective for pain reduction and functional improvement for musculoskeletal diseases; however, the evidence for functional improvement was not as strong as for pain reduction. For future studies, high-quality RCTs such as sham-controlled studies with standardized interventions are needed to provide sufficient evidence on the effects of C(T)MT for musculoskeletal diseases. Protocol registration number is CRD42016038307 04/07/2016.