• Title/Summary/Keyword: Prospective randomized trial

검색결과 155건 처리시간 0.029초

Transcranial direct current stimulation for spinal cord injury-associated neuropathic pain

  • Li, Caixia;Jirachaipitak, Sukunya;Wrigley, Paul;Xu, Hua;Euasobhon, Pramote
    • The Korean Journal of Pain
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    • 제34권2호
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    • pp.156-164
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    • 2021
  • Several types of pain occur following spinal cord injury (SCI); however, neuropathic pain (NP) is one of the most intractable. Invasive and non-invasive brain stimulation techniques have been studied in clinical trials to treat chronic NP following SCI. The evidence for invasive stimulation including motor cortex and deep brain stimulation via the use of implanted electrodes to reduce SCI-related NP remains limited, due to the small scale of existing studies. The lower risk of complications associated with non-invasive stimulation, including transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), provide potentially attractive alternative central neuromodulation techniques. Compared to rTMS, tDCS is technically easier to apply, more affordable, available, and potentially feasible for home use. Accordingly, several new studies have investigated the efficacy of tDCS to treat NP after SCI. In this review, articles relating to the mechanisms, clinical efficacy and safety of tDCS on SCI-related NP were searched from inception to December 2019. Six clinical trials, including five randomized placebo-controlled trials and one prospective controlled trial, were included for evidence specific to the efficacy of tDCS for treating SCI-related NP. The mechanisms of action of tDCS are complex and not fully understood. Several factors including stimulation parameters and individual patient characteristics may affect the efficacy of tDCS intervention. Current evidence to support the efficacy of utilizing tDCS for relieving chronic NP after SCI remains limited. Further strong evidence is needed to confirm the efficacy of tDCS intervention for treating SCI-related NP.

만성 요통 환자에서의 휴대용 저출력 레이저 치료기의 통증 및 기능 효과 (Efficacy of Portable Low Power Laser Therapy on Pain and Functions in Chronic Low Back Pain)

  • 조연욱;김태희;임오경;이주강;박기덕
    • Clinical Pain
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    • 제19권1호
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    • pp.1-7
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    • 2020
  • Objective: A prospective, assessor-blinded, randomized controlled trial was conducted in patients with chronic low back pain to evaluate the efficacy of portable low power laser therapy (LPLT) and the effect when combined with exercise therapy on pain and functions. Method: 60 patients were recruited and 56 patients, excluding 4 dropouts, were randomly allocated to the LPLT group (Group 1: 19 patients), placebo laser therapy with exercise group (Group 2: 18 patients), and LPLT with exercise group (Group 3: 19 patients). Laser therapy and exercise was performed five times a week for 4 weeks. Visual analogue scale (VAS), Schober test, lumbar range of motion (ROM) measures (flexion, extension and lateral flexion), Oswestry Disability index (ODI) were measured at baseline, at 4 weeks after intervention, and at 6 weeks after 2 weeks of no intervention. Results: Statistically significant improvements were noted in all group by time interaction with respect to all outcome parameters (p<0.05). All parameters in each group improved not only in the period of treatment (4 weeks), but also in the final evaluation (6 weeks) 2 weeks after the end of treatment. Post-hoc analysis showed statistically significant difference between the LPLT with exercise group and the other groups in all outcome parameters except for the ODI at 4 weeks and at 6 weeks. Conclusion: Portable LPLT is effective treatment in reducing pain and improving lumbar ROM and with exercise is more effective than laser or exercise monotherapy for the chronic low back pain patients.

Complementary health education and clinical guidance for treating women experiencing infertility along with unexplained resistant hyperprolactinemia

  • Atef M.M. Darwish;Dina A.M. Darwish
    • Journal of Medicine and Life Science
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    • 제20권4호
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    • pp.158-165
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    • 2023
  • This study prospective randomized controlled trial aims to test the impact of adding health education, awareness of some contributing factors and clinical guidance to therapeutic cabergoline given to infertile women with unexplained resistant hyperprolactinemia. It comprised 120 infertile women with unexplained persistent hyperprolactinemia not responding to therapeutic doses of cabergoline 1.5-2 mg/week who were subjected to proper history taking to exclude concomitant drug intake or possible brain problems in all cases. They were classified into group A (60 cases) who received health education and clinical guidance to search for possible contributing factors and were instructed to avoid them in addition to proper therapeutic doses of cabergoline, while group B (60 cases) received proper therapeutic doses of cabergoline only without clinical guidance. After 1 month, serum prolactin (PRL) was measured for all cases. All cases had high PRL level at the start of the study (79.9±28.4 [39-195] and 78.2±19.9 [42-189] in group A and B, respectively) without any significant difference. Pretreatment counselling revealed that lifestyle factors, sexual behaviors or feeding habits may contribute to resistant hyperprolactinemia in all cases without a significant difference between both groups. Serum PRL dropped significantly more in group A (20.14±10.31 [11-45] vs. 49.32±37.03 [12-100]) after combined health education, clinical guidance of the couple and proper treatment. It is concluded that lifestyle factors, sexual behaviors, and feeding habits would affect the response of hyperprolactinemia to treatment. Health education and clinical guidance with some advice to avoid them, would concomitantly improve the response of resistant hyperprolactinemia to therapeutic doses of dopamine agonists.

미세골절술 후 생체막 덮개가 연골 재생에 미치는 영향 : 고식적인 미세골절술과의 전향적 비교 연구 (The Effect of Placing Biomembrane cover following Microfracture on Cartilage Repair: Comparison with Conventional Microfracture Technique in a Prospective Randomized Trial)

  • 손광현;김진호;곽규성;박장원;윤경호;민병현
    • 대한관절경학회지
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    • 제15권2호
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    • pp.83-91
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    • 2011
  • 목적: 슬관절의 연골 결손에 대한 미세골절술 후 병변을 덮는 생체막을 이용한 환자들의 치료 결과를 비교, 분석하고자 한다. 대상 및 방법: 2008년 1월부터 2010년 1월까지 관절경 검사로 확인된 슬관절 연골의 국소적 전층 결손이 있으며, 골관절염을 보이지 않는 53명(총 59례)의 환자를 대상으로 하였다. 무작위로 선정된 36명(42례)은 미세골절술 후 생체막으로 병변을 덮어주었고(실험군), 나머지 17명(17례)은 고식적인 미세골절술만을 시행받았다(대조군). 모든 환자는 수술 후 6개월째에 임상적 결과를 IKDC 설문지와 통증, 만족도에 대한 VAS 점수를 이용하여 비교하였고, 자기공명영상 촬영을 통해 골연골 병변의 회복 상태를 비교하였다. 결과: 임상 결과(IKDC, 통증 VAS, 만족도 VAS)에서 실험군이 대체로 더 우수하였으며 IKDC에서는 두 군 간의 통계적으로 유의한 차이를 보였다. (IKDC, p=0.047, 통증 VAS, p=0.074; 만족도 VAS, p=0.001). MRI 추시결과에서 실험군의 33명(78.6%)에서 우수한 결손 치유(67~100%)를 보이고, 5명(11.9%)만이 불량한 치유 소견을 보인 반면, 대조군에서는 4명(23.5%)의 환자에서 양호한 결손 치유가 관찰되고 9명(52.9%)의 환자들에서 결손 치유가 불량하였다(p=0.001). 실험군에서 35명(83.3%), 대조군 중 6명(35.3%)에서 변연부 결합부에서 간격이 관찰되지 않았다(p=0.001). 생체막 사용과 관련하여 심각한 부작용은 발견되지 않았다. 결론: 슬관절의 연골 결손 병변에 대해 미세골절술 후 생체막으로 도포한 군에서 단기 추시 임상적 결과 및 MRI를 이용한 영상학적 결과에서 결손부의 연골재생이 잘 된 것을 확인하였고, 미세골절술 후 ArtiFilm$^{TM}$을 함께 사용했던 군에서 연골 치유가 더 잘되는 경향이 있음을 시사한다.

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허약노인을 위한 방문재활 프로그램의 장애발생예방 효과에 대한 연구 (Effects of Visiting Prehabilitation Program against Functional Decline in the Frail Elderly: A Prospective Randomized Community Trial)

  • 김창오;이희연;호승희;박현숙;박철우
    • 한국노년학
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    • 제30권4호
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    • pp.1293-1309
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    • 2010
  • 본 연구는 허약노인의 장애발생예방을 위하여 개발된 지역사회 방문재활 프로그램의 효과성을 평가하고, 허약노인 대상의 방문재활사업이 공공부문의 보건기관에서 실제 수행될 수 있도록 그 근거를 마련하는 것을 목적으로 하고 있다. 2009년 4월부터 8월까지 맞춤형 방문건강관리사업에 등록된 저소득 취약계층 노인들 중 110명의 허약노인을 선정하여, 이들을 대상으로 지역사회 중심의 실험연구를 수행하였다. 연구대상자는 무작위 방식으로 실험군(n=50)과 대조군(n=60)으로 나뉘어, 이 중 실험군은 3개월 동안 상·하지 근력강화, 보행능력 강화, 균형능력증진 등에 초점 맞추어진 허약노인 방문재활 프로그램에 참여하게 하였고, 대조군은 가정방문을 통한 낙상예방교육을 받게 하였다. 프로그램의 평가를 위해 1차 결과지표로서 신체기능척도, 간이신체기능 평가를 프로그램 사전·사후에 측정하였고, 그밖에 운동수행능력검사, 영양지표, 정서기능, 입원 및 낙상경험 등을 측정하였다. 연구결과 방문재활 프로그램에 참여한 대상자에서 신체기능척도와 간이신체기능평가 등 주요 노인기능지표의 유의한 향상이 관찰되었다. 신체기능척도에 대해서 실험군은 1.3 ± 3.8점의 상승이 있었던 반면, 대조군에서는 1.1 ± 5.4점의 감소가 있었다 (p=.020). 간이신체기능평가에 대해서도 실험군은 2.4 ± 2.0점의 상승이 있었던 반면, 대조군에서는 0.3 ± 1.5점의 상승만이 관찰되었다 (p<.001). 그밖에 허약노인을 위한 방문재활 프로그램은 운동수행능력, 정서기능, 반복낙상 횟수 및 낙상 후 기능저하 발생에 대해서도 유의한 효과를 보여주었다 (p .002-.038). 향후 우리나라 노인들의 장애발생을 예방하고 이로 인한 중증 장기요양단계로의 진입을 억제하기 위하여 허약노인 대상의 방문재활 프로그램과 이에 근거한 건강관리사업이 보다 적극적으로 확대·보급되어야 할 것이다.

Efficacy and safety of vitamin D3 B.O.N intramuscular injection in Korean adults with vitamin D deficiency

  • Choi, Han Seok;Chung, Yoon-Sok;Choi, Yong Jun;Seo, Da Hea;Lim, Sung-Kil
    • Osteoporosis and Sarcopenia
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    • 제2권4호
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    • pp.228-237
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    • 2016
  • Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

미세 치근단 수술의 성공과 실패 (Success and failure of endodontic microsurgery)

  • 송민주;김의성
    • Restorative Dentistry and Endodontics
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    • 제36권6호
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    • pp.465-476
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    • 2011
  • 최근의 근관치료학 분야에서 외과적 재치료는 수술현미경, 초음파기구, 미세수술기구 등의 도입으로 많은 변화가 있어 왔다. 본 논문에서는 기존의 전통적인 치근단 수술법과 비교하여 미세 치근단 수술의 주요 술식을 알아보고 이미 출간된 논문에 근거하여 미세 치근단 수술의 성공과 실패 그리고 성공과 실패에 영향을 미치는 요소들을 고찰하고자 하였다. 수술현미경은 수술부위를 밝게 확대해서 봄으로써 치근단 부위의 미세한 형태를 조명할 수 있게 되었으며 이는 술식의 성공을 위해서 필수적인 요소가 되었다. 초음파 기구 또한 치근단 역충전을 위한 정확한 와동형성을 가능하게 해 주었다. 따라서 미세 치근단 수술은 기존방식의 문제점이었던 많은 골삭제, 경사진 치근절제, 부정확한 역충전 와동 형성, 치근단 미세구조 관찰의 어려움 등을 극복함으로써 술식이 더욱 정확해지고, 성공가능성이 더 높아졌다고 볼 수 있다. 미세 치근단 수술에 영향을 미치는 요소에는 다양한 요인들이 존재할 수 있으나 전통방식의 치근단 수술보다 술식이 표준화 됨으로써 술식에 의한 영향을 줄일 수 있다. 환자와 치아에 관계되는 요소 중에서는 치주질환의 이환 여부와 치아위치(tooth position)가 예후에 영향을 미치는 것으로 알려져 있으나 이에 대한 연구는 아직까지 그 수가 부족한 상태로 앞으로 검증수준 (evidence level)이 높은 Randomized clinical trial 혹은 전향적 코호트 연구가 많이 이루어져야 할 것이다.

A Simple Dosing Scheme for Intravenous Busulfan Based on Retrospective Population Pharmacokinetic Analysis in Korean Patients

  • Choe, Sang-Min;Kim, Gayeong;Lim, Hyeong-Seok;Cho, Sang-Heon;Ghim, Jong-Lyul;Jung, Jin-Ah;Kim, Un-Jib;Noh, Gyu-Jeong;Bae, Kyun-Seop;Lee, Dong-Ho
    • The Korean Journal of Physiology and Pharmacology
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    • 제16권4호
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    • pp.273-279
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    • 2012
  • Busulfan is an antineoplastic agent with a narrow therapeutic window. A post-hoc population pharmacokinetic analysis of a prospective randomized trial for comparison of four-times daily versus once-daily intravenous busulfan was carried out to search for predictive factors of intravenous busulfan (iBu) pharmacokinetics (PK). In this study the population PK of iBu was characterized to provide suitable dosing recommendations. Patients were randomized to receive iBu, either as 0.8 mg/kg every 6 h or 3.2 mg/kg daily over 4 days prior to hematopoietic stem cell transplantation. In total, 295 busulfan concentrations were analyzed with NONMEM. Actual body weight and sex were significant covariates affecting the PK of iBu. Sixty patients were included in the study (all Korean; 23 women, 37 men; mean [SD] age, 36.5 [10.9] years; weight, 66.5 [11.3] kg). Population estimates for a typical patient weighing 65 kg were: clearance (CL) 7.6 l/h and volume of distribution (Vd) 32.2 l for men and 29.1 L for women. Inter-individual random variabilities of CL and $V_d$ were 16% and 9%. Based on a CL estimate from the final PK model, a simple dosage scheme to achieve the target $AUC_{0-inf}$ (defined as median AUC0-inf with a once-daily dosage) of 26.18 $mg/l{\cdot}hr$, was proposed: $24.79{\cdot}ABW^{0.5}mg$ q24h, where ABW represents the actual body weight in kilograms. The dosing scheme reduced the unexplained interindividual variabilities of CL and Vd of iBu with ABW being a significant covariate affecting clearance of iBU. We propose a new simple dosing scheme for iBu based only on ABW.

단일다발 및 이중다발 전방십자인대 재건술의 전향적 무작위적 비교 연구 (A Prospective Randomized Study of Anterior Cruciate Ligament Reconstruction Comparing Single-Bundle and Double-Bundle Techniques)

  • 박상은;임무준
    • 대한관절경학회지
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    • 제14권1호
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    • pp.13-19
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    • 2010
  • 목적: 전방십자인대 재건술에 있어서 이중다발과 재건술과 단일다발 재건술의 임상적 결과 및 방사선학적 결과에 대한 전향적 연구를 수행하고자 하였다. 대상 및 방법: 연구는 편측 무릎의 전방십자인대 손상이 있는 56명의 환자군(group T)을 모집하여 27명은 이중다발 재건술군으로 배정하였으며(group D), 29명은 단일다발 재건술군으로 배정하였다(group S). 두 비교군 간의 임상적인 수술 결과는 최소 2년간의 추적 관찰 기간 내 Lysholm knee score, Tegner activity score, Lachman & pivot shift test와 영상 검사(슬관절 전후방 부하 X선 촬영검사)를 통하여 비교 분석하였다. 결과: 술후 2년 추적 관찰에서의 Lysholm knee score, Tegner activity score 수치에서, 두 비교군 사이에 유의한 임상적 차이를 보이지 않았다(p>0.05). Lachman test, pivot shift test와 영상 검사 결과상에서도 두 비교군 사이에 유의한 차이점이 밝혀지지 않았다(p>0.05). 결론: 이중다발 전방십자인대 재건술은 최소 2년간의 추적 관찰에서, 단일다발 재건술에 비해 임상적 결과나, 수술 후 영상 검사 상에서의 우월함을 보이지 못하였다. 이는 전방십자인대 손상 환자들에서 전내측 다발 재건술만으로도 우수한 임상적 결과가 나올 수 있음을 시사한다.

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노인 구강건조증에 대한 음허 진단의 유용성 및 주관적 구강건조감의 영향요인 : 전향적 단면 조사 연구 (Availability of Diagnosis of Yin-deficiency in Elderly People with Xerostomia and Factors Influencing Subjective Oral Dryness: A Prospective Cross-sectional Study)

  • 김주연;김진성;박재우;류봉하
    • 대한한의학회지
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    • 제34권3호
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    • pp.13-24
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    • 2013
  • Objectives: The aims of this study were to investigate the availability of diagnosis of Yin-deficiency in the elderly with xerostomia and factors influencing subjective oral dryness. Methods: We surveyed 50 patients recruited by the clinical trial, 'Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized, Double-blind, Placebo-controlled, Two-center Trial'. The subjects were assessed on their subjective oral dryness using the Dry Mouth Symptom Questionnaire (DMSQ). Their salivary functions were measured by Unstimulated Salivary Flow Rate (USFR) measurements. In addition, the subjects were evaluated on their Qi-stagnation and Yin-deficiency conditions using the Qi-stagnation questionnaire and Yin-deficiency questionnaire. Results: There were statistically significant correlations between three variables (USFR, DMSQ score and Qi-stagnation score) and Yin-deficiency score. In the multiple regression analysis, the regression model was statistically significant (F = 10.273, p < .001). The factor most strongly influencing the subjective oral dryness was USFR (${\beta}$ = -0.386). Yin-deficiency had the next strongest impact on the subjective oral dryness (${\beta}$ = 0.371). Qi-stagnation affected the subjective oral dryness weakly (${\beta}$ = 0.075). In the simple regression analysis, Yin-deficiency had a statistically significant effect on each of six subscales of DMSQ (p < .01). Among the six subscales, DMSQ-1 ('Oral dryness at night or on awakening') was the most strongly influenced by Yin-deficiency. Conclusions: The results of this study show that the diagnosis of Yin-deficiency in the elderly with xerostomia was available and Yin-deficiency was an important factor influencing the subjective oral dryness. Therefore, the consideration of Yin-deficiency is significant for diagnosis and treatment in the elderly with xerostomia.