Cross-cultural adaptation of the Korean Synkinesis Assessment Questionnaire: A validation study.

Objective: The Synkinesis Assessment Questionnaire (SAQ) is a reliable tool to assess synkinesis symptoms; however, it is yet to be validated in Korea. Thus, this study aimed to translate and validate the Korean SAQ. Methods: This validation study was set in a clinic in Seoul, Korea, that provides general integrative medicine services. A total of 100 participants with facial palsy were enrolled. Participants completed the SAQ, House-Brackmann grade (HB grade), Sunnybrook Facial Grading System (SB), and Facial Disability Index (FDI). The forward-backward translation method was followed. Of the 100 participants, 31 underwent a second assessment for test-retest reliability. Internal consistency and test-retest reliability were evaluated using Cronbach's alpha coefficient. The construct validity of the Korean version of the SAQ was tested using Spearman's rank correlation coefficient. Results: The internal consistency score for the SAQ was 0.789, and the test-retest reliability score was 0.787. According to Spearman's rank correlation coefficient, the SAQ correlations to the synkinesis subdomain of SB score, total SB score, HB grade, and physical function domain in the FDI score were 0.366 (p < .001), -0.386 (p < .001), 0.315 (p = .001), and -0.269 (p = .007), respectively. All values were statistically significant. Conclusions: The Korean SAQ is a valid and reliable tool used to evaluate synkinesis in patients with facial palsy. Level of Evidence: Level 3.

Association of Cost and Medical Service Satisfaction with Korean and Conventional Medicine Use before and after Surgery in Postsurgical Patients: A Questionnaire Survey of Korean Patients with Postsurgical Pain Visiting Korean Medicine Hospitals.

This study aimed to assess the costs, health status, and medical service satisfaction with Korean and conventional medicine use before and after surgery of patients visiting Korean medicine hospitals for postsurgical musculoskeletal pain. The study population comprised patients who visited KM hospitals for the first time between June and November 2017 for persistent or recurrent pain and discomfort after low back, neck, shoulder, or knee surgery. Various validated questionnaires were used to collect data. A total of 100 participants were enrolled, and the majority had undergone low back surgery (n = 82). The participants had received 1.3 ± 0.7 magnetic resonance imaging (MRI) examinations and 2.4 ± 2.8 X-rays before surgery. Conventional interventions used before surgery were physical therapy (43%), medications (34%), and injections (28%), in descending order, while 48% of patients reported having received acupuncture 51.3 ± 81.1 times. The mean satisfaction score for surgery was 5.5 ± 2.8 points based on a 9-point Likert scale, while that for KM-based interventions was 6.3 ± 1.7 points. With respect to health-related information, the mean scores were 6.0 ± 2.2 points on the Numeric Rating Scale (NRS), 0.6 ± 0.2 points on the 5-Level EuroQol-5 Dimension (EQ-5D-5L), and 15.3 ± 10.2 on Beck's Depression Index II (BDI-II). The mean score on the Oswestry Disability Index (ODI) in patients with low back pain was 40.1 ± 19.2 points. Work impairment, as measured using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH), was 62.5 ± 47.8%, while activity impairment was 5.9 ± 2.6%. Participants tended to show low satisfaction regarding surgery and high preference for KM-based interventions. In particular, low back surgery patients reported high ODI scores, indicating high dysfunctional levels and poor prognosis after surgery. It can be inferred that it is therefore important to provide appropriate presurgical and postsurgical care for patients with musculoskeletal pain to improve pain, function, and quality of life.

Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial.

INTRODUCTION: Doin therapy is a manual therapy used in Korean rehabilitation medicine. Recently, the use of acupuncture with Doin has increased in clinics and clinical trials have demonstrated its effects. However, well-designed studies examining the efficacy and cost-effectiveness of acupuncture with Doin therapy are rare. METHODS AND ANALYSIS: This multicentre, assessor-blinded, randomised controlled trial with two parallel groups aims to evaluate the clinical effects and cost-effectiveness of acupuncture with Doin therapy. A total of 124 patients (with a neck pain duration of 6 months or longer and a Numeric Rating Scale ≥5) will be recruited at five Korean medicine hospitals. Patients will be randomly allocated to acupuncture with Doin therapy (n=62) and acupuncture alone (n=62) for 5 weeks of treatment. This study will be carried out with outcome assessor and statistician blinding. The primary outcome measure will consist of improvement in neck pain using the Visual Analogue Scale at 6 weeks. The secondary outcomes including measures of pain, functional disability, health-related quality of life and economic evaluation will be conducted at 6 weeks, and 3, 6, 9 and 12 months after treatment ETHICS AND DISSEMINATION: The project is approved by the Institutional Review Board (IRB) of the Jaseng Hospital of Korean Medicine and the Kyung Hee University Korean Medicine Hospital at Gangdong. Dissemination will occur after the findings from this study are published in other peer reviewed journals. TRIAL REGISTRATION NUMBERS: NCT03558178; KCT0003068; Pre-results.

Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial.

BACKGROUND: Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints. METHODS/DESIGN: This study is the protocol for a two-armed parallel, assessor-blinded, multicenter, randomized controlled trial. A total 108 patients with chronic neck pain (time to onset ≥ 3 months, numeric rating scale [NRS] of neck pain ≥ 5) will be recruited at five Korean medicine hospital sites. Participants will be allotted to one of two groups (n = 54, respectively): the Chuna manual therapy group, and the usual care (conventional physical therapy and medication treatment) group. Ten sessions of Chuna manual therapy or usual care will be administered twice a week for five weeks. Since the study design does not permit patient or physician blinding, the outcome assessor and statistician will be blinded. The primary outcome will be the visual analogue scale (VAS) of neck pain at 5 weeks after randomization. Secondary outcomes include the VAS of radiating arm pain, NRS of neck pain and radiating arm pain, Vernon-Mior neck disability index (NDI), Northwick Park neck pain questionnaire (NPQ), EuroQol-5 Dimension (EQ-5D), EQ-VAS, patient global impression of change (PGIC), economic evaluation, adverse effects, and drug consumption. Follow-up outcome assessments will be conducted at 3, 6, 9, and 12 months after randomization. DISCUSSION: This study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0002732 . Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785 . Registered on 27 September 2017.

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

BACKGROUND: Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery. METHODS/DESIGN: This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score ≥ 50 mm will be randomly assigned to either the EA with UC group (n = 54) or the UC group (n = 54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization. DISCUSSION: The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939 . Registered on 8 June 2016.

Current practice and usual care of major cervical disorders in Korea: A cross-sectional study of Korean health insurance review and assessment service national patient sample data.

Neck pain is a highly common condition and is the 4th major cause of years lived with disability. Previous literature has focused on the effect of specific treatments, and observations of actual practice are lacking to date. This study examined Korean health insurance review and assessment service (HIRA) claims data to the aim of assessing prevalence and comparing current medical practice and costs of cervical disorders in Korea.Current practice trends were determined through assessment of prevalence, total expenses, per-patient expense, average days in care, average days of visits, sociodemographic characteristics, distribution of medical costs, and frequency of treatment types of high frequency cervical disorders (cervical sprain/strain, cervical intervertebral disc displacement [IDD], and cervicalgia).Although the number of cervical IDD patients was few, total expenses, per-patient expense, average days in care, and average days of visits were highest. The proportion of women was higher than men in all 3 groups with highest prevalence in the ≥50s middle-aged population for IDD compared to sprain/strain. Primary care settings were commonly used for ambulatory care, of which approximately 70% chose orthopedic specialist treatment. In analysis of medical expenditure distribution, costs of visit (consultation) (22%-34%) and physical therapy (14%-16%) were in the top 3 for all 3 disorders. Although heat and electrical therapies were the most frequently used physical therapies, traction use was high in the cervical IDD group. In nonnarcotics, aceclofenac and diclofenac were the most commonly used NSAIDs, and pethidine was their counterpart in narcotics.This study investigated practice trends and cost distribution of treatment regimens for major cervical disorders, providing current usage patterns to healthcare policy decision makers, and the detailed treatment reports are expected to be of use to clinicians and researchers in understanding current usual care.

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.

Medical service use and usual care of common shoulder disorders in Korea: a cross-sectional study using the Health Insurance Review and Assessment Service National Patient Sample.

OBJECTIVES: This study examined National Health Insurance claims data to investigate the epidemiology of shoulder disorders in Korea. Detailed information on medical services and related costs was assessed by major shoulder disorder category. DESIGN AND SETTING: The 2014 National Patient Sample dataset provided by the Health Insurance Review and Assessment Service was analysed. Among shoulder-related diagnosis codes, adhesive capsulitis of the shoulder (ACS), rotator cuff syndrome (RCS) and shoulder impingement syndrome (SIS) categories were of highest prevalence. Sociodemographic characteristics and medical service use, frequency and medical costs regarding common shoulder disorders were evaluated. RESULTS: The majority of patients with shoulder disorder received ambulatory care (97%). Total and per-patient expenses were highest in patients with RCS. The number of inpatients with RCS was more than twice that of the other two groups, and patients with RCS were more likely to receive surgical management compared with patients with ACS and SIS. Prevalence of shoulder disorders was highest among subjects in their 50s for all three groups. Primary care physicians treated 75.80% of patients with ACS, 56.99% of patients with RCS and 48.06% of patients with SIS, respectively, outlining the difference in medical institution usage patterns. In all three groups, the highest proportion of patients visited orthopaedic surgeons out of medical departments. In the ACS and SIS groups, cost of visits (consultations) took up the largest part of total expenses at 32.30% and 18.88%, respectively, while cost of procedure/surgery constituted the largest portion in patients with RCS (37.77%). The usage proportion of subcutaneous or intramuscular and intra-articular injections ranged between 20% and 30% for outpatients in all three groups. CONCLUSIONS: Medical service use, frequency and cost distributions relating to major shoulder disorders in Korea were assessed using nationwide claims data. These findings are expected to aid policy-makers as well as researchers and practitioners as basic healthcare data.

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

BACKGROUND: While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. METHODS/DESIGN: This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. DISCUSSION: This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.

STUDY DESIGN: .: Prospective observational 1-year study. OBJECTIVE: .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient. SUMMARY OF BACKGROUND DATA: .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined. METHODS: .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach. RESULTS: .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively. CONCLUSION: .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients. LEVEL OF EVIDENCE: 3.

Evaluation of use and cost of medical care of common lumbar disorders in Korea: cross-sectional study of Korean Health Insurance Review and Assessment Service National Patient Sample data.

OBJECTIVES: To assess medical care and costs of the 3 highest prevalence lumbar disorders-non-specific low back pain (nLBP), intervertebral disc disorder (IDD) and spinal stenosis (SS)-from national billing data to provide basic information for standards of appropriate management. DESIGN: Retrospective analysis of National Health Insurance National Patient Sample data provided by the Korean Health Insurance Review and Assessment Service (HIRA). SETTING: 2011 claims data from all medical institutions which filed billing statements to HIRA. PARTICIPANTS: A total of 135 561 patients with lumbar disorder who received medical services during 2011. OUTCOME MEASURES: Patient characteristics, medical procedures, medication, cost, injection and surgery. RESULTS: In the nLBP and IDD groups, the 50-59 age range had the highest prevalence, whereas prevalence increased with age in SS. All 3 groups showed a higher percentage in women. The average treatment cost was 196 552 KRW in the nLBP and 362 050 KRW in the IDD group, and highest in the SS group at 439 025 KRW. While in the nLBP group women spent more on medical expenses, in the other 2 groups men showed higher expenditure. Expenditure grew with age in the nLBP and SS groups, whereas that of the IDD group peaked in their 40s. Analgesics were used in 73.43% of patients with nLBP, 82.64% of patients with IDD and 86.46% of patients with SS, and opioids in 4.12% of patients with IDD and 5.36% of patients with SS. Surgery rates were highest in the SS group at 4.85%, with 0.9% for nLBP and 4.59% for IDD. The most frequent injection code was lumbar/caudal epidural nerve block. Expenditure and surgery rates were higher in the injection than in the non-injection subgroup in all 3 groups. CONCLUSIONS: Patterns of medical care of most frequent lumbar disorders from HIRA data showed significant difference between groups and provide a basic standard for future usual care guidelines linked with health policy and budget appropriation.