• Title/Summary/Keyword: Placebo-controlled

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Effects of Interferential Current Treatment on Pain, Functional Ability, and Health-Related Quality of Life in Chronic Stroke Patients with Lumbago; A Randomized Controlled Study

  • Jung, Kyoung-Sim;In, Tae-Sung
    • Journal of the Korean Society of Physical Medicine
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    • v.15 no.1
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    • pp.25-32
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    • 2020
  • PURPOSE: This study examined the efficacy of an interferential current (IFC) treatment on the improvement of pain, disability, and quality of life in stroke patients with lumbago. METHODS: A double-blind, randomized clinical trial was conducted on 40 stroke patients with lumbago. The patients were allocated randomly into two groups: the IFC treatment group (n= 20) and the placebo treatment group (n= 20). The IFC group received 30 minutes of IFC treatment on the lumbar region, while the placebo group received IFC treatment but without real electrical stimulation. The intervention was administered five days a week for four weeks. The primary outcomes of pain intensity were measured using a visual analogue scale. The secondary measurements included the Barthel Index, Oswestry Disability Index (ODI), and health-related quality of life (HRQoL). RESULTS: The measurements were conducted before and after the two-week intervention period. Compared to the placebo treatment group, the IFC treatment group showed significantly greater improvement in the pain intensity (p<.05), ODI (p<.05), and SF-36 (p<.05) at the end of the intervention. No significant differences in the Barthel Index were found between the two groups. CONCLUSION: These findings show that an IFC treatment can improve pain, functional ability, and quality of life, highlighting the benefits of somatosensory stimulation from IFC in stroke patients with lumbago.

Clinical study on the effects of a composition containing oriental medicine for eye symptoms of VDT syndrome (한방조성물이 VDT 증후군의 안 증상 개선에 미치는 임상효능연구)

  • 최선미;김선형;안상기;성현제;윤유식
    • The Journal of Korean Medicine
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    • v.24 no.2
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    • pp.109-120
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    • 2003
  • Objectives: This study was conducted to evaluate the clinical efficacy of EC102, a composition containing oriental medicine, for relieving VDT syndrome, including eye symptoms and musculo-skeletal symptoms. Methods: The study was conducted by using a double blind randomized controlled trial design. 40 subjects were randomly assigned to the placebo group or the EC102 group. The visual analogous scale (VAS) was used to evaluate various VDT symptoms, including eye pain, eye fatigue, back pain, shoulder pain and so on. Refractory indexes were measured using refractometer, and tear film break-up time (BUT) were measured using fluorescein strip. Blood circulation was measured using photo-plethysmography. Blood pressure and blood biochemistry were also measured. Statistical analysis was conducted by a Mann-Whitney test using SPSS 9.0 software. Results: The EC102 group showed a statistically significant reduction of eye symptoms including eye fatigue, eyelid fatigue, itching, pain, and photophobia when compared with the placebo group (P<0.05). The EC102 group also showed a statistically significant reduction of back pain compared with the placebo group (P<0.05). No side effects on liver function and blood biochemistry were observed. Conclusions: EC102 has significant clinical efficacy for relieving symptoms of VDT syndrome.

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Effects of Interferential Current Treatment on Pain, Disability, and Balance in Patients with Chronic Low Back Pain: A Randomized Controlled Study

  • Jung, Kyoung-Sim;In, Tae-Sung
    • Journal of the Korean Society of Physical Medicine
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    • v.15 no.3
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    • pp.21-27
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    • 2020
  • PURPOSE: This study investigated the efficacy of interferential current (IFC) treatment on the improvement of pain, disability, and balance in patients with chronic nonspecific low back pain. METHODS: A double-blind randomized clinical trial was conducted with 40 patients with chronic nonspecific low back pain. The patients were randomly allocated into two groups: the IFC treatment group (n = 20) and the placebo treatment group (n = 20). The IFC group received 30 minutes of IFC treatment on the lumbar region, while the placebo group received IFC treatment without real electrical stimulation. The intervention was administered five days a week for two weeks. RESULTS: The primary outcomes of resting pain and pain during functional movement were measured by a visual analogue scale. The secondary measurements included the Oswestry disability index (ODI) for low back pain and postural sway. The measurements were performed before and after the two-week intervention period. Compared to the placebo treatment group, the IFC treatment group showed significantly greater improvement in pain during anterior trunk flexion in the standing position (p = .029), ODI (p = .039), and postural sway when subjects stood with their eyes closed (p = .010) at the end of the intervention. CONCLUSION: Our findings show that IFC treatment can improve pain, disability, and postural sway, thus, highlighting the benefits of somatosensory stimulation from IFC.

Conjugated Linoleic Acid (CLA) Supplementation for 8 Weeks Reduces Body Weight in Healthy Overweight/Obese Korean Subjects

  • Park, Eun-Ju;Kim, Jung-Mi;Kim, Kee-Tae;Paik, Hyun-Dong
    • Food Science and Biotechnology
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    • v.17 no.6
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    • pp.1261-1264
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    • 2008
  • In the present study, a randomized, double-blind, placebo-controlled trial to determine the effect of conjugated linoleic acid (CLA) supplementation (50:50 ratio of cis-9, trans-11 and trans-10, cis-12 isomers) for 8 weeks on body composition and biochemical parameters in healthy overweight/obese (body mass index, BMI${\geq}23\;kg/m^2$) Korean subjects was performed, Thirty participants (3 males and 27 females) were randomized to receive placebo (2.4 g olive oil/day) or 2.4g/day CLA (mixture containing 36.9% of cis-9, trans-11 and 37.9% of trans-10, cis-12). Eight weeks of CLA supplementation significantly decreased body weight by -0.75kg, BMI by $-0.27\;kg/m^2$, and hip circumference by -1.11 cm. The reduction of body weight was ascribed to the reduction of body fat mass (-0.59 kg) and lean body mass (-0.18 kg), although these changes were not significant. No significant differences in serum lipid profiles, liver function enzyme activities, and protein concentration were observed in either the CLA or placebo groups. These results indicate that short tenn supplementation (8 weeks) with CLA (2.4 g/day) may decrease body weight in Korean overweight/obese subjects.

Immediate Effects of Ankle Eversion Taping on Balance and Gait Function in Patients with Chronic Stroke: A Randomized Controlled Trial

  • Hye-In Bae;Myeong-Ho Lee;Myoung-Kwon Kim
    • Journal of the Korean Society of Physical Medicine
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    • v.18 no.2
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    • pp.1-11
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    • 2023
  • PURPOSE: This study examined the immediate effects of applying ankle eversion taping using kinesiology tape in chronic stroke patients-design: a randomized cross-over trial. METHODS: Seventeen stroke patients underwent three interventions in random order. The subjects were initially assigned randomly to an ankle eversion taping, placebo taping, or no taping for each intervention. Ankle eversion taping was used for mechanical correction and was involved in ankle dorsiflexion and eversion. The tape was stretched by 30-40%. Placebo tapping was applied in the same form as eversion tapping but was not stretched. The balance ability was assessed using the Y-balance test. The gait ability was assessed by maximum foot pressure and time of stance phase, and gait speed was assessed using a 10 m walk test (10MWT). All measurements were performed immediately after the intervention. RESULTS: The results showed that the dynamic balance and stance phase time in chronic stroke patients was improved after ankle eversion taping. The ankle eversion taping conditions increased significantly (p < .05) compared to the placebo and no taping conditions. CONCLUSION: The application of ankle eversion taping that uses kinesiology tape instantly increased the gait ability of chronic stroke patients. On the other hand, more research will be needed to identify the long-term effects of ankle eversion taping.

Dietary effect of Lactobacillus plantarum CJLP55 isolated from kimchi on skin pH and its related biomarker levels in adult subjects (김치유산균 Lactobacillus plantarum CJLP55 섭취가 성인 남녀의 피부 산도 및 관련 구성 인자의 변화에 미치는 영향)

  • Han, Sangshin;Shin, Jihye;Lim, Sunhee;Ahn, Hee Yoon;Kim, Bongjoon;Cho, Yunhi
    • Journal of Nutrition and Health
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    • v.52 no.2
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    • pp.149-156
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    • 2019
  • Purpose: The skin pH is maintained by epidermal lactate, free fatty acids (FFAs), and free amino acids (FAAs). As a significant determinant of skin health, the skin pH is increased (less acidic) under abnormal and aged skin conditions. In a search for dietary alternatives that would promote an acidic skin pH, this study investigated the dietary effects of Lactobacillus plantarum CJLP55 isolated from Korean kimchi on the skin pH, and epidermal levels of lactate, FFAs, and FAAs in adult subjects. Methods: Seventy eight subjects (mean age $24.9{\pm}0.5years$, range 19 ~ 37 years) were assigned randomly to ingest CJLP55, Lactobacillus strain from kimchi, (n = 39, CJLP group) or placebo supplements (n = 39, placebo group) for 12 weeks in a double-blind, placebo-controlled trial. Skin pH and epidermal levels of lactate, FFAs and FFAs were assessed at 0, 6 and 12 weeks. Results: Although significant decreases in skin pH were observed in both the CJLP and placebo groups at 6 weeks, the skin pH was decreased significantly only in the CJLP group at 12 weeks. In parallel, the epidermal level of lactate in the CJLP group was also increased by 25.6% at 12 weeks. On the other hand, the epidermal level of FAAs were not altered in the CJLP and placebo groups, but the epidermal level of total FFAs, including palmitic acid and stearic acid, was lower in the CJLP group than in the placebo group over 12 weeks. The changes in the other FFAs, such as palmitoleic acid and oleic acid, were similar in the CJLP and placebo groups over 12 weeks. Conclusion: Overall, a dietary supplement of CJLP55 promotes acidic skin pH with a selective increase in epidermal lactate in adult subjects.

Effects of Punica granatum (Pomegranate) Extracts on the Menopause Women

  • Kim, Hyung-Jun;Kwon, Do-Hyeong;Kum, Eun-Joo
    • Biomedical Science Letters
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    • v.16 no.1
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    • pp.53-64
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    • 2010
  • A randomized, double blind, placebo-controlled human intervention study involving 58 menopause women was performed to investigate the effect of pomegranate extracts on menopausal symptoms. The volunteers were randomly distributed into two groups, one taking pomegranate extracts (1.5 g/day) and the other being a placebo by taking oral administration for 8 weeks. The results from this study showed that duration of hot flush and sweating were significantly decreased by taking pomegranate extracts. In addition, menopausal rating scales and the Kuppermann index were significantly decreased in pomegranate extract taking group. This result suggests a possibility that pomegranate extracts can be helpful for menopause women.

The Influences of Pulsed Electromagnetic Field Treatment Following Experimentally Induced Delayed-Onset Muscle Soreness in Biceps Brachii (펄스자기장이 위팔 두갈래근의 지연성 근육통에 미치는 영향)

  • Kang, Sun-Young;Park, Joo-Hee;Jeon, Hye-Seon;Lee, Hyun-Sook
    • Physical Therapy Korea
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    • v.20 no.2
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    • pp.11-19
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    • 2013
  • Delayed onset muscle soreness (DOMS) is a painful condition that arises from exercise-induced muscle damage after unaccustomed physical activities. Various therapeutic interventions have been applied to reduce the intensity and duration of DOMS-related symptoms. Recently, pulsed electromagnetic field (PEMF) intervention has been introduced as an alternative noninvasive treatment for DOMS. This randomized, double-blind, placebo-controlled experiment was conducted to examine the effects of PEMF therapy on DOMS in elbow flexors at 24, 48, and 72 hours after the experimental DOMS induction. Thirty healthy volunteers ($23{\pm}2.4$ yrs, $175{\pm}5.7$ cm, and $74{\pm}7.8$ kg) participated in this study. Each was randomly assigned to a PEMF or placebo group. On the first day, DOMS was induced in the elbow flexors by repeated isokinetic motions at low ($60^{\circ}/s$) and fast ($120^{\circ}/s$) speeds in all subjects. Thereafter, the PEMF group received 15-min daily treatment with a PEMF device. The placebo group received sham treatment of the same duration. Overall, PEMF application was more effective than the sham treatment in reducing the physiological symptoms associated with the DOMS including perceived soreness, median frequency, and electromechanical delay of the surface electromyography. In addition, median frequency and isokinetic peak torque of the PEMF group recovered to the pre-DOMS induction level earlier than the placebo group. In conclusion, this study suggests that PEMF can be applied as a new recovery strategy in reducing DOMS symptoms. Further experiments are required to examine the effect of the PEMF treatment on different types of exercise conditions and to determine the optimal treatment dosage and duration in a real clinical setting.

Adverse Event Study on Ojeok-san Extract Powders RCT in Low Back Pain Patients (요통환자 대상 오적산 엑스산 투여 임상시험 이상반응 연구)

  • Yoon, Eun-Hye;Jang, Min-Gee;Hwang, Ji-Hoo;Lee, Seung-Hoon;Jeong, Won-Je;Lee, Jae-Dong;Lee, Seung-Deok;Kim, Kyung-Ho;Kim, Kap-Sung;Kim, Eun-Jung
    • Journal of Acupuncture Research
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    • v.27 no.4
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    • pp.195-202
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    • 2010
  • Objectives : This study was performed to report adverse events in Ojeok-san extract powders RCT. Methods : 180 patients with LBP were randomized into groups for a double blind, placebo-controlled clinical study. They received Ojeok-san simple Extract, Ojeok-san complex Extract or placebo in powders, orally dissolved 3times a day for 4weeks. During 4weeks, we researched the symptoms and duration of adverse events and Digest ability, Milk hypersensitivity, Starch hypersensitivity, Caramel hypersensitivity, West-med hypersensitivity, Herb-med hypersensitivity in patients who had adverse events. Results : 52patients(28.9%) had adverse events and of them 44patients(28.9%) had lost adverse events naturally. But 5patients(2.8%) were withdrawn from the research because of the adverse events. Most of the symptoms of adverse event was Gastrointestinal symptom(88.3%) and adverse events frequency was not different from Ojeok-san simple Extract, Ojeok-san complex Extract and placebo. Conclusions : Ojeok-san extract powders had adverse events no different from the placebo, which shows that it is a safe drug.

Effects of Copper Reduction on Angiogenesis-Related Factors in Recurrent Glioblastoma Cases

  • Jazayeri, Shima;Feli, Alireza;Bitaraf, Mohammad Ali;Dodaran, Masoud Solaymani;Alikhani, Mazdak;Hosseinzadeh-Attar, Mohammad Javad
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.10
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    • pp.4609-4614
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    • 2016
  • Purpose: To evaluate the therapeutic effects of copper reduction on angiogenesis-related factors in patients with glioblastoma multiforme treated by gamma knife radiosurgery. Materials and Methods: In the present block randomized, placebo-controlled trial, fifty eligible patients with a diagnosis of glioblastoma multiforme who were candidates for gamma knife radiosurgery were randomly assigned into two groups to receive daily either 1gr penicillamine and a low copper diet or placebo for three months. The intervention started on the same day as gamma knife radiosurgery. Serum interleukin-6 (IL-6), tumor necrosis $factor-{\alpha}$ ($TNF-{\alpha}$), vascular endothelial growth factor (VEGF) and copper levels were measured at baseline and after the intervention. The serum copper level was used as the final index of compliance with the diet. In order to control probable side effects of intervention, laboratory tests were conducted at the beginning, middle and end of the study. Results: The patients had a mean age and Karnofsky Performance Scale of 43.7 years and 75 respectively. Mean serum copper levels were significantly reduced in intervention group. Mean survival time was 18.5 months in intervention group vs. 14.9 in placebo group. VEGF and IL-6 levels in the intervention group were also significantly reduced compared to the placebo group and $TNF-{\alpha}$ increased less. Conclusions: It seems that reducing the level of copper in the diet and dosing with penicillamine leads to decline of angiogenesis-related factors such as VEGF, IL-6 and $TNF-{\alpha}$. Approaches targeting angiogenesis may improve survival and can be used as a future therapeutic strategy.