• 제목/요약/키워드: Prospective randomized trial

검색결과 155건 처리시간 0.036초

Post-operative analgesia of 2% lignocaine with or without magnesium sulfate for inferior alveolar nerve block in symptomatic mandibular molars - a randomized double blind controlled clinical trial

  • Chandrasekaran, Charanya;Vijay, Amirtharaj L;Sekar, Mahalaxmi;Mary, Nancy S
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권3호
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    • pp.147-154
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    • 2020
  • Background: Single inferior alveolar nerve block is ineffective in achieving adequate pulpal anesthesia in 30-80% of patients due to anatomical variations, local tissue pH, central sensitization, and several factors. Various supplementary techniques and combination of adjuvants with lignocaine are used to overcome these failures. Magnesium sulfate (MgSO4), one such adjuvant, acts at the N-methyl-D-aspartate glutamate receptor resulting in effective anesthesia. The aim of this prospective, randomized, double-blind, clinical controlled trial was to evaluate the onset, anesthetic efficacy, duration and post-operative analgesia of 2% lignocaine with and without the addition of MgSO4 in patients with symptomatic irreversible pulpitis and apical periodontitis. Methods: Fourty-two patients were randomly divided into three groups: 2% lignocaine (group 1) and 2% lignocaine with MgSO4 (75 mg) and (150 mg) in groups 2 and 3, respectively. Pre-operative vitals and Heft Parker-Visual Analogue Scale (HP-VAS) pain scores were recorded. The onset of anesthesia, anesthetic efficacy, and duration of anesthesia were evaluated post administration of the local anesthetic solution. The post-operative analgesia was examined at intervals of 2, 6, 12, 24, and 48 h. Results: Administration of 150 mg MgSO4 hastens the onset of anesthesia (1.29 min) and produces better anesthetic efficacy (3.29 HP-VAS) compared to group 2 (2.07 min and 9.14 HP-VAS) and group 1 (3.29 min and 35.79 HP-VAS), respectively. The duration of anesthesia was significantly higher in group 3 (247.07 min) compared to that of groups 2 and 1 (190 min and 110.21 min) with P < 0.05. Conclusion: Combining 75 mg or 150 mg of MgSO4 with lignocaine is more effective than 2% lignocaine and 75 mg of MgSO4 is adequate for endodontic procedures.

Efficacy of a Novel Annular Closure Device after Lumbar Discectomy in Korean Patients : A 24-Month Follow-Up of a Randomized Controlled Trial

  • Cho, Pyung Goo;Shin, Dong Ah;Park, Sang Hyuk;Ji, Gyu Yeul
    • Journal of Korean Neurosurgical Society
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    • 제62권6호
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    • pp.691-699
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    • 2019
  • Objective : Lumbar discectomy is an effective treatment for lumbar disc herniation (LDH); however, up to 2-18% of patients with LDH have experienced recurrent disc herniation. The purpose of this study was to evaluate the efficacy of a novel annular closure device (ACD) for preventing LDH recurrence and re-operation compared with that of conventional lumbar discectomy (CLD). Methods : In this prospective randomized controlled trial, we compared CLD with discectomy utilizing the $Barricaid^{(R)}$ (Intrinsic Therapeutics, Inc., Woburn, MA, USA) ACD. Primary radiologic outcomes included disc height, percentage of preoperative disc height maintained, and re-herniation rates. Additional clinical outcomes included visual analog scale (VAS) scores for back and leg pain, Oswestry Disability Index (ODI) scores, and 12-item short-form health survey (SF-12) quality of life scores. Outcomes were measured at preoperation and at 1 week, 1, 3, 6, 12, and 24 months postoperation. Results : Sixty patients (30 CLD, 30 ACD) were enrolled in this study. At 24-month follow-up, the disc height in the ACD group was significantly greater than that in the CLD group ($11.4{\pm}1.5$ vs. $10.2{\pm}1.2mm$, p=0.006). Re-herniation occurred in one patient in the ACD group versus six patients in the CLD group (${\chi}^2=4.04$, p=0.044). Back and leg VAS scores, ODI scores, and SF-12 scores improved significantly in both groups compared with preoperative scores in the first 7 days following surgery and remained at significantly improved levels at a 24-month follow-up. However, no statistical difference was found between the two groups. Conclusion : Lumbar discectomy with the $Barricaid^{(R)}$ (Intrinsic Therapeutics, Inc.) ACD is more effective at maintaining disc height and preventing re-herniation compared with conventional discectomy. Our results suggest that adoption of ACD in lumbar discectomy can help improve the treatment outcome.

Efficacy of buccal piroxicam infiltration and inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial

  • Saurav Paul;Sridevi Nandamuri;Aakrati Raina;Mukta Bansal
    • Restorative Dentistry and Endodontics
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    • 제46권1호
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    • pp.9.1-9.9
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    • 2021
  • Objectives: This randomized clinical trial aimed to assess the effectiveness of buccal infiltration with piroxicam on the anesthetic efficacy of inferior alveolar nerve block (IANB) with buccal infiltration in irreversible pulpitis, with pain assessed using the Heft-Parker visual analogue scale (HP-VAS). Materials and Methods: This study included 56 patients with irreversible pulpitis in mandibular molars, randomly distributed between 2 groups (n = 28). After evaluating the initial pain score with the HP-VAS, each patient received IANB followed by buccal infiltration of 2% lignocaine with adrenaline (1:80,000). Five minutes later, the patients in groups 1 and 2 were given buccal infiltration with 40 mg/2 mL of piroxicam or normal saline, respectively. An access opening procedure (AOP) was performed 15 minutes post-IANB once the individual showed signs of lip numbness as well as 2 negative responses to electric pulp testing. The HP-VAS was used to grade the patient's pain during caries removal (CR), AOP, and working length measurement (WLM). Successful anesthesia was identified either by the absence of pain or slight pain through CR, AOP, and WLM, with no requirement of a further anesthetic dose. A statistical analysis was done using the Shapiro-Wilk and Mann-Whitney U tests. Results: The piroxicam group presented a significantly lower (p < 0.05) mean pain score than the saline group during AOP. Conclusions: Buccal infiltration with piroxicam enhanced the efficacy of anesthesia with IANB and buccal infiltration with lignocaine in patients with irreversible pulpitis.

Porcine-derived soft block bone substitutes for the treatment of severe class II furcation-involved mandibular molars: a prospective controlled follow-up study

  • Jae-Hong Lee;Ji-Hoo Han;Seong-Nyum Jeong
    • Journal of Periodontal and Implant Science
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    • 제53권6호
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    • pp.406-416
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    • 2023
  • Purpose: No evidence exists regarding the advantages of periodontal regeneration treatment for furcation defects using soft block bone substitutes. Therefore, this randomized controlled trial aimed to assess the clinical and radiographic outcomes of regenerative therapy using porcine-derived soft block bone substitutes (DPBM-C, test group) compared with porcine-derived particulate bone substitutes (DPBM, control group) for the treatment of severe class II furcation defects in the mandibular molar regions. Methods: Thirty-five enrolled patients (test group, n=17; control group, n=18) were available for a 12-month follow-up assessment. Clinical (probing pocket depth [PPD] and clinical attachment level [CAL]) and radiographic (vertical furcation defect; VFD) parameters were evaluated at baseline and 6 and 12 months after regenerative treatment. Early postoperative discomfort (severity and duration of pain and swelling) and wound healing outcomes (dehiscence, suppuration, abscess formation, and swelling) were also assessed 2 weeks after surgery. Results: For both treatment modalities, significant improvements in PPD, CAL, and VFD were found in the test group (PPD reduction of 4.1±3.0 mm, CAL gain of 4.4±2.9 mm, and VFD reduction of 4.1±2.5 mm) and control group (PPD reduction of 2.7±2.0 mm, CAL gain of 2.0±2.8 mm, and VFD reduction of 2.4±2.5 mm) 12 months after the regenerative treatment of furcation defects (P<0.05). However, no statistically significant differences were found in any of the measured clinical and radiographic parameters, and no significant differences were observed in any early postoperative discomfort and wound healing outcomes between the 2 groups. Conclusions: Similar to DPBM, DPBM-C showed favorable clinical and radiographic outcomes for periodontal regeneration of severe class II furcation defects in a 12-month follow-up period.

Efficacy of Commiphora myrrha and Honey in Primary Dysmenorrhea: A Randomized Controlled Study

  • Aneesa K, Haleema;Roqaiya, Mariyam;Quadri, Mohd Aqil
    • 셀메드
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    • 제11권4호
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    • pp.19.1-19.8
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    • 2021
  • Background: Dysmenorrhea is the most common menstrual complaint in young women with a prevalence as high as 90% and is responsible for substantial repeated short-term absenteeism from school and work in young women. The objective of this study was to compare the efficacy of Commiphora myrrha and honey with mefenamic acid in primary dysmenorrhea. Materials and Methods: This prospective standard controlled trial was conducted at Luqman Unani Medical College Hospital and Research Center Vijayapura, India where 40 diagnosed patients of primary dysmenorrhea were randomly assigned to receive test drug (powdered Commiphora myrrha gum resin10g with 30g honey in two divided doses) or active control drug (mefenamic acid 250mg TID) for first 3days of menstruationfor two consecutive cycles. The primary outcome measure was reduction in severity of pain assessed by numerical pain rating scale (NPRS), and secondary outcome measures were improvement in quality of life (QOL) assessed by SF-36 and reduction in perceived stress score (PSS). Results: During first cycle treatment no significant difference was found in NPRS score (p=0.085) between the groups however significant difference in NPRS score (p<0.001) was seen during 2nd treatment cycle. Significant reduction (p=0.022) in the perceived stress score was noted and overall quality of life was markedly improved after treatment in both the groups. Conclusion: These data suggest that Commiphora myrrha gum resin with honey is an effective herb in reducing symptoms of primary dysmenorrhea. These results need to be confirmed by a properly designed trial with a larger sample size. Trial registration: Clinical Trial Registry India CTRI/2017/09/009596.

암성통증에 대한 SBVP 효과 - 무작위대조시험, 이중맹검 (The Effect of Sweet Bee Venom Pharmacopuncture(SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study)

  • 유화승;김정선
    • 대한약침학회지
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    • 제11권1호
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    • pp.21-29
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    • 2008
  • Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

Comparison of sandblasted and acid-etched surface implants and new hydrophilic surface implants in the posterior maxilla using a 3-month early-loading protocol: a randomized controlled trial

  • Kim, Hyeong Gi;Yun, Pil-Young;Kim, Young-Kyun;Kim, Il-hyung
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제47권3호
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    • pp.175-182
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    • 2021
  • Objectives: In this prospective randomized controlled trial, we measured the primary and secondary stability of two surface-treated implants placed in the posterior maxilla, applied 3-month loading protocols, and compared and analyzed the short-term outcomes of the implants. Patients and Methods: From June 2018 to June 2019, patients with a residual bone height of 4 mm in the posterior maxilla were enrolled and randomly divided into two groups to place SA implants (Osstem Implants, Korea) in Group A and NH implants (Hiossen, USA) in Group B. Finally, 14 implants placed in 13 patients in Group A and 17 implants placed in 14 patients in Group B were analyzed. The measured primary and secondary stability of each implant was represented by implant stability quotient (ISQ), and treatment outcomes were evaluated. Results: Group A consisted of patients with an average age of 62.2 years (range, 48-80 years), and Group B consisted of patients with an average age of 58.1 years (range, 35-82 years). Primary stability was 73.86±6.40 and 71.24±5.32 in Groups A and B, respectively (P=0.222). Secondary stability was 79.07±5.21 in Group A and 78.29±4.74 in Group B (P=0.667). A steep increase in ISQ during the healing period was observed in Group B, though it was not significant (P=0.265). The mean follow-up period was 378.5±164.6 days in Group A and 385.3±167.9 days in Group B. All implants in each group met the success criteria, and the success rate was 100%. Conclusion: Two surface-treated implants placed in the posterior maxilla with greater than 4 mm alveolar bone height exhibited successful one-year treatment outcomes if a primary stability of 65 or higher ISQ was obtained and a 3-month early loading protocol was applied.

위암의 선행화학 요법 (Preoperative Chemotherapy in Gastric Cancer)

  • 홍영선;박조현
    • Journal of Gastric Cancer
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    • 제5권3호
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    • pp.139-145
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    • 2005
  • 위암은 한국에서 가장 발생빈도가 높은 암이며 암 사망원인의 2위를 차지하고 있다. 치료법 중에서 수술이 유일하게 완치의 기회를 제공하나, 진행 암에서는 근치적 절제(R0 resection, R0 절제)수술 후에도 약 50%의 환자에서 재발을 보여, 보다 효과적인 치료법의 개발이 필요하다. 선행화학요법은 병소가 급격하게 성장, 팽창하는 것을 막고 내성을 지닌 세포의 출현을 예방하며 그렇게 함으로써 완치의 기회를 늘리고, 암의 국소 조절을 더 잘 함으로서 수술의 범위를 줄여 수술로 인한 부담을 줄이며, 절제 불가능한 암을 절제 가능한 암으로 만드는 것이 목표이다. 따라서 치유절제가 불가능할 것으로 판단되었던 위암의 병기를 낮추어 R0 절제 후 완치율을 높일 것으로 기대되고 있으며 계속되는 연구에서 수술로 인한 이환율과 사망률을 높이지 않는 것으로 나타나고 있다. 선행 화학요법에 사용할 수 있는 항암제는 여러 가지이나 가장 높은 효과를 보이는 항암제가 결정되지 않았고 또 항암제를 투여하는 시기, 선행 화학요법 후에 재발을 방지하기 위한 항암제의 복강 내 투여나 방사선 치료의 병용 등이 복막 전이와 국소재발을 줄이는 데 도움이 되는지 등이 향후 시행될 연구에서 규명되어야 하겠고, 또 적절한 수술방법에 관하여도 합의가 이루어져야 하겠다. 선행 화학요법과 관련된 여러 가지 의문들을 해결하기 위한 노력은 다기관이 참여하는 전향적 무작위 3상 임상연구를 통하여 이루어져야 할 것으로 생각된다.

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Effectiveness of virtual reality immersion on procedure-related pain and anxiety in outpatient pain clinic: an exploratory randomized controlled trial

  • Joo, Young;Kim, Eun-Kyung;Song, Hyun-Gul;Jung, Haesun;Park, Hanssl;Moon, Jee Youn
    • The Korean Journal of Pain
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    • 제34권3호
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    • pp.304-314
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    • 2021
  • Background: The study investigated virtual reality (VR) immersion in alleviating procedure-related pain in patients with chronic pain undergoing fluoroscopy-guided minimally-invasive intervention in a prone position at an outpatient clinic. Methods: In this prospective randomized controlled study, 38 patients undergoing lumbar sympathetic ganglion block were randomized into either the VR or the control group. In the VR group, procedure-related pain was controlled via infiltration of local anesthetics while watching a 30-minute VR hypnotic program. In the control group, the skin infiltration alone was used, with the VR device switched off. The primary endpoint was an 11-point score on the numerical rating scale, indicating procedure-related pain. Patients' satisfaction with pain control, anxiety levels, the need for additional local anesthetics during the procedure, hemodynamic stability, and any adverse events were assessed. Results: Procedure-related pain was significantly lower in the VR group (3.7 ± 1.4) than in the control group (5.5 ± 1.7; P = 0.002). Post-procedural anxiety was lower in the VR group than in the control group (P = 0.025), with a significant reduction from pre-procedural anxiety (P < 0.001). Although patients' satisfaction did not differ significantly (P = 0.158) between the groups, a higher number of patients required additional local anesthetics in the control group (n = 13) than in the VR group (n = 4; P = 0.001). No severe adverse events occurred in either group during the study. Conclusions: VR immersion can be safely used as a novel adjunct to reduce procedural pain and anxiety during fluoroscopic pain intervention.

Efficacy of extracorporeal shock wave therapy for pillar pain after open carpal tunnel release: a double-blind, randomized, sham-controlled study

  • Turgut, Mehmet Cenk;Saglam, Gonca;Toy, Serdar
    • The Korean Journal of Pain
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    • 제34권3호
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    • pp.315-321
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    • 2021
  • Background: Pillar pain may develop after carpal tunnel release surgery (CTRS). This prospective double-blinded randomized trial investigated the effectiveness of extracorporeal shock wave therapy (ESWT) in pillar pain relief and hand function improvement. Methods: The sample consisted of 60 patients with post-CTRS pillar pain, randomized into two groups. The ESWT group (experimental) received three sessions of ESWT, while the control group received three sessions of sham ESWT, one session per week. Participants were evaluated before treatment, and three weeks, three months, and six months after treatment. The pain was assessed using the visual analogue scale (VAS). Hand functions were assessed using the Michigan hand outcomes questionnaire (MHQ). Results: The ESWT group showed significant improvement in VAS and MHQ scores after treatment at all time points compared to the control group (P < 0.001). Before treatment, the ESWT and control groups had a VAS score of 6.8 ± 1.3 and 6.7 ± 1.0, respectively. Three weeks after treatment, they had a VAS score of 2.8 ± 1.1 and 6.1 ± 1.0, respectively. Six months after treatment, the VAS score was reduced to 1.9 ± 0.9 and 5.1 ± 1.0, respectively. The ESWT group had a MHQ score of 54.4 ± 7.7 before treatment and 73.3 ± 6.8 six months after. The control group had a MHQ score of 54.2 ± 7.1 before treatment and 57.8 ± 4.4 six months after. Conclusions: ESWT is an effective and a safe non-invasive treatment option for pain management and hand functionality in pillar pain.