Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial.

Purpose: Postherpetic neuralgia (PHN) is the most common chronic complication of herpes zoster, associated with poor quality of life and increased patient and healthcare resource expenditure. This randomized controlled trial aims to evaluate the efficacy and safety of SIKD1977 (Sogeonjungtang) in combination with standard treatment and estimate an effective dose for treating PHN. Patients and Methods: This is a protocol for a randomized, placebo-controlled, double-blind, multicenter trial. A total of 90 eligible participants with PHN will be recruited from three hospitals and randomly allocated to high-dose group, low-dose group, or placebo group in a 1:1:1 ratio. The trial will involve a 6-week oral administration of SIKD1977/placebo, and a 1-week follow-up period. The primary outcome will be the weekly average change in average daily pain score (ADPS) from baseline to the end of treatment. The secondary outcomes will include the weekly average changes in ADPS from baseline to week 2, 4, and 7, differences in Short-Form McGill Pain Questionnaire, Visual analogue scale, 5-level EuroQol-5 dimensions, Patient Global Impression of Change, and consumption of rescue drugs. All adverse events will be assessed during the trial. Conclusion: This study will provide evidence for the efficacy and safety of SIKD1977, and an effective dose for PHN. Trial Registration: This protocol has been registered in the Clinical Research Information Service with the identification code KCT0007939.

Systemic Analgesic Effects of Electroacupuncture in Healthy Individuals: Thermal Threshhold, Acupuncture Sensation Intensity and De-qi on Quantitative Sensory Test.

Background: Electroacupuncture (EA) has been known to exert analgesic effects according to several reports, but studies investigating the analgesic effect of EA using the quantitative sensory test (QST) are rare. Primary Study Objective: To investigate the analgesic effects of electroacupuncture through changes in thermal thresholds measured using the QST. Design: Pilot, randomized, single-blind, parallel design. Setting: The study was conducted at Dongguk University Bundang Oriental Hospital (DUBOH) in South Korea. Participants: We included 40 healthy participants age 20 to 40 years. Intervention: The EA group received EA for 30 minutes at 6 acupuncture points (LI4, PC6, LI10, LI11, ST36, and SP6) and the control group just rested. Outcome measures: The primary outcome measure was 4 thermal thresholds including warm detection (WDT), cold detection (CDT), hot pain (HPT), and cold pain (CPT) measured using QST at baseline and after 15, 30 and 60 minutes. The secondary outcomes were the intensity of acupuncture sensation (visual analogue scale [VAS]) and De-qi (Massachusetts General Hospital Acupuncture Sensation Scale [MASS]). Results: The EA group showed significant changes in HPT (P < .001) and CPT (P = .049) compared with the control group, whereas WDT and CDT did not significantly differ. Furthermore, the changes in thermal thresholds were more pronounced in the higher intensity acupuncture sensation group (VAS ≥40) than in the lower intensity group (VAS < 40), although not significantly. The high De-qi group presented greater changes in WDT, CDT, HPT and CPT than the low De-qi group, as measured using MASS. It was especially statistically significant at HPT a feeling of "heaviness" and "dull pain" and at CDT of "tingling." We observed no adverse events related to the study. Conclusion: The change in thermal pain thresholds effected by EA supports the analgesic effect of EA reported in previous studies. The underlying mechanisms need to be holistically considered, and further studies are needed for definitive evidence.

Extremity Injuries during Sporting Activities According to Life Course: Focusing on Fractures.

Background: The increased participation in sports has led to an increased number of sports-related injuries. We aimed to identify the incidence of sports-related injuries by life course and the risk factors for sports-related extremity fractures. Methods: We analyzed data of patients with sports-related extremity injuries from Emergency Department-based national injury surveillance systems, obtained from Jan 2013 to Dec 2016. A multiple logistic regression analysis was performed to identify risk factors of extremity fracture by life course after adjusting for sex, injury season, injury time, injury place, sports type, and mechanism of injury. Results: Overall, 23385 patients met our inclusion criteria. Soccer injuries were most common in the 5-14-year (32.4%), 15-24-year (43.0%), and 25-44-year groups (32.7%), and hiking injuries were most common in the 45-64-year (23.6%) and ≥65-year age groups (38.0%). The upper extremity injury and fracture rates were higher in the younger-age group; nevertheless, the injury and fracture rates of the lower extremities increased with increasing age. Moreover, the rate of hip and thigh injuries and fractures increased significantly in the ≥65-year age group. Conclusion: The incidence and severity of sports injuries are affected by player factors and the sports activity itself. The age of players is a major determinant that affects their medical and physiologic conditions and the sport of choice. The strategy for preventing sports injuries should be structured based on age.

Comparative effectiveness of different acupuncture therapies for neck pain.

BACKGROUND: Neck pain is a common musculoskeletal symptom that has negative effects on quality of life and work productivity. Acupuncture has been widely used for neck pain, and a number of randomized controlled trials (RCTs) and systematic reviews (SRs) have evaluated its effectiveness. However, previous studies have obtained inconsistent results regarding the effects of acupuncture for neck pain, and there is no SR for the comparative efficacy and safety of various types of acupuncture. Therefore, we herein conducted a SR and network meta-analysis to compare and rank different types of acupuncture with respect to their effectiveness in treating neck pain. METHODS: We searched 9 electronic databases for relevant RCTs published from their inception to July 1, 2021. Pairwise meta-analyses and network meta-analysis were performed with R software using the frequentist framework. Change of pain intensity was assessed as the primary outcome, and change of pain-related disability and efficacy rate were assessed as secondary outcomes. The Cochrane risk of bias tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) instrument were used to evaluate the quality of the included RCTs and the certainty of the evidence. RESULTS: A total of 65 RCTs involving 5266 participants and 9 interventions were included. Three network meta-analyses were constructed for the following: pain intensity (42 RCTs, 3158 participants), pain-related disability (21 RCTs, 1581 participants), and efficacy rate (40 RCTs, 3512 participants). The results indicated that fire acupuncture, electroacupuncture, and warm acupuncture were more effective than manual acupuncture in terms of pain intensity reduction and efficacy rate, and that electroacupuncture decreased pain-related disability more effectively than manual acupuncture. Fire acupuncture ranked first among the 9 interventions. The overall q of evidence was very low according to the GRADE assessment. The reported adverse events were not serious. CONCLUSION: Fire acupuncture, warm acupuncture, acupoint catgut embedding, and electroacupuncture ranked higher than other interventions (usual care, sham acupuncture, no treatment) in reducing the pain and disability index scores and the efficacy rate. However, the included trials were evaluated as being of low quality; thus, we recommend additional well-designed RCTs with larger sample sizes to confirm these findings. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021235274.

A survey of the clinical practice followed by Korean medicine doctors for scoliosis: Preliminary data for clinical practice guidelines.

Scoliosis is a spinal disease in which the Cobb angle is >10°. Scoliosis treatment can be surgical or conservative, and clinical practice guidelines (CPGs) for conservative treatments have been updated since 2006. There have been several articles regarding the efficacy and safety of Korean medicine (KM) in treating scoliosis, but there are no CPGs. Our study investigated the current clinical practice using a survey for the future establishment of KM-CPGs. The survey mainly comprised clinical practice status, diagnosis, treatment, progress and prognosis, and perception of KM on scoliosis, with reference to existing surveys of other musculoskeletal disorders and scoliosis-related articles. A web-based survey was conducted from February 16, 2021 to February 28, 2021. We found that 60% of KM doctors (KMDs) respondents treated patients with scoliosis, and they valued radiographical measurements and scoliosis-related factors in the diagnosis. KMDs used multiple KM treatments, including acupuncture, Chuna, cupping, pharmacopuncture, and herbal medicine, and they emphasized the importance of KM more in nonstructural scoliosis than in structural scoliosis. Although the perception of the prognosis of scoliosis was in agreement with that suggested by previous guidelines, KMDs showed outstanding focus on reduction of symptoms of scoliosis and improvement of quality of life. Despite some limitations, including low participation and the need for consulting other medical practitioners, our study may be helpful for the development of KM-CPGs because it is the first to analyze the perceptions of KMDs on scoliosis and to collect preliminary data that are of significance for preparing clinical guidelines.

Temperature Characteristics of Traditional Indirect Moxibustion and Electronic Moxibustion.

Background: Electronic moxibustion (EM) was developed to minimize the side effects of traditional moxibustion, such as burns, and to overcome therapeutic compliances such as smoke or smell. Objectives: To investigate distributions and thermal stimulation of EM at various depths using silicon phantom and to compare this methodology to traditional indirect moxibustion (TIM). Methods: A silicon phantom composed of polydimethylsiloxane was heated and immersed in a hot plate containing warm water to set the phantom's temperature to that of biological tissue. K-type thermocouples were inserted into the phantom at depths of 0, 2, 5, 7, and 10 mm to measure temperature changes with thermal stimulation of EM or TIM placed on top of the phantom. Results: At the surface of the phantom, the peak temperature after applying TIM (55.04 ± 0.92℃ [Δ23.79 ± 0.96℃]) was significantly higher than after EM (43.25 ± 1.95℃ [Δ13.00 ± 2.23℃]), with both interventions reaching the highest temperature after 2 minutes. The temperature increase for TIM was also statistically significant compared to EM when measured at a depth of 2 mm. For the experimental setting with TIM, after reaching peak surface temperature, a rapid decrease was observed at the surface and 2 mm while EM showed a much more gradual decline. There was no significant difference in temperature change between the groups at depths of 5, 7, and 10 mm. Conclusion: TIM resulted in a higher temperature rise compared to EM at the surface and at a 2 mm depth reaching over 50℃, which creates risk of burns. Thermal stimulation with EM had a lower risk of burns with temperature increment not being statistically different from TIM below the depth of 5 mm.

Effectiveness and safety of electric heating moxibustion for perennial allergic rhinitis: A pilot, randomized, assessor-blind trial.

BACKGROUND: The prevalence of allergic rhinitis (AR), an inflammatory disease, is gradually increasing. Studies have reported that moxibustion is effective for treating AR. Electric heating moxibustion (EM) was developed to offer adaptable heat stimulation without the generation of smoke. OBJECTIVES: The objective of this study was to examine the possibility of EM in treating perennial allergic rhinitis (PAR) and to assess the feasibility of using this technique on a larger scale by comparing EM with acupuncture (AC). DESIGN: A randomized pilot study was conducted on 40 patients with PAR. Patients were randomly assigned to one of two treatment groups: EM or AC. The primary outcome measure was the change in the total nasal symptom score (TNSS) between before and after treatment. The secondary outcome measures were the changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ), nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total serum immunoglobulin E (IgE), eosinophil count, and adverse effects (AEs). RESULTS: The results showed a statistically significant improvement in mean TNSS and RQLQ scores in both groups (p < 0.05), but no significant difference between the two groups. However, mean changes in itching and sneezing TNSS were significantly higher in the AC group. There was no significant difference in total serum IgE or eosinophil count before versus after treatment, nor was there any significant difference of three pattern subgroups between the two groups in the mean TNSS change. While the AC group reported two treatment-related AEs, there were no treatment-related AEs in the EM group. CONCLUSION: This trial provides evidence that EM isa safe alternative treatment for patients with PAR. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03342105. Registered on 14 November 2017.

Thermal Properties of Warm- versus Heated-Needle Acupuncture.

Background: Warm-needle acupuncture (WA) and fire-needle acupuncture are treatment techniques that use the combination of acupuncture and thermal stimulation. In clinical practice, a new method of fire-needle acupuncture called "heated-needle acupuncture (HA)" has been proposed, wherein the needle is directly heated after insertion. WA and HA share similarities in their methods, and no previous study has sought to assess whether their thermal outcomes are also similar. Methods: We controlled environmental variables and measured the maximum temperatures and temperature changes of a silicon phantom in which K-type thermocouples were embedded at depths of 0, 2, 5, 7, and 10 mm. WA and HA were also performed with acupuncture needles of various thicknesses (0.30 × 40 mm, 0.40 × 40 mm, and 0.50 × 40 mm). Results: Different time-dependent temperature distributions were observed between the two acupuncture methods: HA yielded a higher maximum temperature and temperature change on the surface, whereas WA yielded higher temperatures at the other tested depths. The thermal patterns were similar among the needles of different thicknesses for each method, with the following exception: while the temperature change and maximum temperature did not differ significantly by needle thickness for WA, these parameters increased significantly with needle thickness for HA. Conclusion: The two acupuncture procedures yielded different thermal patterns in a controlled environment. Further studies are necessary to reflect the effect of external environment variables occurring in reality.

The effectiveness of different acupuncture therapies for neck pain: A protocol for systematic review and/or network meta-analysis.

BACKGROUND: Neck pain is common musculoskeletal disorders in adult population. Acupuncture treatment has been widely used for treating neck pain. Nevertheless, previous systematic reviews (SRs) on acupuncture for neck pain remain controversial, and there is no SR for the comparative efficacy and safety of various types of acupuncture. Therefore, this study aims to evaluate and rank the effectiveness and safety of different types of acupuncture for neck pain by SR and network meta-analysis. METHODS: Nine databases will be searched, including Ovid-MEDLINE, EMBASE, Cochrane library, China National Knowledge Infrastructure (CNKI), KoreaMed, Korean medical database (KMBASE), Korean Studies Information Service System (KISS), ScienceON, and Oriental Medicine Advanced Searching Integrated System (OASIS) from their inception to July 2021. The primary outcome is the change of pain intensity. A frequentist network meta-analysis will be performed to compare all relative outcomes of different acupuncture methods, using R software. The quality of included randomized controlled trials will be assessed by Cochrane Collaboration "risk of bias" tools and the evidence will be evaluated by the Grading of Recommendations Assessment, Development and Evaluation instrument. RESULTS: The final findings of this network meta-analysis will be published in a recognized journal. CONCLUSIONS: Our study will evaluate and compare the effectiveness of various types of acupuncture for neck pain and provide clinicians with best option for what types of acupuncture treatments are effective. TRIAL REGISTRATION NUMBER: INPLASY202120041.

The effectiveness and safety of acupuncture for scoliosis: A protocol for systematic review and/or meta-analysis.

BACKGROUND: Scoliosis is a disease that affects all age groups and alters the three-dimensional deviation of the spinal axis. It is diagnosed when Cobb angle presents over 10 degrees and the reasons include aging, traumatic injuries, unknown origin, and disorders of congenital, neurological, musculoskeletal, and connective tissue. Scoliosis treatments are divided into surgical and conservative options. Surgery can correct the curved spine but has associated risks and economic burden. Conservative treatments, particularly bracing, prevent the progression of scoliosis, but still remains potential ingredient of curvation and patients poor compliance. Recent studies reported that various types of acupuncture can improve the curvation and the associated pain. However, there has been no systematic review on this issue. Therefore, this study will review the effectiveness and safety of acupuncture on scoliosis. METHODS: Searching randomized controlled trials about the use of acupuncture for scoliosis will be performed using multiple electronic databases, manual search, and contact to authors e-mail if needed. We will select studies by the pre-defined criteria and summarize the data on study participants, interventions, control groups, outcome measurement, adverse events, and risk of bias. The primary outcome will be the Cobb angle, which is objective, and the secondary outcomes are associated with patient-centered indices (pain, functional status, and quality of life), which are subjective and adverse events. We will use Review Manager software (Version 5.3; Copenhagen; The Nordic Cochrane Center, The Cochrane Collaboration, 2014) to perform a meta-analysis and Cochrane Collaboration "risk of bias" tools to assess the risk of bias. RESULTS: Our study will investigate the clinical evidence on the effectiveness and safety of acupuncture on scoliosis. CONCLUSION: Our study will be informative to scoliosis patients, clinicians, policy makers, and researchers working with conservative management for scoliosis.