Substantiating the Therapeutic Effects of Simultaneous Heat Massage Combined with Conventional Physical Therapy for Treatment of Lower Back Pain: A Randomized Controlled Feasibility Trial.

BACKGROUND: There are various therapeutic options for the conservative management of lower back pain (LBP). A combination of two or more treatment options may be more effective in the clinical management of non-specific LBP. In this study, we compared the effects of simultaneous heat massage with conventional physical therapy in patients with subacute LBP. METHODS: A single-center randomized controlled trial in which 40 participants with LBP were allocated to one of two groups: a heat massage group (HMG) and physical therapy group (PTG). The HMG received simultaneous heat massage therapy using a mechanical device (CGM MB-1401, Ceragem, Republic of Korea). The PTG received conventional physical therapy. Both groups received 40 min of therapy once daily, five times a week, for a total of four weeks. Changes in serum cortisol, epinephrine (EP), and norepinephrine (NE) were assessed. The outcomes were measured using the pain numeric rating scale (PNRS), the Oswestry disability index (ODI), the Roland-Morris disability questionnaire (RMDQ), the short-form McGill pain questionnaire (SF-MPQ), the multidimensional fatigue inventory (MFI-20), the Beck depression inventory (BDI), surface EMG (sEMG), and sympathetic skin response (SSR) at baseline (PRE), at 2 (2 W) and 4 weeks (4 W) following the intervention. RESULTS: The serum EP and NE levels in the HMG decreased after treatment. The PNRS, ODI, RMDQ, and SF-MPQ scores improved without significance in both groups. The BDI score showed improvement in the HMG before the PTG. The MFI-20 score improved in both groups, but the results were better in the HMG than in the PTG at 4 W. All the activities of sEMG were significantly decreased in both groups. However, the improvement of the %MVIC in the HMG was better than that in the PTG at 4 W. The SSR latency on sEMG decreased while the amplitude increased in the HMG at 2 W and 4 W, respectively. CONCLUSIONS: Following 4 weeks of combined therapies, heat massage was not superior to conventional physical therapy alone. Both treatments were shown to be effective in improving LBP and pain-related disability. However, heat massage was shown to have a better effect on the control of autonomic nerve function and underlying moods.

Effects of Personal Low-Frequency Stimulation Device on Myalgia: A Randomized Controlled Trial.

Electrotherapy is commonly used for myalgia alleviation. Low-frequency stimulation (LFS) is primarily used for controlling acute and chronic pain and is a non-invasive therapy that can be easily performed with electric stimulation applied on the skin. However, little evidence exists regarding the pain alleviation effects of personal low-frequency stimulation device for home use. Moreover, no studies have compared myalgia alleviation effects between personal low-frequency stimulation (PLS) and physical therapy (PT), which are most commonly used for patients with myalgia in hospitals and clinics. Therefore, we aimed to investigate the pain alleviation effects of PLS in patients with myalgia and compare these effects with those of conventional PT (transcutaneous electrical nerve stimulation + ultrasound). In total, 39 patients with myalgia in the neck, shoulder, back, and waist areas were randomly assigned to the personal low-frequency stimulation group (PLSG: n = 20) and physical therapy group (PTG: n = 19). Both groups were treated for 3 weeks (20 min per session and 5 sessions per week). Patients were assessed for pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ) before and after the intervention period. Our results showed that PLSG showed a tendency of muscle relaxation with a significant decrease in sEMG in the neck (p = 0.0425), shoulder (p = 0.0425), and back (p = 0.0046) areas compared to the control group. However, there was no significant difference in waist area. Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG (p = 0.0098), and PLSG (p = 0.0304) groups, but there was no significance difference between the groups. With respect to SF-MPQ, the PLSG showed greater pain alleviation (5.23 ± 0.25) effects than the PTG (6.23 ± 0.25). Accordingly, our results suggest that PLS treatment using a home device might offer positive assistance in pain alleviation for patients with myalgia that is as equally effective as conventional PT treatment. However, further detailed studies are required considering larger samples to fully claim the effectiveness of this device.

Mechanical Changes of the Lumbar Intervertebral Space and Lordotic Angle Caused by Posterior-to-Anterior Traction Using a Spinal Thermal Massage Device in Healthy People.

BACKGROUND: The axial (horizontal) traction approach has been traditionally used for treatment of low back pain-related spinal disorders such as nuclear protrusion, primary posterolateral root pain, and lower thoracic disc herniation; however, it is known to have some technical limitations due to reductions of the spinal curve. Lumbar lordosis plays a pivotal function in maintaining sagittal balance. Recently, vertical traction and combination traction have been attracting attention due to improving therapeutic outcomes, although evidence of their clinical application is rare; therefore, this study was conducted to investigate the mechanical changes of lumbar intervertebral space, lordotic angle, and the central spinal canal area through vertical traction treatment using a spinal massage device in healthy participants. METHODS: In total, 10 healthy subjects with no musculoskeletal disorders and no physical activity restrictions participated. The participants lay on the experimental device (CGM MB-1901) in supine extended posture and vertical traction force was applied in a posterior-to-anterior direction on the L3-4 and L4-5 lumbar sections at level 1 (baseline) and level 9 (traction mode). Magnetic resonance (MR) images were recorded directly under traction mode using the MRI scanner. The height values of the intervertebral space (anterior, center, and posterior parts) and lordosis angle of the L3-4 and L4-5 sections were measured using Image J software and the central spinal canal area (L4-5) was observed through superimposition method using the MR images. All measurement and image analyses were conducted by 2 experienced radiologists under a single-blinded method. RESULTS: The average height values of the intervertebral space under traction mode were significantly increased in both L3-4 and L4-5 sections compared to baseline, particularly in the anterior and central parts but not in the posterior part. Cobb's angle also showed significant increases in both L3-4 and L4-5 sections compared to baseline (p < 0.001). The central spinal canal area showed a slightly expanded feature in traction mode. CONCLUSIONS: In this pilot experiment, posterior-to-anterior vertical traction on L3-4 and L4-5 sections using a spinal massage device caused positive and significant changes based on increases of the intervertebral space height, lumbar lordosis angle, and central spinal canal area compared to the baseline condition. Our results are expected to be useful as underlying data for the clinical application of vertical traction.

Nickelocene as an Air- and Moisture-Tolerant Precatalyst in the Regioselective Synthesis of Multisubstituted Pyridines.

Ni(COD)2-catalyzed cycloaddition reactions to access pyridines have been extensively studied. However, this catalyst typically requires drying procedures and inert-atmosphere techniques for the reactions. Herein, we report operationally simple nickel(0) catalysis to access substituted pyridines from various nitriles and 1,6-diynes without the aid of air-free techniques. The Ni-Xantphos-based catalytic manifold is tolerant to air, moisture, and heat while promoting the [2 + 2 + 2] cycloaddition reactions with high reaction yields and broad substrate scope. In addition, we disclose that not only the steric effect but also the frontier molecular orbital interactions can play a critical role in determining the regiochemical outcome of nickel-catalyzed [2 + 2 + 2] cycloaddition for the synthesis of substituted pyridines.

Use of a Spinal Thermal Massage Device for Anti-oxidative Function and Pain Alleviation.

Background: Elderly people are vulnerable to a variety of diseases, including chronic pain, which reduces their levels of physical fitness. Thermal massage has been shown to relieve pain and activate antioxidant enzymes. The objective of this study was to determine whether thermal massaging of the spinal column can reduce muscle pain and induce antioxidant function. Methods: This study included participants aged ≥60 years with lower back pain. The participants were assigned to either an experimental group who received spinal column thermal massage and standard rehabilitative treatment or a control group who received standard rehabilitative treatment only. Data from a total of 116 participants (61 and 55 in the control and experimental groups, respectively) were used for analysis. Participants were assessed before treatment and at 4 (POST1) and 8 weeks (POST2) post-treatment, using a pain numeric rating scale (PNRS) and the Roland and Morris Disability Questionnaire (RMDQ), and by measuring the serum levels of superoxide dismutase (SOD), serum glutathione-peroxidase (GPx), and serum catalase (CAT). Results: The extent of pain reduction, as measured by the PNRS, was greater in the experimental group. The RMDQ score in the control group decreased at POST1, but the decrease was not maintained at POST2, whereas the decrease in POST1 in the experimental group continued until POST2. SOD concentrations were significantly higher in the experimental group at POST1 and POST2, and GPx levels were significantly higher in the experimental group at POST2; however, there were no changes in CAT concentrations. Incidentally, there was a significant correlation between antioxidant activity and pain perception in the experimental group. Conclusions: The study findings suggest that spinal column thermal massage reduces pain more effectively, improves self-reported levels of disability, and increases the antioxidant enzyme levels. Thermal massage may, therefore, be useful in the prevention and treatment of diseases associated with oxidation.

Redox-Active Functional Electrolyte for High-Performance Seawater Batteries.

Rechargeable seawater batteries have gained recognition as key sustainable electrochemical systems by employing the near-infinite and eco-friendly catholyte seawater. However, their practical applications have been limited owing to the low chemical and electrochemical stability of the anode component. Herein, a stability-secured approach was developed by using sodium-biphenyl-dimethoxyethane solution as a redox-active functional anolyte for high-performance seawater batteries. This anolyte system shows high electrochemical stability, superior cycle performance, and cost-effectiveness over conventional electrolyte systems.

Using non-vitamin K oral anticoagulants in specific patient populations: a study of Korean cases.

Non-vitamin K oral anticoagulants (NOACs) are increasingly used as alternatives to conventional therapies and have considerable accumulated real-world clinical data in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). However, it is not easy to make a complete changeover to NOACs in real-world clinical practice because NOACs still have challenges in specific patient populations (eg, Asian patients, NVAF patients presenting with acute coronary syndrome [ACS], dialysis patients with NVAF, patients with cancer-associated VTE, etc.). Clinical data on the optimal dose of NOACs in Asian patients with NVAF are not sufficient. The intensity of NOAC and antiplatelet treatment and the duration of antiplatelet treatment should be adjusted according to the bleeding and thrombotic risk profiles of the individual NVAF patient presenting with ACS. Increased bleeding risk and unclear efficacy of NOACs in dialysis patients with NVAF should be considered when making decisions on whether to give NOACs for these patients. If dialysis patients with NVAF require anticoagulant for stroke prevention, then apixaban could be considered while awaiting more clinical efficacy and safety data. Additional studies are needed to determine the utility of continuing treatment with reduced-dose NOACs for long-term therapy after VTE. We have enough experiences in using NOACs in cancer patients showing the benefit of antithrombotic treatment counterbalanced the bleeding risk; however, some challenges of cancer-associated VTE management exist due to differences in cancer types or chemotherapy regimens and comorbidities. Different dosing regimens among NOACs may impact on medication adherence; thus, individual patient preference should be considered in choosing a particular NOAC. A significant proportion of patients remain on warfarin because of the high price of NOACs and variability in reimbursement coverage. To compensate clinical-evidence and achieve optimal use of NOACs, we should pay attention to the outcomes of ongoing studies and evaluate more real-world data.

How Does "Regulatory Practice" Create Discrepancies in Drug Label Information Between Asian and Western Countries? Different Label Information for Direct Oral Anticoagulants Approved in the United States, Europe, Korea, and Japan.

Globalization of the pharmaceutical industry has continued over the past few decades, and various regulatory authorities have put considerable effort into harmonizing and standardizing drug regulations. However, the regulatory practices of each regulatory authority, in addition to local differences in ethnic, social, and cultural backgrounds, create discrepancies in risk/benefit assessments, regulatory decisions, and drug label information in various countries. This study examines discrepancies in the label information for direct oral anticoagulants approved in the US, Europe, Korea, and Japan and reviews the causes of those discrepancies, focusing on regulatory practices. Although the label information for each direct oral anticoagulant in all 4 regions was supported by the same global, pivotal clinical data, it differed depending on regulatory authorities' judgments about the risk/benefit balance, which were based on their own requirements, regulations, perspectives on making regulatory decisions, and regulatory approval experiences, in addition to their review of the scientific data. In particular, the Korean Ministry of Food and Drug Safety and Japanese Pharmaceuticals and Medical Devices Agency have taken a comparatively conservative stance, with more emphasis on safety than on efficacy compared with regulatory authorities in western countries, because of the double threshold in their regulatory practice. Our findings suggest that drug label information in various regions will not be equal as long as differences in regulatory practice and non-regulatory factors exist among regulatory authorities. Also, those differences should be considered in order to streamline global drug discovery, development, and approval.

Real-Time Light-Guided Vocal Fold Injection: Ex Vivo Feasibility Study in a Canine Model.

OBJECTIVE: The transcricothyroid (CT) membrane approach is a good option for office-based vocal fold injection (VFI). However, because the needle tip is invisible during injection using the CT approach, precise localization requires a high level of experience, and mastering this approach involves a steep learning curve. To overcome current limitations, we conceptualized a novel technique: real-time light-guided VFI (RL-VFI), which enables simultaneous VFI under direct visualization of the lighted needle tip. Herein, we aimed to verify the feasibility of RL-VFI in cadaveric canine model, simulating the setting of office-based VFI, as well as to explore its clinical usefulness. STUDY DESIGN: Animal study. METHODS: A customized prototype device was developed. It consisted of three parts: light source, controller, and injector. Light source comprised laser diodes of two wavelengths (635 nanometers [nm], red; 532 nm, green). Four types of injector were developed using 40-mm needles of 23- and 25-gauge and optic fibers of 50 and 100 µm. ex vivo canine larynx was prepared for the experiment. Flexible laryngoscopy system was used to examine canine vocal folds. RESULTS: Various routes from three insertion points (3 mm, 10 mm, and 17 mm from the midline) were validated using the device. Regardless of the injection routes, the location of the needle tip was accurately indicated by light. RL-VFI was feasible under light guidance without difficulties. Moreover, precise and simultaneous re-injection could be performed at the intended point using the device. CONCLUSION: We introduced RL-VFI using our customized prototype device in an ex vivo canine larynx, simulating the setting of office-based VFI. Clinical application of RL-VFI will improve safety and precision of CT approach, as well as expand its applications in laryngology. LEVEL OF EVIDENCE: NA. Laryngoscope, 129:935-942, 2019.

Septochoanal Polyp with Metaplastic Ossification Mimicking Sinonasal Tumor: A Case Report.

Choanal polyps are a form of nasal polyps that grow toward the choana with a single stalk. Septochoanal polyp is a rare entity that originates from the mucosa of the nasal septum with choanal extension. The most common site of its origin is mainly the superior aspect of the posterior portion of the nasal septum. However, metaplastic ossification is a rare event in nasal polyp and to the best of our knowledge, septochoanal polyp with metaplastic ossification has not been reported in the literature. Herein, we report a case of huge septochoanal polyp with metaplastic ossification obstructing both the nasal cavity and nasopharynx, which was successfully removed via transnasal endoscopic approach.

Potential therapeutic mechanism of extremely low-frequency high-voltage electric fields in cells.

The aim of this survey was to provide background theory based on previous research to elucidate the potential pathway by which medical devices using extremely low-frequency high-voltage electric fields (ELF-HVEF) exert therapeutic effects on the human body, and to increase understanding of the AC high-voltage electrotherapeutic apparatus for consumers and suppliers of the relevant devices. Our review revealed that an ELF field as weak as 1-10 µ V/m can induce diverse alterations of membrane proteins such as transporters and channel proteins, including changes in Ca + + binding to a specific site of the cell surface, changes in ion (e.g., Ca + + ) influx or efflux, and alterations in the ligand-receptor interaction. These alterations then induce cytoplasmic responses within cells (Ca + + , cAMP, kinases, etc.) that can have impacts on cell growth, differentiation, and other functional properties by promoting the synthesis of macromolecules. Moreover, increased cytoplasmic Ca + + involves calmodulin-dependent signaling and consequent Ca + + /calmodulin-dependent stimulation of nitric oxide synthesis. This event in turn induces the nitric oxide-cGMP-protein kinase G pathway, which may be an essential factor in the observed physiological and therapeutic responses.

Is 1/f sound more effective than simple resting in reducing stress response?

BACKGROUND: It has been previously demonstrated that listening to 1/f sound effectively reduces stress. However, these findings have been inconsistent and further study on the relationship between 1/f sound and the stress response is consequently necessary. OBJECTIVE: The present study examined whether sound with 1/f properties (1/f sound) affects stress-induced electroencephalogram (EEG) changes. METHODS: Twenty-six subjects who voluntarily participated in the study were randomly assigned to the experimental or control group. Data from four participants were excluded because of EEG artifacts. A mental arithmetic task was used as a stressor. Participants in the experiment group listened to 1/f sound for 5 minutes and 33 seconds, while participants in the control group sat quietly for the same duration. EEG recordings were obtained at various points throughout the experiment. After the experiment, participants completed a questionnaire on the affective impact of the 1/f sound. RESULTS: The results indicated that the mental arithmetic task effectively induced a stress response measurable by EEG. Relative theta power at all electrode sites was significantly lower than baseline in both the control and experimental group. Relative alpha power was significantly lower, and relative beta power was significantly higher in the T3 and T4 areas. Secondly, 1/f sound and simple resting affected task-associated EEG changes in a similar manner. Finally, participants reported in the questionnaire that they experienced a positive feeling in response to the 1/f sound. CONCLUSIONS: Our results suggest that a commercialized 1/f sound product is not more effective than simple resting in alleviating the physiological stress response.