National Health Insurance Data Analysis for the Second-Wave Development of Korean Medicine Clinical Practice Guidelines in South Korea.

Objectives: After the evidence-based Korean medicine clinical practice guidelines (KM-CPGs) for 30 targeted diseases were developed in 2021, 34 diseases have been proposed for the second-wave development of the KM-CPGs. The purpose of this study was to investigate the development priorities of the candidate diseases into the second-wave development of KM-CPGs in south Korea. Methods: In this study, we analyzed the Health Insurance Review and Assessment Service National Patient Sample data from 2017 to 2018 to determine the demand and economic importance of the candidates for the second-wave development of KM-CPGs in real-world clinical settings in Korea. Results: The annual number of visits and patients, annual healthcare expenditure per patient, and healthcare expenditure per institution were analyzed. Musculoskeletal disorders, including sciatica and adhesive capsulitis of the shoulder, were the most important topics regarding the number of visits and patients and annual healthcare expenditure per institution. Specifically, sciatica (52.05% of the total number of visits, 48.34% of the total number of patients, and 42.12% of the total treatment expenditure per institution) showed overwhelmingly high proportions. However, cerebral palsy (36.03% of the total number of inpatient visits and 24.55% of the total number of inpatient patients) was a more important topic in inpatient clinical settings than musculoskeletal conditions or cancer, and healthcare expenditure per patient in this topic had the highest ranking. Furthermore, fractures were found to be highly important in inpatient clinical settings. No patients had influenza A virus infection or posttraumatic stress disorders who visited the KM medical institution of interest. Conclusion: This study highlights the gap between the real-world clinical setting and the research field in some topics. The results of this study can provide guidance for the second-wave development of KM-CPGs in the future.

The effect of continuity of care on medical costs in patients with chronic shoulder pain.

Unnecessary surgery could be prevented through continuity of care (COC). The present study aimed to investigate the relationships between COC, surgery and cost associated with chronic shoulder pain. We used the Health Insurance Review and Assessment Service national patient sample (HIRA-NPS) in 2017. A total of 1717 patients were included. Bice-Boxerman Continuity of Care Index was used as the indicator for measuring the COC. Occurrence of surgery, associated costs, and direct medical costs were analysed. Logistic regression, a two-part model with recycled predictions and generalized linear model with gamma distribution were used. The majority of patients were 40-65 years old (high COC: 68.4%; low COC: 64.4%). The odds ratio (OR) for surgery was 0.41 in the high-COC group compared to the low COC group (95% CI, 0.20 to 0.84). Direct medical cost was 14.09% (95% CI, 8.12% to 19.66%) and 58.00% lower in surgery cost (95% CI, 57.95 to 58.05) in the high-COC group. Interaction with COC and shoulder impingement syndrome was significant lower in direct medical cost (15.05% [95% CI, 1.81% to 26.51%]). High COC was associated with low medical cost in patients diagnosed with chronic shoulder pain.

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.

Acromioplasty rates in patients with shoulder disorders with and without acupuncture treatment: a retrospective propensity score-matched cohort study.

OBJECTIVE: This retrospective propensity score-matched cohort study aimed to examine the frequency of acromioplasty among patients with shoulder disorders receiving and not receiving acupuncture, based on Korea National Health Insurance Service-National Sample Cohort (NHIS-NSC) data. METHODS: We included cases of high-frequency shoulder disorders-adhesive capsulitis, rotator cuff syndrome, shoulder impingement syndrome, and sprain and strain of the shoulder joint-stratified from the Korea NHIS-NSC database between 2002 and 2013; cases were classified into two groups based on a history of acupuncture treatment performed at least twice within 6 weeks (acupuncture group: n = 111,561; control group: n = 71,340). We examined propensity scores and hazard ratios (HRs) for the frequency of acromioplasty, within 2 years of the first treatment or first examination in the acupuncture and control groups, respectively; cumulative survival rates were estimated using Kaplan-Meier survival analysis. RESULTS: Following propensity score matching, no differences were observed between the acupuncture and control groups for variables including sex, age, income and the Charlson comorbidity index. In addition, the incidence rates of acromioplasty within 2 years were lower in the acupuncture group than in the control group (HR 0.264; 95% confidence interval 0.224-0.311). Based on differences in sensitivity analyses for the numbers of acupuncture sessions and treatment duration, the frequency of acromioplasty within 2 years was lower in the acupuncture group than in the control group. CONCLUSION: This study found that the frequency of acromioplasty was reduced in patients with shoulder disorders who had been treated with acupuncture. Although the findings need to be verified by prospective randomized clinical trials, these results imply that acupuncture may be effective at reducing the incidence rate of shoulder surgery.

Cervical surgery rate in neck pain patients with and without acupuncture treatment: a retrospective cohort study.

OBJECTIVE: Surgical treatment of neck pain often entails high costs and adverse events. The present cohort study investigated whether utilisation of acupuncture in neck pain patients is associated with a reduced rate of cervical surgery. METHODS: The Korean National Health Insurance Service National Sample Cohort (NHIS-NSC) database was retrospectively analysed to identify the 2 year incidence of cervical surgery in Korean patients suffering neck pain from 2004 to 2010. The incidence was calculated and compared between patients receiving and not receiving acupuncture treatment using Cox proportional hazards models. Cumulative survival rates were compared using Kaplan-Meier survival analysis. RESULTS: The acupuncture and control groups included 50 171 and 128 556 neck pain patients, respectively. A total of 50 161 patients were selected in each group following propensity score matching with regard to sex, age, income and Charlson comorbidity index. The hazard ratio (HR) for surgery within 2 years was significantly lower in the acupuncture group compared with the control group (HR 0.397, 95% CI 0.299 to 0.527). In addition, subgroup analyses according to gender, age and income revealed consistent results for both men (HR 0.337, 95% CI 0.234 to 0.485) and women (HR 0.529, 95% CI 0.334 to 0.836); the results were consistently observed across all age and income strata. Sensitivity analysis with varying numbers of acupuncture treatments and treatment course duration also consistently indicated lower HRs for surgery within 2 years in the acupuncture group compared with the control group. CONCLUSIONS: A significantly lower HR for cervical surgery was observed in neck pain patients following acupuncture treatment. Acupuncture treatment may therefore be an effective method for managing neck pain, and has the potential to mitigate unnecessary surgery. These findings need to be confirmed by prospective studies.

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.

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.

Electroacupuncture Enhances the Antiallodynic and Antihyperalgesic Effects of Milnacipran in Neuropathic Rats.

BACKGROUND: Milnacipran, a selective serotonin/norepinephrine-reuptake inhibitor, has been shown to elicit a beneficial effect in various models of neuropathic pain. Previously, we reported that repetitive electroacupuncture (EA) significantly ameliorates neuropathic pain induced by L5 spinal nerve ligation (SNL). In the present study, we sought to determine whether a single treatment with EA produces analgesia and whether EA in combination with a subeffective dosage of milnacipran exhibits an additive effect in SNL rats. METHODS: Mechanical allodynia and thermal hyperalgesia were assessed by measuring paw withdrawal thresholds and latencies in response to mechanical and thermal stimuli, respectively, 1 day before and 5 days after neuropathic surgery. In addition, on day 5 post-SNL, time courses of behaviors were assessed at 0, 1, 2, 4, 6, and 8 hours after intrathecal (i.t.) milnacipran (1, 5, and 20 µg) administration. EA (10 Hz/1 mA) was administered at the ST36 and GB34 acupoints for 30 minutes on day 5 and the time courses of behaviors were also assessed at 0, 1, 2, 4, 6, and 8 hours later. Similarly, when treated in combination (milnacipran [5 µg, i.t.] and EA [10 Hz/1 mA]), time courses of behaviors were assessed at the same time points. RESULTS: Intrathecal injection of milnacipran at 5 or 20 µg exerted dose-dependent effects on thermal hyperalgesia but had similar efficacies on mechanical allodynia. Furthermore, EA itself detectably attenuated hyperalgesia at 4 hours after the application, but no statistically significant difference was found in mechanical allodynia. Importantly, cotreatment with EA and milnacipran (5 µL) produced more potent antiallodynic and antihyperalgesic effects than those obtained from EA or milnacipran alone at 1, 2, and 4 hours after treatment, indicating an additive effect. In addition, the analgesic effect of EA plus milnacipran was almost completely abolished by the catecholamine neurotoxin 6-hydroxydopamine hydrobromide (25 µg), which depletes spinal norepinephrine, and by yohimbine (an α2-adrenoceptor antagonist, 30 µg, i.t.). Somewhat surprisingly, the analgesic effect of milnacipran plus EA lasted for 6 hours. CONCLUSIONS: The study shows that, in male rats with SNL, spinal administration of milnacipran effectively alleviates mechanical allodynia and thermal hyperalgesia, and that a single treatment of EA has an antihyperalgesic effect. Furthermore, our findings suggest that coapplication of EA and milnacipran enhanced antiallodynia and antihyperalgesia by activating spinal noradrenergic systems coupled with spinal α2-adrenoceptors and prolongs the duration of analgesia.

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

INTRODUCTION: Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described. METHODS AND ANALYSIS: This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250.