Potential use of polydimethylsiloxane phantom in acupuncture manipulation practice.

Objectives: Sufficient trials of acupuncture manipulations should be practiced to obtain proficiency. However, there is not an adequate quantitative methodology for selecting a tissue-mimicking phantom that effectively reproduces the mechanical behavior that occurs during acupuncture. The objective of this study was to determine the proper mixing ratio of polydimethylsiloxane (PDMS) to obtain tissue phantom that is the most similar to porcine phantoms. Design: An automatic needle manipulator equipped with a six-degrees-of-freedom force/torque sensor was installed to monitor the interaction force that occurred when the acupuncture needle performed lifting-thrusting and twirling manipulations. Four types of PDMS phantoms, composed of two silicone elastomers with different hardener ratios, were studied alongside four control groups consisting of different porcine sites. A Visual Analog Scale was used to quantify the similarity of the PDMS phantoms to the controls by 11 Korean medical doctors. Results: Using the lifting-thrusting method, PDMS D (mixing ratio of 1:4.5) and control 2 (porcine blade shoulder) revealed no significant difference in the dynamic friction coefficients or maximum and minimum friction force values (P < 0.001). Using the twirling method, PDMS D showed no significant difference from all controls in the viscosity coefficient or maximum and minimum torque values (P ≤ 0.001). By practitioners, PDMS D showed the greatest score. Conclusion: PDMS D delivered a haptic sensation that is most similar to that of biological tissues in the case of acu-needle lifting-thrusting and twirling methods. This finding guides the preparation of tissue phantoms for acu-needle studies and acupuncture training.

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.

Effectiveness and safety of electrical moxibustion for knee osteoarthritis: A multicenter, randomized, assessor-blinded, parallel-group clinical trial.

BACKGROUND: The prevalence of knee osteoarthritis (KOA) is increasing, and it has emerged as a major health issue. Studies have been reported that moxibustion is effective for treating KOA, but conventional moxibustion is difficult to control the intensity of stimulation and causes smoke, harmful gases, or odors. An electrical moxibustion (EM) device was developed to solve these problems, so we conducted this study to evaluate the effectiveness and safety of EM as a treatment for KOA. METHODS: This is a multicenter, randomized, assessor-blinded, parallel-group clinical trial. Participants with KOA were randomly allocated into EM, traditional indirect moxibustion (TIM), or usual care groups. The moxibustion groups were received 12 sessions of moxibustion treatment at six acupuncture points (ST36, ST35, ST34, SP9, EX-LE4, SP10) over a period of 6 weeks. The usual care group was received usual treatment and self-care. The primary outcome was the degree of pain measured by numerical rating scale (NRS). The second outcomes were measured using visual analog scale, Korean version of the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life five dimension five level scale, and warm sense threshold and heat pain threshold. For safety assessment, laboratory test and adverse events (AEs) were recorded. RESULTS: A total of 138 participants were assigned. While there was no significant NRS change in the usual care, EM and TIM showed significant decrease after treatment. Compared to the usual care, the mean change of NRS in the EM and TIM was significantly different, but there was no significance between two groups. Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups. Regarding safety assessment, while usual care showed significant safety among three groups, EM showed seven treatment-related AEs by four participants compared TIM's 10 events by 10 participants. In addition, there was no blister caused by burns in the EM, which occurred four cases in the TIM. CONCLUSION: This study shows that EM is effective to improve the pain and function by KOA with a certain level of safety.

Efficacy of Korean red ginseng (Panax ginseng) for middle-aged and moderate level of chronic fatigue patients: A randomized, double-blind, placebo-controlled trial.

OBJECTIVES: Chronic fatigue (CF) is unexplained fatigue lasting more than 6 months. Korean red ginseng (KRG) is known to have higher anti-fatigue substance than white ginseng. However, its efficacy and safety for CF is unknown. The purpose of this study was to investigate the effect of KRG on CF by various measurements and objective indicators. DESIGN: A randomized, double-blind, clinical trial was conducted on 50 patients with CF. INTERVENTION: Participants were allocated to KRG or placebo group (1:1 ratio) and visited hospital every 2 weeks during taking 3 g KRG or placebo for 6 weeks and followed up 4 weeks after the treatment. MAIN OUTCOME MEASURES: The primary outcome measurement was fatigue VAS. Secondary outcome measurements included FSS, CFSQ, SRI, scales of various fields (Depression: BDI; Sleep: ISI; Quality of life: EQ-5D 5 L), biochemical test (Antioxidants: d-ROMs, TBARS, BAP, and SOD; Cortisol concentration: salivary cortisol), blinding assessment, and adverse events. RESULTS: The fatigue VAS declined significantly in each group, but there were no significant differences between the groups. The 2 groups also had no significant differences in the secondary outcome measurements and there were no adverse events. Sub-group analysis indicated that patients with initial fatigue VAS below 80 mm and older than 50 years had significantly greater reductions in the fatigue VAS if they used KRG rather than placebo. CONCLUSIONS: By our study, KRG did not show absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for middle-aged individuals with moderate fatigue.

Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial.

BACKGROUND: Allergic rhinitis (AR) is an IgE-mediated disease that adversely affects quality of life. Many studies report that moxibustion is an effective treatment for perennial allergic rhinitis (PAR). However, it is difficult to perform moxibustion on the face because of possible burning of the skin and the noxious effects of smoke. Electric heating moxibustion does not have these limitations. The purpose of this clinical trial is to assess the possibility of treating PAR with electric heating moxibustion and to assess the feasibility of conducting a clinical test on a larger scale. METHODS: This is a randomized, open-label, assessor-blind, parallel-design pilot clinical study. We will recruit 40 eligible participants and randomly allocate them into an electric heating moxibustion group or an acupuncture group at a 1:1 ratio. Patients in both groups will receive eight treatments over 4 weeks, and the final follow-up will be 4 weeks after the last treatment. Eleven acupuncture points will be used for patients in both groups (EX-HN3 and bilateral EX-HN-8, LI20, LI4, GB20, and ST36). The primary outcome measure is change in the Total Nasal Symptom Score, and the secondary outcome measures are changes in the Rhinoconjunctivitis Quality of Life Questionnaire, nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total IgE, eosinophil count, and adverse effects. DISCUSSION: This clinical trial will examine the effect of electric heating moxibustion on PAR. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03342105 . Registered on 14 November 2017.

Can a Traditional Korean Manual Therapy Be a Complementary and Alternative Strategy for Cervicogenic Dizziness? A Study Protocol for a Randomized Controlled Trial.

Cervicogenic dizziness is dizziness triggered by movement or positioning of the cervical spine and is often accompanied by neck pain or stiffness. This is a prospective, pragmatic, assessor-blind, randomized controlled trial aimed at testing the efficacy and safety of adjuvant Chuna Manual Therapy (CMT) in patients with cervicogenic dizziness under usual care treatments. Fifty patients with cervicogenic dizziness will be randomly allocated to CMT or usual care (UC) groups in a 1 : 1 ratio. Extensive screening procedures, including examinations for central nervous system problems and nystagmus, will be applied to exclude other dizziness-inducing disorders. The eligible participants will receive 12 sessions of CMT plus UC or only UC over 6 weeks. CMT includes mandatory and discretionary techniques, whereas UC includes electrotherapy, thermotherapy, and patient education. The efficacy will be evaluated primarily as Dizziness Handicap Inventory score. The severity and frequency of dizziness, the level of neck pain or stiffness, and the cervical range of motion will also be evaluated. Safety will be assessed by adverse events. The data will be statistically analyzed at p < 0.05. Trial Registration. This trial was registered with Clinical Research Information Service (CRIS) in Korea, KCT0002565, on 29 November 2017, https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=9610<ype=&rtype=.

Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial.

BACKGROUND: Previous studies have shown that electroacupuncture (EA) reduces the severity of acute pancreatitis. However, the effect of EA for pain relief in patients with acute pancreatitis has not been evaluated yet. The purpose of this study was to prove the efficacy of EA for pain relief in patients with acute pancreatitis compared with conventional treatment. METHODS: This study is a randomized, controlled, three-arm, parallel-group, multi-center trial. Patients diagnosed with acute pancreatitis are enrolled and randomly assigned to EA 1, EA 2, or a control group in a 1:1:1 ratio. All the enrolled patients basically receive the conventional standard-of-care therapy for acute pancreatitis. Local EA is given in group EA 1, while local with additional distal EA is given in group EA 2. Local EA includes two acupoints, Zhong Wan (CV12) and Shang Wan (CV13), located in the abdomen, while distal EA includes 12 peripheral acupoints, Zhong Wan (CV12), Shang Wan (CV13), He Gu (LI4), Nei Guan (PC6), San Yin Jiao (SP6), Xuan Zhong (GB39), Zu San Li (ST36), and Shang Ju Xu (ST37). The patients randomized to the EA 1 and EA 2 groups undergo one session of EA daily from day 1 until day 4, or until pain resolves. The primary endpoint is the Visual Analog Scale (VAS) change for pain on day 5. Secondary endpoints include daily VAS, requirement of analgesics, changes of inflammatory markers, time to pain disappearance, and hospital days. DISCUSSION: The results of this trial are expected to prove the efficacy of EA for pain relief in patients with acute pancreatitis. Based upon the results, EA would be applied to a variety of clinical practices for reducing pain. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov, ID: NCT03173222 . Registered on 1 August 2017.

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.

Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial.

BACKGROUND: Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS: This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of "ashi", if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION: This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03287570 . Registered on 19 September 2017.

Single-dose Toxicity of Guseonwangdo-go Glucose 5% Intravenous Injection in a Rat Model.

OBJECTIVES: The purpose of this study was to examine the single-dose intravenous toxicity of Guseonwangdo-go glucose 5% pharmacopuncture (GWG5). METHODS: Forty Sprague-Dawley rats were divided into four groups of five males and five females per group: an intravenous (IV) injection of 1.0 mL of normal saline solution per animal was administered to the control group; IV injections of 0.1, 0.5, and 1.0 mL of GWG5 per animal were administered to the experimental groups (G: 0.1, G: 0.5, and G: 1.0). Observation of clinical signs and body weight measurements were carried out for 14 days following the injections. At the end of the observation period, hematological, biochemical, and histopathological tests, as well as necropsy examinations, were performed on the injected parts. RESULTS: No mortalities or adverse clinical signs were observed in any of the groups. The body weights of all groups continuously increased. In the hematological and the biochemical tests, females in G-0.1 had minimal changes, but those changes were not dose dependent. On necropsy examination, no abnormalities were observed. In the histopathological test, focal inflammatory cell infiltrations were observed in two female rats, one in the control group and one in G-1.0. Also, one female rat in the control group had an epidermis crust. These changes were concluded to have been caused by the insertion of the needle into a vein. CONCLUSION: The above findings suggest that the lethal dose of GWG5 administered via IV injection is more than 1.0 mL per animal in both male and female rats. Further studies are needed to establish more detailed evidence of its toxicity.

Efficacy of pharmacopuncture using root bark of Ulmus davidiana Planch in patients with knee osteoarthritis: a double-blind randomized controlled trial.

The aim of this study was to determine whether pharmacopuncture is a clinically effective and safe method for the treatment of knee osteoarthritis. Patients were recruited between August 2008 and December 2008 at the Ilsan Hospital associated with Dongguk University. Patients were randomly assigned to one of the two groups. The experimental group (n = 30) received pharmacopuncture using root bark of Ulmus davidiana Planch (UDP) twice a week for 6 weeks; the control group (n = 30) received normal saline injections. Fifty-three patients completed the trial. After the seventh treatment, we found that UDP pharmacopuncture was more effective in pain improvement using a Visual Analog Scale than was normal saline injection. However, the two interventions were not significantly different as measured by the Western Ontario and McMaster Universities pain score and total pain scores, 36-Item Short Form Health Survey, and Korean Health Assessment Questionnaire. No subject showed any serious adverse effects. The effects of pharmacopuncture treatment were a combination of placebo, needle stimulation, mechanical effect of the solution, and a chemical effect of UDP. However, normal saline used as the control intervention displayed the first three effects, and thus its effect was not inert. This may have influenced the results of the trial, which was statistically insignificant between the two groups, except following the seventh treatment session.