• Title/Summary/Keyword: Pilot trial

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Prevention Effects of Graduated Compression Stockings and Intermittent Pneumatic Compression on Deep Vein Thrombosis in SICU Patients: Pilot Study (항혈전스타킹과 간헐적공기압박기 적용이 중환자의 심부정맥혈전 발생 예방에 미치는 효과: 예비조사)

  • Kim, Hwasoon;Cho, Ok Min;Kim, Ji Sun;Jang, Hai Ok;Kim, Yeo Kyeong;Kim, Seol Hee;Min, Hyo Nam;Kwak, Kyung Sun;Hong, Kee Chun;Kim, Jang Yong;Chung, Joonho
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.22 no.3
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    • pp.249-257
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    • 2015
  • Purpose: The purpose of this pilot study was to investigate the effects of mechanical interventions for deep vein thrombosis (DVT) prophylaxis in surgical intensive care unit (SICU) patients. Methods: The participants were assigned to the intermittent pneumatic compression (IPC) and graduated compression stocking (GCS) intervention. Patients who met the criteria were selected for comparison from our previous study. Data for 140 patients were included in the final analysis. Results: The mean age was 57.5 (${\pm}15.7$) and 61.4 % were men. About forty-seven percent of the participants were 61 years or over. In the second duplex scan, 3, 2 and 1 critically ill patients developed deep vein thrombosis in the control, GCS, and IPC groups, respectively. Incidences of DVT were 6.0%, 5.0%, and 2.0% for the control, GCS, and IPC groups, respectively. This difference was not significant. Relative risks of no intervention were 3.0 and 1.2 compared with IPC and GCS application. There were no significantly different variables among the three groups before the intervention except for diagnosis on admission. Conclusion: Although it may difficult to conclude that mechanical prophylaxis effectively prevents DVT among SICU patients because there was no statistical significance in this study, but incidence rates among the three groups differed greatly. The findings reveal that further study should be conducted with larger samples and randomized controlled trial for SICU patients.

Evaluating the Effectiveness of Chuna Manual Therapy for low back pain in the Pilot Insuring Project of the National Health Insurance (건강보험 시범사업 기관에 내원한 요통환자에 대한 추나요법 유효성 평가 연구)

  • Ryu, Jiseon;Kim, Dongsu;Shin, Byung-Cheul;Lim, Byungmook
    • Journal of Society of Preventive Korean Medicine
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    • v.22 no.3
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    • pp.1-10
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    • 2018
  • Backgrounds : In 2017, National Health Insurance implemented the pilot insuring project for Chuna manual therapy(CMT). 65 Korean Medicine(KM) hospitals and clinics were selected in the project to monitor the provision of insured CMT. Objectives : This study aimed to evaluate the effectiveness of CMT for low back pain provided in the real world setting. Methods : Patients with low back pain who agreed to participated in the study were enrolled and requested to complete questionnaires. Patients who received CMT regardless of receiving other KM therapies were classified to Chuna group, and patient who received KM therapies without CMT to KM group. Pain(pain-VAS) and back function(KODI, Oswestry disability index-Korean version), quality of life were assessed at baseline, 4 weeks, and 8 weeks. Additionally, patients who received CMT twice and more, and who's pain-VAS 20 and over were included, and patients who used pain injection were excluded in the analysis. Results : Of 371 patients who completed all questionnaire (mean age=42.6years, SD=12.45; 61% female), 96 were excluded, 170 were in Chuna group, and 105 were in KM group. Proportions of patients who had low back pain for more than twelve weeks in the Chuna group and KM group were 57.7% and 24.8%, respectively. Pain and back function were significantly improved on 4weeks and 8weeks in both groups, but there was no difference between two groups. For the patients in the sub-acute and chronic stage(>=12 weeks), change of total KODI scores in the Chuna group was higher than KM group(p=0.013) at 4weeks. Conclusions : CMT with other KM therapies can improve back function in the sub-acute and chronic patients. For insurance policy decision, economic evaluation of CMT is needed.

Adverse Effects of Ma-huang according to Dose : A Randomized Double-Blind Placebo-Controlled Pilot Study (마황용량에 따른 이상반응에 관한 예비연구: 무작위배정이중맹검시험)

  • Hsing, Li-Chang;Lee, Tae-Ho;Son, Dong-Hyug;Yeo, Jin-Ju;Yang, Chang-Sop;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.27 no.1
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    • pp.188-196
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    • 2006
  • Background: Ma-huang (Ephedra sinica) has been widely used to treat respiratory disease in oriental medicine for over a hundred years. Ma-huang preparations contain approximately 1.25% ephedrine alkaloids. Recently, the ephedra alkaloids have received much press lately due to adverse effects in those using whole extracts as 'dietary supplements' for weight loss or athletic performance enhancement, and these reports are troubling given the increasing use of Ma-huang by the general public. The purpose of this report is to determine the proper dosage to minimize adverse effects and maximize the potential curative value. Objectives : The object of this study was to find an effective yet low risk dosage of Ma-huang. Methods : The study was designed as a double-blind randomized placebo-controlled trial. The subjects of this study were 26 adults between 20 to 40 of age who agreed to participate in this study. They were allocated through randomization into three groups. Each group took three opaque capsules three times a day. A group (N=9) took one Ma-huang capsule and two placebo capsules, B group (N=8) took two Ma-huang capsules and one placebo capsule, C group (N=9) took three Ma-huang capsules. The total trial periods was two days. To compare the adverse effects of Ma-huang according to dosage, blood pressure and pulse were checked, and other adverse effects were assessed using a morning questionnaire, patient's global assessment scale and Wong-Baker faces pain rating. Results : The following result were obtained: 1. After taking 18 g of Ma-huang per day, pulse rate had a significant increase. 2. After taking more than 6 g of Ma-huang per day, palpitation would be increased significantly. 3. After taking more than 18 g of Ma-huang per day, tiredness would be increased significantly. Conclusion: According to the results, 12 g of Ma-huang per day will minimize adverse effects and maximize the potential curative value.

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Study Protocol for the Most Effective Recall Method in a Cervical Cancer Screening Program in Klang, Malaysia

  • Rashid, Rima Marhayu Abdul;Dahlui, Maznah
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.10
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    • pp.5867-5870
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    • 2013
  • Background: Cervical cancer is the second most common cancer among Malaysian women with an ASR of 17.9 and a mortality rate of 5.6 per 100,000 population in 2008 (GLOBOCAN, 2008). The 5 year prevalence was estimated to be 14.5 per 100,000 population. As the second most common cancer affecting productive females, cervical cancer imposes an impact to the socioeconomic aspect of the country. However, the poor uptake of cervical cancer screening is a major problem in detecting early pre-cancerous lesions and thus, delay in initiating treatment for cervical cancer. Realizing the urgency to increase the uptake of PAP smear, besides enhancing the promotion of PAP smear screening for women above 35 years old, the call-recall system for pap smear screening had been piloted in one of the suburban districts which aimed to improve regular participation of women for cervical and breast cancer screening. This is of public health importance as identifying the best feasible option to increase patient's respond to participate in the screening program effectively in our setting will be helpful in implementing an organized regular population based screening program tailored to our setting. The pilot program of cervical cancer screening in Klang was an opportunity to assess different options in recalling patients for a repeat pap smear to increase their participation and adherence to the program. Methods and Results: This was a population based randomized control trial. Women aged 20-65 years in the population that matched the inclusion and exclusion criteria were re-called for a repeat smear. There are four different intervention groups; letter, registered letters, short messages services (SMS) and phone calls where 250 subjects were recruited into each group. Samples were generated randomly from the same population in Klang into four different groups. The first group received a recall letter for a repeat smear similar to the one that has been given during the first invitation. The intervention groups were either be given a registered letter, an SMS or a phone call to re-call them. The socio-demographic data of the patients who came for uptake were collected for further analysis. All the groups were followed up after 8 weeks to assess their compliance to the recall. Conclusions: The study will provide recommendations about the most effective methods for recall in a population based pap smear screening program on two outcomes: i) patients response; ii) uptake for repeat pap smear.

Randomized controlled trial to compare oral analgesic requirements and patient satisfaction in using oral non-steroidal anti-inflammatory drugs versus benzydamine hydrochloride oral rinses after mandibular third molar extraction: a pilot study

  • Goswami, Devalina;Jain, Gaurav;Mohod, Mangesh;Baidya, Dalim Kumar;Bhutia, Ongkila;Roychoudhury, Ajoy
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.18 no.1
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    • pp.19-25
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    • 2018
  • Background: Third molar extraction is associated with considerable pain and discomfort, which is mostly managed with oral analgesic medication. We assessed the analgesic effect of benzydamine hydrochloride, a topical analgesic oral rinse, for controlling postoperative pain following third molar extraction. Methods: A randomized controlled trial was conducted in 40 patients divided into two groups, for extraction of fully erupted third molar. Groups A received benzydamine hydrochloride mouthwash and group B received normal saline gargle with oral ibuprofen and paracetamol. Oral ibuprofen and paracetamol was the rescue analgesic drug in group A. Patients were evaluated on the $3^{rd}$ and $7^{th}$ post-operative days (POD) for pain using the visual analogue score (VAS), trismus, total number of analgesics consumed, and satisfaction level of patients. Results: The VAS in groups A and B on POD3 and POD7 was $4.55{\pm}2.54$ and $3.95{\pm}1.8$, and $1.2{\pm}1.64$ and $0.95{\pm}1.14$, respectively and was statistically insignificant. The number of analgesics consumed in groups A and B on POD3 ($5.25{\pm}2.22$ and $6.05{\pm}2.43$) was not statistically different from that consumed on POD7 ($9.15{\pm}5.93$ and $10.65{\pm}6.46$). The p values for trismus on POD3 and POD7 were 0.609 and 0.490, respectively and those for patient satisfaction level on POD3 and POD7 were 0.283 and 0.217, respectively. Conclusions: Benzydamine hydrochloride oral rinses do not significantly reduce intake of oral analgesics and are inadequate for pain relief following mandibular third molar extraction.

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.

A Pilot Study to Assess the Effect of Gami-Jiwhang-Tang on Cognitive Effects in Healthy Children

  • Bahn Geon-Ho;Kim Chang-Ju;Chung Joo-Ho;Kim Yong-Hee;Paik Eun-Kyung;Park Jae-Hyung
    • The Journal of Korean Medicine
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    • v.25 no.4
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    • pp.129-138
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    • 2004
  • Objective : Treatments for patients with mental retardation and pervasive developmental disorders are not curative, and are designed to help those with disabilities adjust to their environments and daily demands. As clinicians, the present authors tried to find agents with potentially curative properties. Among the numerous herbal formulations available, we chose and assessed Gami-jiwhang-tang (GJT) in the hope that it would improve cognitive development of children. Methods : Subjects were typically-developing healthy, 7- to 8-year-old boys and girls living in Seoul, Korea. The experimental group took GJT for six weeks and was followed up six weeks after discontinuation of GJT. The control group was assessed at the same intervals but did not receive placebos. To measure the effects of GJT, neuropsychological tests and intelligence test were taken before commencing GJT and twelve weeks later. Resulets and Conclusion : For all of the ANOVAs, the treatment by time interaction terms was not significant. However, the experimental group showed the tendency to be progressed in most subscales compared with the control group, especially on performance intelligence, visual organization, and verbal fluency. Conclusion : Although GJT failed to reveal significant improvement in cognition, we remain hopeful about the compound and believe that it should be evaluated by a double-blind, placebo-controlled trial in the future.

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Comparison of the Effects of Task-Oriented Circuit Training and Treadmill Training on Walking Function and Quality of Life in Patients With Post-Stroke Hemiparesis: Randomized Controlled Pilot Trial (뇌졸중 환자의 보행기능과 삶의 질에 대한 과제지향적 순환식 보행훈련과 트레드밀 보행 훈련의 효과 비교: 무작위 대조군 예비연구)

  • Youn, Hye-jin;Oh, Duck-won
    • Physical Therapy Korea
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    • v.23 no.2
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    • pp.1-10
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    • 2016
  • Background: Many studies regarding task-oriented training have recently demonstrated functional improvement in patients with post-stroke hemiparesis. The task-oriented approach is very diverse, and chronic stroke patients must have access to a sustained systematic treatment program to enhance their walking ability. Objectives: This study aimed to compare the effects of the task-oriented circuit training and treadmill training on walking function and quality of life in patients with chronic stroke. Methods: Fourteen patients with chronic stroke volunteered for this study. The subjects were randomly divided into a task-oriented circuit training group and a treadmill training group with 7 patients in each. Each training regimen was performed for 30 min a day and 3 days a week for 4 weeks. Assessment tools included the Timed Up-and-Go Test (TUGT), 10-m Walk Test, 6-min Walk Test (6MWT), and the Stroke Impact Scale (SIS). Results: The change in results of the TUGT, 6MWT, and SIS measured prior to and following the training regimens appeared to be significantly different between the two groups (p<.05). In addition, after the intervention, significant differences were found for all parameters in the task-oriented circuit training group and for the TUGT, 6MWT, and SIS in the treadmill training group (p<.05). Conclusion: The findings suggest that task-related circuit training and treadmill training may be helpful to improve walking function and quality of life of patients with post-stroke hemiparesis. Additionally, a task-related circuit training program may achieve more favorable outcomes than a treadmill program.

The effect of whole body vibration training on postural sway in patients with spinal cord injury: a pilot study

  • Asakawa, Yasuyoshi;Lee, Myung-Mo;Song, Chang-Ho
    • Physical Therapy Rehabilitation Science
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    • v.2 no.2
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    • pp.70-74
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    • 2013
  • Objective: The aim of this study was to determine the impact of the application of whole body vibration training (WBV) on the balance ability of patients with an American Spinal Injury Association (ASIA) type C or D spinal cord injury. Design: Randomized controlled trial. Methods: Twelve patients with spinal cord injury were enrolled in this study. The participants were randomized to an experimental group (n=6) or control group (n=6). The subjects in the experimental group received WBV exercise and the control group received the sham exercise without vibration. The vibrations were adjusted vertically to the patient at a 30 Hz frequency and 3 mm amplitude. The whole body vibration lasted for 16 minutes in total including 5-minutes warm-up and cool-down at the beginning and end of the program, respectively. The static sitting balance ability was assessed by measuring the postural sway while sitting on the force plate with the eyes opened or closed. Postural sway length was measured for 30 seconds with a self-selected comfortable position. Results: In the static balance test, the anterio-posterior, medio-lateral, and total postural sway length with the eyes open and closed was improved significantly before and after the intervention in the experimental group (p<0.05). The experimental group showed significantly more improvement than the control group (p<0.05). Conclusions: Our results demonstrated that WBV training has a positive effect on improving static sitting balance and enhanced control of postural sway in patients with an ASIA-C or D type spinal cord injury.

Serum level changes of long chain-polyunsaturated fatty acids in patients undergoing periodontal therapy combined with one year of omega-3 supplementation: a pilot randomized clinical trial

  • Martinez, Gisele Lago;Koury, Josely Correa;Martins, Marcela Anjos;Nogueira, Fernanda;Fischer, Ricardo Guimaraes;Gustafsson, Anders;Figueredo, Carlos Marcelo S.
    • Journal of Periodontal and Implant Science
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    • v.44 no.4
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    • pp.169-177
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    • 2014
  • Purpose: We aimed to investigate the impact of nonsurgical periodontal treatment combined with one-year dietary supplementation with omega (${\omega}$)-3 on the serum levels of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and arachidonic acid (AA). Methods: Fifteen patients with chronic generalized periodontitis were treated with scaling and root planing. The test group consisted of seven patients ($43.1{\pm}6.0$ years) supplemented with ${\omega}$-3, consisting of EPA plus DHA, three capsules, each of 300 mg of ${\omega}$-3 (180-mg EPA/120-mg DHA), for 12 months. The control group was composed of eight patients ($46.1{\pm}11.6$ years) that took a placebo capsule for 12 months. The periodontal examination and the serum levels of DPA, EPA, DHA, and AA were performed at baseline (T0), and 4 (T1), and 12 (T2) months after therapy. Results: In the test group, AA and DPA levels had been reduced significantly at T1 (P<0.05). AA and EPA levels had been increased significantly at T2 (P<0.05). The ${\Delta}EPA$ was significantly higher in the test compared to the placebo group at T2-T0 (P=0.02). The AA/EPA had decreased significantly at T1 and T2 relative to baseline (P<0.05). Conclusions: Nonsurgical periodontal treatment combined with ${\omega}$-3 supplementation significantly increased the EPA levels and decreased the AA/EPA ratio in serum after one year follow-up. However, no effect on the clinical outcome of periodontal therapy was observed.