Jae-Hong Kim

Scalp acupuncture and electromagnetic convergence stimulation for patients with cerebral infarction: study protocol for a randomized controlled trial

BackgroundScalp acupuncture (SA) and repetitive transcranial magnetic stimulation (rTMS) are effective for treating cerebral infarction. This study aims to examine the efficacy and safety of SA and electromagnetic convergence stimulation (SAEM-CS), which was developed through collaboration between conventional medical physicians and doctors who practice traditional Korean medicine. SAEM-CS was designed to improve function in patients with cerebral infarction, compared to the improvement after conventional stroke rehabilitation, SA, and rTMS therapeutic approaches.Methods/designThis study is a prospective, outcome assessor-blinded, randomized controlled clinical trial with a 1:1:1:1 allocation ratio. Participants with motion or sensory disabilities caused by a first-time cerebral infarction (nu2009=u200960) that had occurred within 1xa0month of the study onset will be randomly assigned to control, SA, rTMS, or SAEM-CS groups. All groups will receive two sessions of conventional rehabilitation treatment per day. The SA group will receive SA on the upper limb area of MS6 and MS7 (at the lesional hemisphere) for 20xa0min, the rTMS group will receive low-frequency rTMS (LF-rTMS) treatment on the hot spot of the M1 region (motor cortex at the contralesional hemisphere) for 20xa0min, and the SAEM-CS group will receive LF-rTMS over the contralesional M1 region hot spot while receiving simultaneous SA stimulation on the lesional upper limb area of MS6 and MS7 for 20xa0min. SA, rTMS, and SAEM-CS treatments will be conducted once/day, 5xa0days/week (excluding Saturdays and Sundays) for 3xa0weeks, for a total of 15 sessions. The primary outcome will be evaluated using the Fugl‐Meyer Assessment, while other scales assessing cognitive function, activities of daily living, walking, quality of life, and stroke severity are considered secondary outcome measures. Outcome measurements will be conducted at baseline (before intervention), 3xa0weeks after the first intervention (end of intervention), and 4xa0weeks after intervention completion.DiscussionThis study aims to explore the efficacy and safety of SAEM-CS on cerebral infarction. Collaborative research combined traditional Korean and conventional medicines, which can be useful in developing new treatment technologies.Trial registrationKCT0001768. Registered on 14 January 2016.

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

BackgroundThis study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD).MethodA systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0–13), and a combined key methodological index score (MIS) (range 0–5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0–17) was also measured.ResultsIn total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and “trial design,” “sample size,” “ancillary analyses,” and “harms” had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with “allocation concealment and implementation,” “blinding,” and “intent-to-treat analysis” having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with “extent to which treatment was varied (1c),” “number of needle insertions per subject per session (2a),” and “setting and context of treatment (4b)” having a positive rate of less than 10%.ConclusionsThe overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.

Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke

BackgroundThis study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke.MethodsThe following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured.ResultsThe original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items ‘trial design’, ‘sample size’, ‘ancillary analyses’, and ‘harms’ had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with ‘allocation concealment and implementation’ and ‘intent-to-treat analysis (ITT) analysis’ having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items ‘sample size’ and ‘intent-to-treat analysis’ were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; pxa0<xa00.001). No variable was significantly associated with MIS in the ordinal regression model.ConclusionThe quality of reports on RCTs investigating scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture for stroke, CONSORT and STRICTA guidelines should be utilized more frequently.

Neurorestorative effects of epigallocatechin-3-Gallate on cognitive function in a chronic cerebral hypoperfusion rat model.

PURPOSEnThis study investigated whether (-)-epigallocatechin-3-gallate (EGCG) can enhance cognition by a neurorestorative effect in a rat model of bilateral common carotid artery occlusion (BCCAO).nnnMETHODSnForty-eight male, 8-week-old Sprague-Dawley rats were randomly allocated to four groups 6 weeks after BCCAO or sham operation: EGCG-single intravenous injection (25u200amg/kg/day; SIV group), EGCG-multiple intraperitoneal injection (50u200amg/kg/day for 5 days; MIP group), untreated BCCAO group (untreated group), and sham-operated group (sham group).nnnRESULTSnEscape latency was significantly shorter in the SIV and MIP groups than in the untreated group. SIV and MIP groups were significantly different from the untreated group in the activity of superoxide dismutase and the content of malondialdehyde (pu200a<u200a0.05). Protein expression level of brain-derived neurotrophic factor was not significantly different between groups (pu200a>u200a0.05), while protein expression of vascular endothelial growth factor was significantly lower in the SIV group than in the untreated group (pu200a<u200a0.05). Protein expression of N-methyl-D-aspartate receptor subunits NR1 and NR2B was significantly higher in the MIP group than in the untreated group (pu200a<u200a0.05).nnnCONCLUSIONSnEGCG administration at 6 weeks after BCCAO is neurorestorative via an anti-oxidant effect and synaptogenesis, except for angiogenesis.

A novel taping therapy for pain after arthroscopic shoulder surgery: study protocol for a randomised controlled pilot trial

BackgroundIn recent years, the number of arthroscopic shoulder surgeries has increased given that the intervention is minimally invasive. However, postoperative pain is one of the most common symptoms of patients who undergo arthroscopic surgery. Although pharmacological treatments and brachial plexus blocks for reducing pain are currently used, the adherence rate of interventions is low, and adverse effects often occur. Chimsband, made up of silver and optic fibres, is a novel taping therapy that stimulates patients’ acupoints and is expected to relieve pain with few adverse effects. The aim of this study is to explore the effectiveness of Chimsband to relieve pain following arthroscopic shoulder surgery.Methods/designThis is a randomised, parallel, controlled, exploratory clinical trial. Thirty participants who undergo arthroscopic shoulder surgery will be randomly allocated to an intervention or a control group. Both groups will receive 10 sessions of interferential current therapy within a period of 2 weeks, while the intervention group will additionally receive taping therapy after undergoing physical therapy. Two follow-up visits will be scheduled after the last treatment session. The primary outcome variable will be the difference in the visual analogue scale (VAS) scores between baseline and first follow-up evaluation after the end of 10 treatment sessions. The secondary outcomes will be VAS at the end of the second week, shoulder pain and disability index, range of motion, VAS while sleeping, questionnaire of blood stasis pattern identification at two follow-up visits, and number of bands used per visit. Outcomes will be evaluated at baseline, 2 weeks from visit 1 (+ within 6xa0days) after commencement, and at 4 weeks from visit 1 (+ within 6xa0days) follow-up.DiscussionThis study will be the first clinical trial to explore the effect and safety of Chimsband on postoperative shoulder pain. It would provide clinical evidence to conduct further taping therapy studies for relieving musculoskeletal pain.Trial registrationKorean Clinical Trial Registry, KCT0002355. Registered on 13 June 2017.

The effects of Kinesiotape on acute lateral ankle sprain: study protocol for a randomized controlled trial

BackgroundAnkle sprains are some of the most frequent injuries of the musculoskeletal system. However, there is no substantive evidence supporting which treatment strategy is superior. Taping with Kinesiotape (KT) is a new method that is used as an alternative to the more established taping and bracing techniques used for the prophylaxis and treatment of ankle sprains. The aim of this study is to examine the efficacy of KT on ankle sprain by comparing acupuncture combined with KT (AcuKT) with acupuncture alone in patients with acute lateral ankle sprains.Methods/designThis study is a prospective, multi-center (DongShin University Gwangju Oriental Hospital, DongShin University Mokpo Oriental Hospital, and KyungHee Korean Medicine Hospital), outcome assessor-blinded, randomized controlled clinical trial with a 1:1 allocation ratio. Participants (n = 60) with a lateral ankle sprain occurring within 1 week of the study will be randomly assigned to either an acupuncture group (n = 10 at each center (total n = 30)) or an AcuKT group (n = 10 at each center (total n = 30)). The acupuncture group will receive acupuncture treatment at ST36, ST41, BL60, BL62, KI3, KI6, GB39, and GB40 once per day, 5 days per week (excluding Saturday and Sunday) for 1 week. The AcuKT group will receive acupuncture treatment at ST36, ST41, BL60, BL62, KI3, KI6, GB39, and GB40 and the ankle meridian tendino-musculature and a figure-of-eight shape form of KT treatment once per day, 5 days per week (excluding Saturday and Sunday) for 1 week. The primary outcome will be pain evaluation assessed according to a Visual Analogue Scale (VAS), while Foot and Ankle Outcome Score (FAOS), edema, European Quality of Life Five Dimension-Five Level Scale (EQ-5D-5 L) score, and number of recurrent ankle sprains will be considered as secondary outcome measures. VAS, FAOS, and edema measurements will be performed at baseline (before intervention), 5 days after the first intervention (i.e., at the end of the intervention), and 4 weeks after the completion of intervention. EQ-5D-5 L measurements will be conducted at baseline, 5 days after the first intervention, 4 weeks after the completion of intervention, and 26 weeks after the completion of intervention. The number of recurrent ankle sprains will be determined at 4, 8, 12, and 26 weeks after the completion of the intervention.DiscussionThis study will provide data regarding the efficacy of KT for the treatment of acute lateral ankle sprain. The results may lead to insights into the usefulness of KT in the treatment of acute lateral ankle sprain.Trial registrationcris.nih.go.kr, ID: KCT0002257. Registered on 27 February 2017, and approved by the Ministry of Food and Drug Safety (Medical Device Clinical Trial Plan Approval #737).

Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial

BackgroundAnkle sprain is a common musculoskeletal injury. In Korean medicine, blood stasis is thought to be the main cause of pain and swelling in patients with ankle sprain. Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine for the treatment of traumatic ecchymosis and pain by promoting blood circulation and relieving blood stasis. However, the effects of DS on ankle sprain have not been evaluated in a randomized clinical trial. Here, we describe the protocol for a randomized controlled trial that will evaluate the efficacy and safety of DS for the treatment of ankle sprain.Methods/designIn this randomized, double-blinded, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio, participants (n = 48) with acute lateral ankle sprain (ALAS) that occurred within 72 h before enrollment will be randomly assigned to a DS (n = 24) or a placebo (n = 24) group. Both groups will receive acupuncture treatment once a day for 5 days a week (excluding Saturday and Sunday) and the trial medication (DS/placebo capsule) three times a day for seven consecutive days. The primary outcome measure will be pain relief evaluated using a Visual Analog Scale (VAS). Secondary outcome measures will include Foot and Ankle Outcome Scores (FAOS), edema, European Quality of Life Five-Dimension-Five-Level Scale (EQ-5D-5 L) scores, and the number of recurrent ankle sprains. VAS, FAOS, edema, and EQ-5D-5 L scores will be recorded before, at the end of, and at 4 weeks after treatment completion. EQ-5D-5 L scores will be additionally recorded at 26 weeks after treatment completion. The number of recurrent ankle sprains will be recorded at 4, 8, 12, and 26 weeks after treatment completion.DiscussionThis study is expected to provide evidence regarding the efficacy, safety, and usefulness of DS for the treatment of ALAS.Trial registrationcris.nih.go.kr, registration number: KCT 0002374. Registered on 11 July, 2017 and approved by the Ministry of Food and Drug Safety (registration number, 31244).

Acupuncture for prehypertension and stage 1 hypertension in postmenopausal women: A randomized controlled pilot trial

Incidence of cardio vascular diseases and cardiac deaths show an increasing tendency nnow. At present, people are living longer and their changed life style pattern is also an important nfactor in causing an increased incidence of cardiac diseases amongst the present npopulation..Now, there are various modalities of treatment available for treating cardiac ndiseases especially in elderly people (1). The present case is a typical example of an acute ncoronary syndrome in a nonagenarian and the dilemma faced by the treating cardiologist.........................................................................................................4 Introduction and Background.............................................................................6 Review of Evidence...........................................................................................9 Problem Statement..........................................................................................17 Purpose.........................................................................................................17 Theoretical Framework....................................................................................17 Project Design.................................................................................................22 Clinical Setting.......................................................................................23 Project Population...................................................................................23 Sources of Data/Data Collection Instruments....................................................25 Data Collection Process/Procedures..............................................................28 Results.........................................................................................................30 Background Assessment............................................................................30 Characteristics of the Hospital Discharge Process and Discharge Demographics.........31 Adherence to Guideline Directed Heart Failure Care..........................................32 Discussion.....................................................................................................33 Bi-Directional Communication....................................................................33 Structure-Process-Outcomes Evaluation.........................................................34 Adherence to Guideline Directed Heart Failure Care...........................................35 Strengths and Limitations..........................................................................37 Conclusion....................................................................................................37 References.....................................................................................................40 DEVELOPING A GUIDELINE 3 Appendix and Tables.......................................................................................47 Appendix A. Heart Failure Studies Located in Skilled Nursing Facilities...................47 Appendix B. Transition of Care Models..........................................................51 Appendix C. Applying Donabedian’s SPO Model to the Iowa Model of Evidence Based Practice to Promote Quality Care..........................................55 Appendix D. Structured Follow up Phone Call Survey.......................................56 Appendix E. Heart Failure Handoff Tool.......................................................57 Appendix G. Survey One..........................................................................58 Appendix F. Survey Two..........................................................................59 Appendix H. Letter to Skilled Nursing Facilities...............................................61 Table 1. Demographic Characteristics of SNF Providers......................................62 Table 2. Survey One Results.......................................................................63 Table 3. Demographic Characteristics of Heart Failure Clinic RNs.........................64 Table 4. Survey Two Results......................................................................65 Table 5. Characteristics of the Hospital Discharge Process...................................66 Table 6. Association Between Guideline Directed Heart Failure Care and Handoff Form.............................................................................67 Table 7. Association Between Adherence to Guideline Directed Heart Failure Care and SNF Partnership................................................................68 Table 8. Association Between Adherence to Guideline Directed Heart Failure Care and Completion of Discharge Summary at the time of Discharge.........67 DEVELOPING A GUIDELINE 4