• Title/Summary/Keyword: Pilot trial

Search Result 164, Processing Time 0.035 seconds

Clinical Research of Warm Needle Acupuncture for Chronic Low Back Pain: A Protocol for Randomized, Controlled Pilot Study (온침이 만성요통에 미치는 효과에 대한 무작위배정 대조군 예비 임상연구 프로토콜)

  • Seo, Yeonho;Kim, Taeoh;Cho, Whisung;Ko, Junhyuk;Ahn, Jonghyun;Kim, Soo Jeon;Lee, Hansol;Chang, Hokyung;Kim, Hyungsuk;Kim, Koh-Woon;Cho, Jae-Heung;Chung, Wonseok;Song, Mi-Yeon
    • Journal of Korean Medicine Rehabilitation
    • /
    • v.30 no.4
    • /
    • pp.155-164
    • /
    • 2020
  • Objectives This study is aimed to evaluate the feasibility of further clinical research of warm needle acupuncture as an effective and safe treatment for chronic low back pain. Methods Thirty participants will be randomly assigned to the Warm needle acupuncture group (n=15) and Dry needle acupuncture group (n=15). All patients will receive acupuncture therapy twice a week for 6 weeks, but only the experimental group will receive thermal stimulation. The primary outcome will be measured using the visual analogue scale for bothersomeness of low back pain, and the secondary outcome will be measured using the VAS for pain intensity, Oswestry disability index, 36-Item Short Form Health Survey, Beck's depression inventory, and amount of analgesics used. Conclusions The results of this study will be used to determine the feasibility of a future large-scale randomized controlled trial that provides clinical evidence for the efficacy and safety of warm needle acupuncture in the treatment of patients with chronic low back pain.

The Effects of Electroacupuncture for Treatment of Patients with Non-Alcoholic Fatty Liver Disease: Prospective Randomized Controlled Study (알코올성 지방간 환자에 있어 전침 치료의 효과: 무작위 배정 대조군 연구)

  • Lee, Chang-Hyeong;Kim, Byung-Seok;Choi, Ae-Ryun;Kim, Kyung-Soon;Kwak, Min-A;Kim, Seung-Mo
    • Journal of Korean Medicine for Obesity Research
    • /
    • v.15 no.1
    • /
    • pp.1-8
    • /
    • 2015
  • Objectives: The aim of this study was to evaluate the effectiveness and safety of electroacupuncture for non-alcoholic fatty liver disease (NAFLD). Methods: A randomized, controlled pilot trial was conducted. Twenty-two participants were randomized into one of the two groups: an acupuncture group (n=11) and wait-list group (n=11). The treatment group received 8 sessions of electroacupuncture over 8 weeks. Twenty points (CV4, CV12, both LR14, GB26, ST25, ST34, ST40, ST36, SP4, SP6, LR3) were selected for needling. The control group did not receive acupuncture treatment during study period and followup were done in the 4th and 8th weeks after randomization in both groups. The primary outcome was body fat computed tomography and the secondary outcomes included blood test (aspartate aminotransferase, alanine transferase, triglyceride, total cholesterol, high density lipoproteincholesterol, low density lipoprotein-cholesterol, blood sugar test, ${\gamma}$-guanosine triphosphate) and body composition test (body mass index, weight, body fat mass, body fat rate, waist hip ratio). Safety was assessed at every visit. Results: There was no significant differences in between the experimental group and control group. There were no adverse events. Conclusions: The results suggest that In patients with NAFLD, electroacupuncture treatment did not induce worsening of liver disease and liver function, but it was no improvement symptoms of fatty liver. Study of herb medicine treatments and other acupuncture therapy of NAFLD are required later.

An Investigation on the Effects of Wet Cupping on Wisu (BL21) for Non-acute Low Back Pain: A Pilot Randomized Controlled Trial (비급성 요통에 대한 위수혈 자락관법의 효과 탐색: 예비 무작위 대조군 시험)

  • Kim, Hyungsuk;Cho, Jae-Heung;Kim, Koh-Woon;Chung, Won-Seok;Park, Jae-Hyun;Shin, Woo-Chul;Chung, Seok-Hee
    • Journal of Korean Medicine Rehabilitation
    • /
    • v.28 no.4
    • /
    • pp.21-32
    • /
    • 2018
  • Objectives This study was designed to investigate the effects of wet cupping on Wisu (BL12) in non-acute low back pain patients. Methods We recruited 30 participants for this study. Fifteen patients were randomly assigned to the Wisu (BL21) treatment group (WT group) and 15 were assigned to the non-acupoint treatment group (NT group). Both groups were treated with the pricking-cupping bloodletting method three times. Values at baseline and follow-up were analyzed by Wilcoxon signed rank test and the differences between the two groups were determined by Wilcoxon rank sum test. p-values less than 0.05 were considered significant. The primary outcome was the visual analogue scale (VAS), and secondary outcomes were the Oswestry disability index (ODI), Rolland-Morris disability questionnaire (RMDQ), Euroqol-5 dimension questionnaire (EQ-5D) and finger-to-ground distance (FTGD). These outcomes were measured on the day of first treatment before the procedure and on follow-up 7 days after the last treatment. Results Significant changes were identified in the VAS for pain and ODI in each group after wet cupping treatment on Wisu (p<0.05). However, no significant changes were found between groups. Meanwhile, RMDQ and EQ-5D were significantly decreased only in the NT group (p<0.05) without any differences between groups. FTGD was decreased in both groups, but not significantly. Conclusions Wet cupping with both Wisu treatment and non-acupoint had significant effects on non-acute low back pain, although there were no differences between the two groups. A large-scale study is needed to identify the effect of wet cupping on Wisu.

Case study on Dental Hygiene Care Program with the Focus on Non-surgical Periodontal Treatments with the Maternal and Child Health Center (일부 보건소 모자보건실 연계 비외과적 치주처치 중심의 치위생관리 프로그램 운영 사례연구)

  • Son, Jung-Hui;Kim, Sang-hee;Bae, Soo-Myoung
    • The Journal of the Korea Contents Association
    • /
    • v.19 no.2
    • /
    • pp.269-276
    • /
    • 2019
  • This research was conducted by targeting pregnant women in the trial operation of dental hygiene care program with the focus on non-surgical periodontal treatments at the Maternal and Child Health center in the public health center. This study was conducted to provide basic data to dental hygienists who operate oral health promotion programs by targeting pregnant women of the local community through the evaluation on structure, the assessment process and results from the pilot program at the public health center. The targets are nine pregnant women who have been involved in the Dental hygiene care program three times. An evaluation on the structure, process and results according to the Indicators of each program were conducted. The results of dental hygiene care program found that the retention rate decreased. The retention of the probing pocket depth larger than 4mm was 40.4% to 14.0%(p<0.05). The retention rate of the gingival bleeding teeth was 4.6% to 2.7% (p=0.180). PHP Index improved. 1.7 points in the 1st to 1.4 points in the 3rd in the case of the second pregnant woman and 2.4 points in the 1st to 1.3 points (p<0.05) in the 3rd in the case of the third pregnant woman. The applicable and expandable possibility of the dental hygiene care program with the focus on non-surgical periodontal treatments at the Community Health Center is significant in the result of this study. In the future, long-term operation and ongoing monitoring of this program is needed.

Hospital Workers' Awareness and Attitude Towards Medical Records and OpenNotes (진료기록과 오픈노트(Open Notes)에 대한 병원 종사자들의 인식과 태도)

  • Choi, Ju-Hee;Seol, Hee Yun;Kim, Sung-Soo
    • The Journal of the Korea Contents Association
    • /
    • v.20 no.12
    • /
    • pp.635-645
    • /
    • 2020
  • An "OpenNote" can be defined as the sharing of medical records between patient and doctors by online, and is a new trial to allow patients to access their medical records any time. To identify the need for the introduction of OpenNotes, which is expanding medical recrods, this study has researched the awareness and attitude towards medical records and OpenNotes among hospital workers in charge of part of medical servises. One of the results in this study is that recognizing his or her own records can impact his or her understanding his or her health status. Also, the subjects who were participated in this study generally agreed with the usefulness of the OpenNote and were willing to participate in the OpenNote. Meanwhile the subjects are admitting counterfeiting the medical records or falsifying them. The conclusion has been shown that patient-doctor sharing of medical records could help patients better understand their health information and encourage their self-care. When patients can access their own medical records easily, Unnecessary misunderstandings and distrust of records between patients and medical staff can be markedly reduced then it can help to build up the trust in a doctor-patient relationship. Considering not only the health utility of OpenNotes but also the impact on the trust of doctors, the pilot project of OpneNotes for experimental verification is proposed.

Effect of Joint Mobilization and Insole on Pain, Pelvic Angle, and Foot Pressure in Patient with Sacroiliac Joint Pain : A Randomized Controlled Pilot Trial (관절가동술과 깔창적용이 엉치엉덩관절통증환자의 통증과 골반경사각, 족저압에 미치는 효과: 무작위배정예비임상시험)

  • Lim, Chae-Gil
    • Journal of Korea Entertainment Industry Association
    • /
    • v.14 no.3
    • /
    • pp.383-392
    • /
    • 2020
  • This study was to compare the effects of joint mobilization, treadmill with insole, and joint mobilization and treadmill with insole on pain, pelvic angle, and foot pressure in patients with sacroiliac joint pain. 24 patients randomly assigned to joint mobilization group(n=8), treadmill with insole group(n=8), or joint mobilization and treadmill with insole group(n=8). Each groups were conducted 30 minutes a day, two days a week for four weeks. Pain was evaluated using visual analogue scale and pelvic angle was measured using palpation meter and foot pressure(fore/rear ratio) was measured using Gateview AFA-50 before intervention and after 4 weeks. All groups were significant differences pain in intragroup(p<.01). In pelvic angle, the joint mobilization group was statistically significant in the anterior tilt only, the joint mobilization and treadmill with insole group showed statistically significant improvement in both anterior and posterior tilt(p<.01), and the treadmill with insole group did not show any statistically significant change(p>.05). Also the joint mobilization and treadmill with insole group were significant differences in foot pressure(p<.01). All the interventions reduce sacroiliac joint pain and joint mobilization and treadmill with insole training are most effective changes in pelvic angle and foot pressure. This study can be used as a basic data for prevention of injury, posture correction and gait training in patients with sacroiliac joint pain, as well as chronic low back pain and plantar pressure problem.

The Present Clinical Studies of Oriental Medicine and CAM Therapies in Chemotherapy-induced Peripheral Neurotoxicity (항암제 유발 신경독성을 관리하는 한의학 및 보완대체요법들과 임상시험 현황)

  • Park, Sun-Ju;Go, Ho-Yeon;Han, Yoo-Jin;Ko, Seong-Gyu;Kim, Sung-Hoon
    • The Korea Journal of Herbology
    • /
    • v.24 no.4
    • /
    • pp.205-213
    • /
    • 2009
  • Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

Effect of diabetes-specific oral nutritional supplements with allulose on weight and glycemic profiles in overweight or obese type 2 diabetic patients

  • Jihye Tak;Minkyung Bok;Hyunkyung Rho;Ju Hyun Park;Yunsook Lim;Suk Chon;Hyunjung Lim
    • Nutrition Research and Practice
    • /
    • v.17 no.2
    • /
    • pp.241-256
    • /
    • 2023
  • BACKGROUND/OBJECTIVES: Diabetes-specific oral nutritional supplements (ONS) have anti-hyperglycemic effects, while D-allulose exerts anti-diabetic and anti-obesity effects. In this study, we investigated the efficacy and safety of diabetes-specific ONS, including allulose, on glycemic and weight changes in overweight or obese patients with type 2 diabetes mellitus (T2DM). SUBJECTS/METHODS: A single-arm, historical-control pilot clinical trial was conducted on 26 overweight or obese patients with T2DM (age range: 30-70 yrs). The participants were administered 2 packs of diabetes-specific ONS, including allulose (200 kcal/200 mL), every morning for 8 weeks. The glycemic profiles, obesity-related parameters, and lipid profiles were assessed to evaluate the efficacy of ONS. RESULTS: After 8 weeks, fasting blood glucose (FBG) level significantly decreased from 139.00 ± 29.66 mg/dL to 126.08 ± 32.00 mg/dL (P = 0.007) and glycosylated hemoglobin (HbA1c) improved (7.23 ± 0.82% vs. 7.03 ± 0.69%, P = 0.041). Moreover, the fasting insulin (δ: -1.81 ± 3.61 μU/mL, P = 0.017) and homeostasis model assessment for insulin resistance (HOMA-IR) (δ: -0.87 ± 1.57, P = 0.009) levels decreased at 8 weeks, and body weight significantly decreased from 67.20 ± 8.29 kg to 66.43 ± 8.12 kg (P = 0.008). Body mass index (BMI) also decreased in accordance with this (from 25.59 ± 1.82 kg/m2 to 25.30 ± 1.86 kg/m2, P = 0.009), as did waist circumference (δ: -1.31 ± 2.04 cm, P = 0.003). CONCLUSIONS: The consumption of diabetes-specific ONS with allulose in overweight or obese patients with T2DM improved glycemic profiles, such as FBG, HbA1c, and HOMA-IR, and reduced body weight and BMI.

THE PREVALENCE OF WHITE SPOT LESIONS ON THE MESIAL SURFACES OF THE 1ST MOLARS IN CHILDREN AND MINIMAL INVASIVE APPROACH - A PILOT STUDY (어린이 제1대구치 근심면 초기 우식의 유병률과 최소 침습적 접근)

  • Ahn, Myung-Ki;Lee, Geum-Lang;Jeong, Tae-Sung;Kim, Shin
    • Journal of the korean academy of Pediatric Dentistry
    • /
    • v.36 no.1
    • /
    • pp.102-107
    • /
    • 2009
  • In clinical pediatric dentistry, we have many chances to encounter the white spot like incipient enamel lesions on the mesial surfaces of the 1st molars with direct vision, especially just after the 2nd primary molars were exfoliated. But it was thought highly desirable to assess if these lesions are properly and effectively managed yet. This study aims at surveying the prevalence of incipient lesions on the mesial surfaces of the 1st molars in children through direct observation and examining the suitability of adhesive sealing on them as a pilot trial in searching for their proper management. 1. Among the 124 mesial surfaces of the 1st molars examined, 34% were sound, 53% had incipient carious lesions and 13% had cavitated lesions. 2. In the sectional views of the specimens, 20% showed microleakage after thermo-cycling and it was thought not recommendable as a permanent method. Therefore in order to effectively fight against the incipient caries lesions in children‘s permanent teeth, it was thought proper not to rely on any one method, but to perform reinforcing oral hygiene and promotion of remineralization in combination with therapeutic sealing which is stronger in short-term sealing effect. Although therapeutic sealing has been considered as the core in minimally invasive concept to treat the white spot lesions, its long-term clinical trials have not been suggested. Continuous research is strongly required for making this approach to acquire permanent nature, especially in regards of proper pretreatment and high molecular materials deeply penetrable into enamel.

  • PDF

A Pilot Study of Evaluating the Reliability and Validity of Pattern Identification Tool for Insomnia and Analyzing Correlation with Psychological Tests (불면증 변증도구 신뢰도와 타당도 평가 및 심리검사와의 상관성에 대한 초기연구)

  • Jeong, Jin-Hyung;Lee, Ji-Yoon;Kim, Ju-Yeon;Kim, Si-Yeon;Kang, Wee-Chang;Lim, Jung Hwa;Kim, Bo Kyung;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
    • /
    • v.31 no.1
    • /
    • pp.1-12
    • /
    • 2020
  • Objectives: The purpose of this study was to evaluate the reliability and validity of the instrument on pattern identification for insomnia (PIT-Insomnia) and verify the correlation between PIT-Insomnia and psychological tests. Methods: Two evaluators examined the pattern identification of the participants who met insomnia disorder diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) and took the Insomnia Severity Index (ISI) score over 15 once manually and twice using the PIT-Insomnia to measure the inter-rater and test-retest reliability. We also conducted the following surveys: the Pittsburgh Sleep Quality Index (PSQI), the Korean version of Beck's depression inventory (K-BDI), the Korean version of the State-Trait Anxiety Inventory (STAI-K), the Korean Symptom checklist-95 (KSCL-95), and the EuroQol-5 dimension (EQ-5D), to measure concurrent validity and correlation between the PTI-Insomnia and psychological tests. Results: 1. The test-retest reliability analysis of the pattern identification results showed moderate agreement, and test-retest reliability analysis of each pattern identification score showed agreements from poor to moderate. 2. The inter-rater reliability analysis of the pattern identification results via manual showed slight agreement, when analysis was performed with calibration, the inter-rater reliability analysis of the pattern identification results via manual showed fair agreement. 3. The concordance analysis between results via manual and the PIT-Insomnia showed poor agreement, when the analysis was performed with calibration, concordance analysis showed fair agreement. 4. The concordance analysis between the PIT-Insomnia and the PSQI showed positive linear correlation. 5. The concordance analysis between the PIT-Insomnia and the PSQI, K-BDI, STAI-K, KSCL-95, and EQ-5D showed that non-interaction between the heart and kidney have positive linear correlation with the K-BDI, anxiety item of KSCL-95, dual deficiency of the heart-spleen have positive linear correlation with somatization item of KSCL-95, paranoia item of KSCL-95, heart deficiency with timidity have positive linear correlation with stress vulnerability item of KSCL-95, parania item of KSCL-95, phlegm-fire harassing the heart have positive linear correlation with K-BDI, paranoia item of KSCL-95, depressed liver qi transforming into fire have positive linear correlation with the anxiety item of KSCL-95, parania item of KSCL-95, all pattern identification have negative linear correlation with EQ-5D. Conclusions: The PIT-Insomnia has moderate agreement of reliability and reflects the severity of insomnia since it has some concurrent validity with the PSQI. There are some correlations between the PTI-Insomnia with specific psychological tests, so we could suggest it can be used appropriately in the clinical situation.