• Title/Summary/Keyword: Prospective randomized trial

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Preliminary Study on Effectiveness of Dexamethasone-Soaked Gelatin Sponges for Reducing Pain after Lumbar Microdiscectomy : A Randomized Controlled Trial

  • Shin, Dong-Ah;Gong, Tae-Sik;Shin, Dong-Gyu;Kwon, Chang-Young;Kim, Hyoung-Ihl
    • Journal of Korean Neurosurgical Society
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    • v.39 no.1
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    • pp.11-15
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    • 2006
  • Objective : A prospective, randomized, controlled clinical study is performed to verify the effectiveness of epidural dexamethasone-soaked gelatin sponges to reduce postoperative pain following lumbar microdiscectomy. Methods : Twenty-three patients (10 men and 13 women) undergoing lumbar microdiscectomy were included. Five pieces of gelatin sponge measuring $1{\times}1cm$ [Gelfoam; Pharmacia & Upjohn. Kalamazoo, MI, USA], soaked with either 5mg dexamethasone or an equal amount [2mL] of saline, were left on the decompressed nerve root after unilateral hemilami-nectomy, flavectomy and discectomy. Results : Subjective visual analog scale[VAS] scores of leg pain in the dexamethasone group on the first, third and first postoperative days [2.5, 2.5, 1.7, respectively] were significantly lower than in the control group [5.0, 4.8, 3.6][P<0.05]. No side effects related to the dexamethasone-soaked gelatin sponges were observed. Conclusion : The intraoperative application of dexamethasone-soaked gelatin sponges during lumber microdiscetomy can provide effective-postoperative analgesia without complications.

A Systematic Review from the Journals under the Korean Oriental Medical Society (대한한의학회지 및 대한한의학회 산하 정회원 학회의 학술진흥재단 등재지에 대한 비염 임상연구의 체계적 고찰)

  • Lee, Kyu-Sun;Park, Dong-Hee;Kim, Gae-Eun;Bang, Ji-Hyun;Kim, Jae-Hwan;Choi, Joon-Yong;Jung, Hee-Jae;Jung, Sung-Ki
    • The Journal of Korean Medicine
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    • v.31 no.5
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    • pp.1-11
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    • 2010
  • Objectives: This study aimed to evaluate any clinical studies regarding rhinitis published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to rhinitis was initially obtained from journals of the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 36 initially obtained articles, 17 were finally analyzed. 2 articles were randomized controlled studies, 6 articles were prospective whereas 9 were retrospective. In the prospective articles, there were no randomized controlled trials and the other non-randomized studies had no control group with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described rhinitis diagnosis objectively and outcome measures were either non-relevant to rhinitis or non-validated. Conclusions: Further well-designed randomized controlled studies for rhinitis are mandatory and more rigorous non-randomized controlled studies should be conducted.

Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture

  • Lee, Jeong-Yol;Kim, Min-Soo;Kim, Ha-Young;Shin, Sang-Wan
    • The Journal of Advanced Prosthodontics
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    • v.5 no.2
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    • pp.204-208
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    • 2013
  • PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.

Comparing Conventional Suture Method Versus Wound Closure Using Tissue Glue(Histoacryl Blue®): a Prospective Randomized Clinical Trial (기존의 창상봉합과 Histoacryl Blue®를 이용한 창상봉합의 비교 분석: 전향적 무작위 임상실험)

  • Choi, Jong Woo;Hyun, Kyung Bae;Kim, Yong Oock;Park, Beyoung Yun
    • Archives of Plastic Surgery
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    • v.32 no.1
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    • pp.19-23
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    • 2005
  • Tissue adhesives have gained popularity for quicker and painless closure of lacerations. The use of tissue glue is currently popular for the closure of superficial lacerations, especially in children. Histoacryl $Blue^{(R)}$(2-N-butylcyanoacrylate) is a topical wound closure that precludes the need for foreign bodies to close wounds. The purpose of this study was to compare the applications of Histoacryl $Blue^{(R)}$(HAB) and conventional suture, regarding cosmetic outcome. To compare the short term and long term results of various repair methods, we designed the prospective, randomized, blind study. Patients with laceration undergoing repair were randomly allocated to conventional suture, subcutaneous suture plus HAB, and HAB only groups. The exclusion criterions were large wound that require large tension for repair or avulsion wound. An independent, blinded observer assessed cosmetic result at 7-10 days after repair and 3-9 months postoperatively. Physician's satisfaction with wound appearance was recorded on 100 mm Visual Analogue Scale(VAS)(0=worst, 100=best). The difference in VAS score between conventional suture method and subcutaneous suture plus HAB methods were not significant. Tissue glue being easy to use with no complications and still resulting in equivalent cosmetic outcomes has several benefits. Especially in the case of children, the wound closure with Histoacryl $Blue^{(R)}$ could be a good alternative for repair of laceration in emergency room.

Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical trial

  • Gomes, Aline Cristine;Soares, Adriana Jesus;Souza, Erick M;Zaia, Alexandre Augusto;Silva, Emmanuel Joao Nogueira Leal
    • Restorative Dentistry and Endodontics
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    • v.42 no.2
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    • pp.140-145
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    • 2017
  • Objectives: The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo) or single-file reciprocating (Reciproc) systems were used. Materials and Methods: Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS), ranging from 'least possible discomfort' (1) to 'greatest possible discomfort' (10). The Wilcoxon signed-rank test was used to determine significant differences at p < 0.05. Results: Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660). Conclusions: Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

Association of Trial Registration with Reporting Biases in Randomized Controlled Trials of Acupuncture (침 무작위 대조 임상 시험에서 보고 비뚤림과 프로토콜 등록 여부의 관련성 연구)

  • Kim, Seoyeon;Won, Jiyoon;Park, Hi-Joon;Lee, Hyangsook
    • Korean Journal of Acupuncture
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    • v.35 no.2
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    • pp.70-81
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    • 2018
  • Objectives : To investigate the association of trial registration status with presence of reporting bias including publication bias and outcome reporting bias in recently published randomized controlled trials (RCTs) of acupuncture. Methods : A PubMed search for RCTs of acupuncture published from March 2016 to February 2017 was conducted. Primary outcomes were identified and the direction of the results was judged as positive (i.e., statistically significant) or negative. The trial registration was identified by manually screening the trial registration number in the main text of the published article and classified into 1) prospective registration; 2) retrospective registration based on the registration date or; 3) no registration. Results : Of the 125 included RCTs, only 40 studies (32.0%) prospectively registered the study protocols. Among 65 RCTs that adequately reported the primary outcome, unregistered trials were more likely to report positive results than the registered ones (p=0.013). Of the 40 prospectively registered studies, 19 trials (47.5%) had the discrepancies between the registered and published primary outcomes and furthermore, 40% of them reported the positive findings. Conclusions : Unregistered trials were more likely to report positive results and the discrepancies between the registered and published primary outcomes were detected in about a half of the prospectively registered studies, 42.1% of which tended to report positive findings. Journal editors and researchers in this field should be alerted to various reporting biases.

A Prospective Randomized Trial Comparing Manual Needle Aspiration to Closed Thoracostomy as an Initial Treatment for the First Episode of Primary Spontaneous Pneumothorax

  • Kim, In Ha;Kang, Do Kyun;Min, Ho-Ki;Hwang, Youn-Ho
    • Journal of Chest Surgery
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    • v.52 no.2
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    • pp.85-90
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    • 2019
  • Background: Variation exists in the initial treatment for the first episode of primary spontaneous pneumothorax (PSP), and no definitive consensus exists due to a lack of high-quality evidence. This study examined the outcomes of needle aspiration and closed thoracostomy in first episodes of PSP requiring intervention. Methods: This study was a randomized, prospective, single-center trial conducted between December 2015 and August 2016. Patients of all ages with a documented first episode of PSP who were unilaterally affected, hemodynamically stable, and had a pneumothorax measuring over 25% in size were included. Patients with underlying lung disease, severe comorbidities, bilateral pneumothorax, tension pneumothorax, recurrent pneumothorax, traumatic pneumothorax, and pregnancy were excluded. Patients were randomly assigned to the needle aspiration or closed thoracostomy group using a random number table. Results: Forty patients with a first episode of PSP were recruited, and 21 and 19 patients were included in the needle aspiration group and the closed thoracostomy group, respectively. The hospital stay of each group was $2.1{\pm}1.8days$ and $5.4{\pm}3.6days$, respectively (p<0.01). However, no significant differences were found in the success rate of initial treatment or the 1-month and 1-year recurrence rates. Conclusion: Needle aspiration is a favorable initial treatment in patients experiencing a first episode of PSP.

The Trends in Clinical Trials about Effects of Acupuncture on Anxiety, Depression and Mental Stress - In Medline, Pubmedcentral & Oriental Medicine Journal since 2004 - (침치료가 불안, 우울 및 정신적 스트레스에 미치는 효과에 대한 임상시험 연구 경향 - 2004년 이후의 Medline, Pubmedcentral 논문 검색과 국내 한의학 학술지 중심으로 -)

  • Kang, Hee-Chul;Lee, Seung-Gi
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.4
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    • pp.137-148
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    • 2009
  • Objectives : The purpose of this study is to review the recent trends in the clinical trial studies that have been published since 2004. Methods : We reviewed the Medline & Pubmedcentral databases by using searching word of "acupuncture". Then 20 articles were selected within total 803 articles. In oriental medicine journals in Korea, we investigated 6 journals represented Korean Oriental medicine and chose 13 articles. Results & Conclusions : 1. We found 33 articles in journals. 2. The patterns of study were as follows: Randomized Controlled Trials(18), Single case series clinical study(9), Case-Control clinical study(4), Randomized crossover Trial(1) and Prospective Clinical analysis(1). 3. The fields of study were as follows: Combined anxiety, depression & other psychiatic symptoms(18), Stress & heart rate variablity(5), The single study of anxiety(5), The single study of depression(3), Stress & pupil variablity(1), Stress and heart rate & pupil variablity(1). 4. The methods of acupuncture were as follows: Acupuncture on points of 14 meridians(24), Auricular acupuncture(3), Electro acupuncture(2) and Both Auricular & Electro acupuncture(1). 5. Stomach meridian(足陽明胃經) and ST36(足三里) were used mostly.

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A Randomised, Placebo-controlled Trial of the Effects of Preoperative Pregabalin on Pain Intensity and Opioid Consumption following Lumbar Discectomy

  • Hegarty, Dominic A.;Shorten, George D.
    • The Korean Journal of Pain
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    • v.24 no.1
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    • pp.22-30
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    • 2011
  • Background: Pregabalin has been shown to have analgesic effect in acute pain models. The primary objective was to examine the efficacy a single dose of pregabalin, would have on morphine consumption following lumbar discectomy. Methods: With ethical approval a randomized, placebo-controlled prospective trial was undertaken in 32 patients (ASA I-II, 18-65 years) with radicular low back pain for > 3 months undergoing elective lumbar discectomy. Patients received either oral pregabalin 300 mg (PG Group) or placebo (C Group) one hour before surgery. Pain intensity, the accumulative morphine consumption and adverse effects were recorded for 24 hours following surgery. Functional, psychological and quantitative sensory testing were also assessed. Results: Fourteen patients out of the 32 recruited were randomized to receive pregabalin. Morphine consumption was reduced (absolute difference of 42.3%) between groups with medium effect size. (Mann-Whitney; U =52.5, z-score= 2.84, P = 0.004, r = 0.14). This was not associated with a significant difference in the incidence of adverse effects between the two groups. The median pain intensity (VAS) on movement was not significantly different between groups. Conclusions: A single pre-operative dose of pregabalin (300 mg) did not result in a reduction in pain intensity compared to placebo in this patient cohort but the significant reduction in morphine consumption suggests that a fixed peri-operative dosing regime warrants investigation.