• Title/Summary/Keyword: non-randomized controlled trial

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Changes in body weight, blood pressure and selected metabolic biomarkers with an energy-restricted diet including twice daily sweet snacks and once daily sugar-free beverage

  • Nickols-Richardson, Sharon M.;Piehowski, Kathryn E.;Metzgar, Catherine J.;Miller, Debra L.;Preston, Amy G.
    • Nutrition Research and Practice
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    • v.8 no.6
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    • pp.695-704
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    • 2014
  • BACKGROUND/OBJECTIVES: The type of sweet snack incorporated into an energy-restricted diet (ERD) may produce differential effects on metabolic improvements associated with body weight (BW) loss. This study compared effects of incorporating either twice daily energy-controlled dark chocolate snacks plus once daily sugar-free cocoa beverage (DC) to non-chocolate snacks plus sugar-free non-cocoa beverage (NC) into an ERD on BW loss and metabolic outcomes. MATERIALS/METHODS: In an 18-week randomized comparative trial, 60 overweight/obese premenopausal women were assigned to DC (n = 30) or NC group (n = 30). Dietary intake was measured at baseline and week 18, and BW, anthropometrics, blood pressure (BP) and serum glucose, insulin and lipid concentrations were measured at baseline, and weeks 6, 12 and 18. Data were analyzed using repeated measures ANOVA. RESULTS: Using intention-to-treat analysis, women in DC and NC groups reduced energy intake (both P < 0.001) and lost $4.4{\pm}0.6kg$ and $5.0{\pm}0.9kg$ (both P < 0.001), respectively. Both groups lowered systolic and diastolic BP [DC = 2.7 (P < 0.05), 2.7 (P < 0.01); NC = 3.4 (P < 0.01), 4.2 (P < 0.01) mmHg, respectively]. Glucose and insulin concentrations decreased by 0.72 mmol/L (P < 0.001) and 13.20 pmol/L (P < 0.01) in DC group and by 0.83 mmol/L (P < 0.001) and 13.20 pmol/L (P < 0.01), respectively, in NC group. Total cholesterol increased in NC group (P < 0.05), with no significant lipid changes in DC group. There were no significant differences in biomarker outcomes between groups. CONCLUSIONS: Overweight/obese premenopausal women following an 18-week ERD that included either DC or NC sweet snack and sugar-free beverage lost equivalent amounts of BW and improved BP measurements and glucose and insulin concentrations.

Clinical Trial Protocol Development of Acupuncture for Disaster Survivors: Results from an Expert Survey (전문가 설문조사에 기반한 재난 경험자에 대한 침치료 임상연구 프로토콜 개발)

  • Huiyong Kwak;Chanyoung Kwon;Jungtae Leem;Sang-Ho Kim
    • Journal of Oriental Neuropsychiatry
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    • v.35 no.1
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    • pp.15-26
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    • 2024
  • Objectives: The objective of this study is to develop a specialized clinical research protocol for acupuncture treatment specifically designed for disaster survivors based on insights from an expert survey. Methods: An expert panel comprising specialists in neuropsychiatry, acupuncture, and clinical research methodology was assembled. Initial data to inform the clinical research protocol design was collected utilizing open-ended responses, multiple-choice questions, and a 5-point Likert scale to gauge agreement levels. Next, this data was disseminated to a panel of experts. A cohesive clinical research protocol was then formulated during a core panel meeting by integrating insights from a panel of 10 experts. Results: The protocol developed herein entails a non-randomized controlled study involving participants aged 19~64 years old who have been identified as high-risk or cautious according to the National Trauma Center screening test. The study design includes the establishment of an active control group, which allows for the assessment of an additional effect through comparison with conventional therapy. The selected acupuncture approach involves a combination of manual acupuncture and ear acupuncture. For clinical outcome assessment, the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 was proposed to gauge trauma symptoms. Representative scales for various domains such as depression, anxiety, anger, insomnia, pain, and quality of life were also provided for reference. Conclusions: The developed protocol is anticipated to streamline the swift design and initiation of clinical trials during disaster scenarios. It is also designed to be scalable, thereby enabling its application in both non-randomized control group studies and single-group before-and-after comparisons.

Investigation of changes in abdominal cavity between dyspepsia patients and healthy participants when pressure pain occurs using an algometer combined with an ultrasound device: a non-randomized, controlled, pilot trial (초음파 결합형 압통계를 활용한 압통시 소화불량 환자와 건강인의 복강내 조직 변화 비교: 비무작위 대조군 예비 임상시험)

  • Jinwoong Lim;Taeseong Jeong;Hoseok Jung;Sunny Kang;Chang-Min Choi;Dong Woung Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.27 no.1
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    • pp.43-52
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    • 2023
  • Objectives : The aim of this study was to evaluate the differences in the abdominal cavity between functional dyspepsia patients and healthy people using an algometer combined with an ultrasound device. Methods : A non-randomized, controlled, pilot trial was conducted. Thirty patients in the experimental group and fifteen participants in the control group were recruited. We collected demographical data, and measured abdominal circumference, height of the body cavity, subcutaneous fat thickness, visual analogue scale of dyspepsia symptoms in the experimental group, depth of algometer and pressure of algometer when pressure pain occurred, and the whole ultrasonic image from the beginning of pressurization to the time when pressure pain occurred. The measurements were carried out twice with the duration of 1 week. Generalized linear regression was conducted to adjust baseline characteristics. Results : A total of 45 participants (30 in experimental group, 15 in control group) were recruited and finished the trial. Females were recruited more in the experimental group than in the control group and it was statistically significant. The difference in thickness of abdominal cavity between a second before the pressure pain and at the time when pressure pain occurred was statistically significant on 1st visit, and other measurements were not statistically significant. From the results of the regression analysis, the difference between two groups was statistically significant in the differences in the thickness of stomach and up to abdominal aorta on 1st visit, and the thickness of stomach on 2nd visit, and other measurements were not statistically different. Conclusions : According to the results, there were not statistically significant differences in abdominal examination when pressure pain occurred between dyspepsia patients and healthy people. Further studies are warranted to assess the abdominal examination using devices including algometer and ultrasound devices, regarding the results of the present study.

EEG Changes due to Low-Frequency Electrical Stimulation to the BL62 and KI6 of Elderly Women (노년 여성의 신맥.조해 저주파 자극이 뇌파에 미치는 영향)

  • Lee, Sanghun;Choi, Kwang-Ho;Cho, Seong Jin;Choi, Sun-Mi;Hong, Kwon Eui;Ryu, Yeon-Hee
    • Korean Journal of Acupuncture
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    • v.30 no.2
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    • pp.135-142
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    • 2013
  • Objectives : This study aimed to investigate the general effects of low-frequency electrical stimulation of the ankle joint acupuncture points(BL62 and KI6) on the brain waves of elderly women as a pilot study to figure out the possibility of candidate non-invasive and non-chemical stimulation method for the enhancing the brain function. Methods : A randomized, controlled, double-blinded clinical trial was performed in 31 healthy women(mean age, 54.5 years) within a treatment duration of 12 sessions. In the experimental group, low-frequency electrical stimulation was applied using the maximum range of the individual insensible strength(mean current, $0.04{\mu}A$). The control group received sham stimulation. The background electroencephalographic activity was measured before and after the12 sessions. Results : After 12 sessions of stimulation, the relative power of the alpha wave increased(32 of 32 channels: significant difference in 11 channels, p<0.05); the theta(30 of 32 channels: significant difference in 10 channels, p<0.05), beta(31 of 32 channels), and gamma(30 of 32 channels: significant difference in 7 channels, p<0.05) powers were also decreased compared with the sham group. Conclusions : Electrical stimulation on the ankle joint acupuncture points(BL62 and KI6) seemed to stabilize the elderly women brain by inducing the alpha power and reducing beta, theta, and gamma powers. These results provide insight into the action mechanism of the stimulation and can assist the future developement of a non-invasive and non-chemical treatment technique for stressor related cognitive problems.

Research Trends on the Treatment of Lumbar Herniated Intervertebral Disc in Korean Medicine (요추 추간판 탈출증의 한의학적 치료에 대한 국내연구동향)

  • Cho, Hyoung-Jun;Sul, Jae-Uk;Shin, Mi-Sook
    • Korean Journal of Acupuncture
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    • v.29 no.4
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    • pp.501-518
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    • 2012
  • Objectives : To research trends of studies on treatments of lumbar herniated intervertebral disc in Korean medicine. Methods : We searched papers using Korean Traditional Knowledge Portal, OASIS, KISS. We used "low back pain", "radiculopathy", "lumbar herniated intervertebral disc" as keyword. Limitations were as follows; Domestic studies, published from 2000 to 2011, mentioning the treatments of lumbar herniated intervertebral disc in Korean medicine. This study researched and classified the papers according to the fields of the treatment and methods of study. Results : The results were obtained as below ; 1. The number of papers published in 2000 was only three, but steadily increased to 15 in 2010 and the total number of papers was 93. 2. When categorized according to the fields of treatment, 93 researches are classified as acupuncture, moxibustion, Chuna therapy, drug, various physical therapies and collaborative Oriental-Western medicine therapy. 3. When categorized according to the methods of study, 70 researches were the simple case report and non-RCT(non-randomized controlled trial) were 11 and RCT(randomized controlled trials) has been reported in 11 researches. 4. General assessment tools were VAS, ODI before, however these days, Physical examination(ROM, SLRT, etc.), Radiologic tests(MRI, X-ray), DITI etc. are used more in order to evaluate objective therapeutic effects. Conclusions : These results indicate that researches on lumbar herniated intervertebral disc in Korean medicine have been investigated by various method and steadily increasing.

Analysis of Randomized Controlled Trial Study of Korean Herbal Medicine Treatment for Acne (여드름 한약 치료의 무작위 대조군 임상연구에 관한 분석)

  • Lee, Ma-Eum;Kwon, Kang;Jee, Seon-Young;Hwangbo, Min;Kim, Chul-Yun;Seo, Hyung-Sik
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.35 no.4
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    • pp.139-162
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    • 2022
  • Objectives : The review was conducted to validate the effectiveness of herbal medicines on acne. Methods : Randomized controlled trials(RCTs) reporting the effects of herbal medicine treatment on acne were searched through seven electronic databases from the time of application of the material to October 2021. Cochrane Collaboration's Risk of Bias was used to assess the risk of bias. Analysis was performed using Review Manager 5.4 and R 4.1.0 Meta, Metafor program. Results : 34 RCTs was selected and meta-analysis was performed with 30 studies. The inflammatory lesion count of the herbal medicine(MD=0.29, 95% CI:-0.59-0.01, p<0.01, I2=80%) and the non inflammatory lesion count of herbal medicine(MD=-0.30, 95% CI:-0.70-0.10, p<0.01, I2=78%) were seen. The score of IGA(RR=1.43, 95% CI:0.90-2.27, p<0.91, I2=0%), VISIA(MD=0.36, 95% CI:0.21-0.51, p=0.07, I2=40%), effective rate(RR=1.23, 95% CI:1.05-1.44, p<0.01, I2=98%), DLQI(MD : 0.59, 95% CI:0.14-1.04, p=0.07, I2=63%) and recurrence rate(RR=0.36, 95% CI:0.23-0.58, p=0.73, I2=0%) were seen. The effective rate of herbal medicine were statistically higher that of the control group(WM)(RR=1.19, 95% CI:1.04-1.37, p<0.01, I2=97%). As a result of dividing the treatment groups into OHM, EHM, and OEHM, the EHM group(RR=1.17, 95% CI:0.79-1.72, p<0.01, I2=99%) showed the most statistically significant effect. The overall risk of bias of the included studies was some concerns. No serious adverse effects were observed. Conclusions : This review found the effectiveness of herbal medicine for acne.

Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study (만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구)

  • Gong, Han Mi;Jun, Seungah;Chung, Yeon-Joong;Kim, Ju-Ran;Lee, Jung Hee;Lee, Hyun-Jong;Park, Chung A;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.37 no.1
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

Effect of Paretic Side and Non-paretic Side Arm Training on Trunk Control and Upper Limb Functions in Stroke Patients

  • Kim, Teahyun;Son, Yuhyeon;Park, Shinjun
    • Journal of International Academy of Physical Therapy Research
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    • v.10 no.1
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    • pp.1734-1738
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    • 2019
  • Background: Stroke patients usually have arm weakness, which affects trunks and arms. Objective: To investigate the effects of paretic side and non-paretic side arm training on trunk control and upper limb functions. Design: Randomized Controlled Trial (single blind). Methods: Twenty patients with stroke in hospital were enrolled in the study. Twenty subjects were randomly assigned to paretic side arm training group (PATG, n = 10) or non-paretic side arm training group (NATG, n = 10). Trunk impairment scale (TIS) was used for trunk control, and box and block test (BBT) was used for upper limb function. Training was conducted for 4 weeks. Results: PATG showed significant difference in TIS (static balance, dynamic balance, coordination, total score) and BBT. NATG showed significant differences in static balance, and dynamic balance and total score except for coordination and BBT. PATG also showed a more significant difference in BBT and coordination and total score than NATG. Conclusions: The arm training performed on the paretic side are more effective than those performed on the non-paretic side in improving both upper limb function and trunk control in stroke patients.

Effects of Breathing Exercise of Pilates on Dysfunction and Lumbar Flexibility in Patients with Chronic Non-Specific Low Back Pain

  • Sooyong Lee;Yusik Choi
    • Physical Therapy Rehabilitation Science
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    • v.12 no.3
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    • pp.268-277
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    • 2023
  • Objective: The purpose of this study was to investigate the effects of Pilates breathing exercises on functional disability and lumbar flexibility in patients with non-specific chronic low back pain. Design: A randomized controlled trial. Methods: 30 patients with non-specific low back pain were selected and classified into an experimental group (n=15) and a control group (n=15). Both groups were assessed for functional disability using the Oswestry Disability Index and flexibility of the lumbar spine using the modified-modified Schober test before and after the intervention. The intervention was applied twice a week for four weeks. The experimental group performed Pilates breathing exercises followed by spinal stabilization exercises, while the control group only performed spinal stabilization exercises. Results: Both groups showed significant improvements in functional disability and lumbar flexibility after the intervention. However, when comparing between the two groups, the experimental group showed a more significant effect than the control group. Conclusions: The combination of Pilates breathing exercises and spinal stabilization exercises can be considered an effective approach to improve low back pain and prevent chronic pain in patients with non-specific chronic low back pain.

The effects of EMG-triggered functional electrical stimulation on upper extremity function in stroke patients

  • Kim, Young
    • Physical Therapy Rehabilitation Science
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    • v.2 no.1
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    • pp.1-6
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    • 2013
  • Objective: The aim of this review is to explore the latest intervention trends and effects of EMG-triggered functional electrical stimulation on the upper extremity functions in stroke patients. Design: Systematic review on clinical trials. Methods: A systematic literature search was performed to identify clinical trials evaluating the effects of EMG-triggered functional electrical stimulation (EMG-FES) and task-oriented EMG-triggered FES on the hand functions in stroke patients. Literature review was conducted with the following key words: hand function, functional electrical stimulation, task-oriented, stroke. Results: Ten clinical trials were included; 8 of them were randomized controlled trial, 1 was block-randomized, and 1 was a pre-post comparison study. A positive effect of electrical stimulation was reported in the patient groups that were treated with functional electrical stimulation combined with specific tasks, and volitional muscle contraction-triggered stimulation that was synchronized with tasks. Motor capabilities of the hand and arm were improved after the rehabilitation. Conclusions: EMG-triggered electrical stimulation may be more effective than non-triggered electrical stimulation in facilitating the hand functions in stroke patients in terms of muscle strength and voluntary muscle contraction of the paretic hand and arm. Triggered electrical stimulation can be even more effective when it is combined with specific tasks.

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