• Title/Summary/Keyword: Prospective Effects

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A Prospective, Multi-Center, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used during the TLIF Procedure in Patients with Lumbar Disc Disease

  • Hyun, Seung-Jae;Yoon, Seung Hwan;Kim, Joo Han;Oh, Jae Keun;Lee, Chang-Hyun;Shin, Jun Jae;Kang, Jiin;Ha, Yoon
    • Journal of Korean Neurosurgical Society
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    • v.64 no.4
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    • pp.562-574
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    • 2021
  • Objective : This study is to evaluate the efficacy and safety of demineralized bone matrix (DBM) gel versus DBM gel with recombinant human bone morphogenetic protein-2 (rhBMP-2) used in transforaminal lumbar interbody fusion (TLIF). Methods : This study was designed as a prospective, multi-center, double-blind method, randomized study. All randomized subjects underwent TLIF with DBM gel with rhBMP-2 group (40 patients) as an experimental group or DBM gel group (36 patients) as a control group. Post-operative observations were performed at 12, 24, and 48 weeks. The spinal fusion rate on computed tomography scans and X-rays films, Visual analog scale pain scores, Oswestry disability index and SF-36 quality of life (QOL) scores were used for the efficacy evaluation. The incidence rate of adverse device effects (ADEs) and serious adverse device effects (SADEs) were used for safety evaluation. Results : The spinal fusion rate at 12 weeks for the DBM gel with rhBMP-2 group was higher with 73.68% compared to 58.82% for the DBM gel group. The 24 and 48 weeks were 72.22% and 82.86% for the DBM gel with rhBMP-2 group and 78.79% and 78.13%, respectively, for the DBM gel group. However, there were no significant differences between two groups in the spinal fusion rate at 12, 24, and 48 weeks post-treatment (p=0.1817, p=0.5272, p=0.6247). There was no significant difference between the two groups in the incidence rate of ADEs (p=0.3836). For ADEs in the experimental group, 'Pyrexia' (5.00%) was the most common ADE, followed by 'Hypesthesia', 'Paresthesia', 'Transient peripheral paralysis', 'Spondylitis' and 'Insomnia' (2.50%, respectively). ADEs reported in control group included 'Pyrexia', 'Chest discomfort', 'Pain', 'Osteoarthritis', 'Nephropathy toxic', 'Neurogenic bladder', 'Liver function analyses' and 'Urticaria' (2.86%, respectively). There was no significant difference between the two groups in the incidence rate of SADEs (p=0.6594). For SADE in the experimental group, ''Pyrexia' and 'Spondylitis' were 2.50%. SADE reported in the control group included 'Chest discomfort', 'Osteoarthritis' and 'Neurogenic bladder'. All SADEs described above were resolved after medical treatment. Conclusion : This study demonstrated that the spinal fusion rates of DBM gel group and DBM gel with rhBMP-2 group were not significantly different. But, this study provides knowledge regarding the earlier postoperative effect of rhBMP-2 containing DBM gel and also supports the idea that the longer term follow-up results are essential to confirm the safety and effectiveness.

Effects of Sequential Application of Superficial Cold and Heat on Pain, Patient Satisfaction with Pain Control, Comfort Level and Subjective Response after Spine Surgery (순차적 냉·온 요법이 척추 수술 후 통증과 통증 조절 만족도, 안위, 주관적 반응에 미치는 효과)

  • Kim, Jeoung Hee;Lhim, Seung Chul;Roh, Sung Woo;Lee, Sun Jin;Ko, Young Mi;Kim, Yeo Ok;Shin, Yong Soon
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.23 no.2
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    • pp.184-193
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    • 2016
  • Purpose: The aims of the current study were to evaluate the effects of superficial cold and heat after spine surgery on pain, satisfaction with pain control and comfort level, and to identify subjective responses and adverse effects. Methods: A prospective, single-blind, randomized controlled trial was utilized. The intervention group (n=36) received superficial cooling until the wound drain was removed and thereafter followed by superficial heating until discharge, while the control group (n=34) received only superficial cooling until wound drain was removed. Data were collected from August 4 to November 11 2014. Results: There was significant difference in pain according to time within groups (F=71.87, p<.001). However, we found no difference in pain between groups. The intervention group reported higher patient satisfaction with pain control (4 vs 3, z=-2.83, p=.005) and higher comfort level (5 vs 4, z=-4.12, p<.001) than the control group. Conclusion: Results indicate that sequential application of superficial cold and heat is a useful method in clinical practice for management of pain after spine surgery.

The Comparison between Acupotomy Therapy and Epidural Neuroplasty(Lumbar Vertebra) (침도(도침)침술과 경막외 신경성형술의 비교 연구)

  • Song, In;Hong, Kwon-Eui
    • Journal of Acupuncture Research
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    • v.27 no.4
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    • pp.9-18
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    • 2010
  • Objectives : This study will broaden understanding of acupotomy therapy through comparison of side effects and complication which can be caused by the mechanism of treatment, surgical methods, and procedure by acupotomy therapy and epidural neuroplasty. Moreover, through an in-depth analysis of headache affected by two procedures, this research is supposed to find prospective cures for headache after acupotomy therapy. Methods : To compare acupotomy therapy with epidural neuroplasty this research was done using a comparative analysis eight theses about acupotomy therapy since 1995, as well as eleven theses about epidural neuroplasty since 2000. Other theses and data were used as references in the process of comparative analysis. Results : Acupotomy therapy and epidural neuroplasty, new treatments of damaged discs in the spine and stenosis made in 1990s, have the mechanism of treatment in common in that adhesion, a node or scar caused by the soft tissue damage is removed by putting catheter or acupuncture into the lesions. Epidural neuroplasty has additional injection into the lesions, which is different from acupotomy therapy in the process of surgical procedure. There are various reports of positive effects about curative effect in these two treatments. The two procedures may cause various complications. Headache may be a complication after surgery. The headache after acupotomy therapy is characterized as being an ache in the body, which is similar to that of post-dural puncture headache in the outbreaks and symptom. Headache after percutaneous epidural neuroplasty appears in general, which is similar to a headache as a result of the increased pressure of the brain spinal cord regardless of posture. Conclusions : Although they are alike in the mechanism of treatment, surgical methods and side effects, and complication after they are carried out as a result of analyzing theses related to acupotomy therapy and percutaneous epidural neuroplasty, there is a difference in aspects and mechanism of headaches experienced after the procedure.

The effect of atropine in preventing catheter-related pain and discomfort in patients undergoing transurethral resection due to bladder tumor; prospective randomized, controlled study

  • Sahiner, Yeliz;Yagan, Ozgur;Ekici, Arzu Akdagli;Ekici, Musa;Demir, Emre
    • The Korean Journal of Pain
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    • v.33 no.2
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    • pp.176-182
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    • 2020
  • Background: Catheter-related bladder discomfort (CRBD) has been observed in many patients undergoing a urethral catheterization. CRBD may be so severe that the patients require additional analgesics. Muscarinic receptors are involved in the mechanism of CRBD. The aim of this study is to determine the effects of the antimuscarinic properties of atropine, which is frequently used in current practice on CRBD, by comparing it with sugammadex which has no antimuscarinic effects. Methods: Sixty patients selected for transurethral resection due to bladder tumors were randomized into 2 groups: an atropine group and a sugammadex group, with no antimuscarinic effect. The patients were given rocuronium (0.6 mg/kg) as a neuromuscular-blocker. In addition to the frequency and severity of CRBD postoperatively at 0, 1, 6, 12, and 24 hours, postoperative numeric rating scale (NRS) scores, and postoperative nausea and vomiting were examined. Results: The incidence of CRBD was significantly lower in the atropine group in all postoperative measurements. The score was found to be significantly lower in the atropine group when NRS measurements were performed at all time periods (P < 0.01). There was no difference between the groups in terms of nausea and vomiting (P > 0.05). Conclusions: Atropine is a cheap, easy-to-access, safe-to-use drug for reducing CRBD symptoms, without any observed adverse effects. Since it not only reduces CRBD symptoms but also has a positive effect on postoperative pain, it can be used safely to increase patient comfort in patients receiving general anesthesia and a urinary catheter.

The pilot study for the effects of Doin-Angyo program in reducing stress among high school students in Gyeongsangbukdo, Korea (경상북도 일부 고교생을 대상으로 한 도인안교의 스트레스 저하 효과에 대한 파일럿 연구)

  • Park, Hye Jung;Lee, Sangjae;Lim, Byungmook
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.2
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    • pp.59-67
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    • 2014
  • Objective : This study was to examine the effects of Doin-Angyo program, evidenced by East Asian Medicine literatures, on stress among smoking adolescents. Method : This study was a prospective community trial using a one-group, pretest-posttest design. As an intervention, Doin-Angyo program was implemented for 10 minutes per session, 3 days a week, for 6 weeks to smoking students who attend a Girl's high school. Psychological stress was measured by self-report questionnaire and physiological stress was measured by salivary cortisol. The final sample for the questionnaire included 18 participants. In addition, pre- and post-salivary cortisol levels of 24 adolescents participating in the last session were compared in order to identify the acute effects of Doin-Angyo program in reducing stress. Results : There were no significant differences in overall stress-test results from the comparisons before and after the intervention. However, we found a significant going-down of the stress level(p = .032) in the question, "About School-work" among six sub-category questions. From the salivary cortisol tests in the last session, we found, in comparison with the standard salivary cortisol density level, $0.3{\mu}g/dL$, the density level tended to go down(p = .062) when higher than the standard, and it went up(p = .001) when lower than the standard, after 10 minute session. Conclusion : The results of this pilot study supported the partial effect of Doin-Angyo program in reducing the stress levels. The study protocol and results can be used to elaborate the community trials design aiming to prove the effect of Korean Medicine based health promotion modalities.

Effects of coagulation factor concentrate prophylaxis in moderate and severe hemophilia A patients at a single hemophilia center in Korea

  • Moon, Byung Suk;Choi, Jun Seok;You, Chur Woo
    • Clinical and Experimental Pediatrics
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    • v.56 no.7
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    • pp.291-297
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    • 2013
  • Purpose: The aim of this study was to investigate prophylactic treatment effects in Korean patients with severe hemophilia A. Methods: A prospective study of 32 severe hemophilia A patients was conducted with the approval of the Institutional Review Board at the Eulji University Hospital. Two patients received primary prophylaxis; whereas, the other 30 patients were divided into 2 groups-secondary prophylaxis (n=15) and on-demand (n=15)-on the basis of their consent for secondary prophylaxis. A 20-25 IU/kg dose of factor VIII concentrate was administered to the primary and secondary prophylaxis group patients every 3 days for 1 year. The prophylactic effect was evaluated by observing changes in the Pettersson scores, annual number of total and joint bleeds, and factor VIII consumption for 1 year. Results: No moderate or severe bleeding was observed, and the Pettersson scores remained unchanged during the prophylaxis period in the patients who received primary prophylactic treatment. After the treatment was changed from on-demand to secondary prophylaxis, the annual number of total and joint bleeds in the secondary prophylaxis group decreased by $64.4%{\pm}13.0%$ and $70.0%{\pm}15.2%$, respectively. The average increase in Pettersson scores within 1 year was $0.5{\pm}0.8$ and $1.3{\pm}1.1$ in the secondary prophylaxis and on-demand groups, respectively. Prophylactic effects were also observed in patients >17 years who had nearly the same initial Pettersson scores. Conclusion: Intermediate-dose prophylactic treatment may delay hemarthropathy progression and prevent its occurrence in Korean severe hemophilia A patients.

Effects of feminine cleanser Inclear on sperm motility: A prospective study

  • Park, Dong-Wook;An, Jin Hee;Han, Sang Chul;Lee, Jongwon;Lee, Hyo Serk;Seo, Ju Tae
    • Clinical and Experimental Reproductive Medicine
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    • v.41 no.4
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    • pp.165-167
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    • 2014
  • Objective: The objective of this study is to estimate the effects of Inclear, a feminine cleanser, on sperm motility. Methods: Semen samples were obtained from infertile male patients. Following liquefaction, the raw semen samples were diluted with Ham's F-10 nutrient mixture medium containing 0.4% human serum albumin solution at a ratio of 1:3. The semen samples were subsequently centrifuged to separate the seminal plasma from the serum. The supernatant was discarded, and the pellet was resuspended. The sample was again centrifuged to remove cell debris, and the supernatant was removed. The final pellet was gently loosened by resuspension and incubated in medium alone as a control, and in a 10% solution of the medium plus Inclear. A sampling time of 30 minutes was selected on the basis of sperm transport studies. Sperm motility was evaluated with computer-assisted sperm analysis. Results: A total of 20 samples were analyzed. The mean age of patients was $34.40{\pm}2.96years$. There was no difference in sperm concentration and motility in the two samples at 0 minute and 30 minutes of incubation. In both semen samples, the sperm concentration and motility decreased after an incubation period of 30 minutes. However, there was no statistical difference between the samples. Sperm concentration and motility were not significantly different between the control and Inclear samples after 0 minute and 30 minutes of incubation. Conclusion: Inclear has no negative effects on sperm motility. This product can be recommended to pregnancy planners for vaginal hygiene and as a vaginal lubricant.

Comparison on the Efficacy of Quetiapine Versus Haloperidol in the Treatment of Delirium : Prospective, Randomized Trial (섬망 환자에서 Quetiapine과 Haloperidol의 치료 효과 비교 : 전향적, 무작위 연구)

  • Lee, Yu-Jin;Jung, Han-Yong;Lee, Soyoung Irene;Kim, Shin Gyeom;Park, Joon Ho
    • Korean Journal of Biological Psychiatry
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    • v.16 no.1
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    • pp.15-24
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    • 2009
  • Objectives : The purpose of this study is to examine the efficacy and side effects of quetiapine and haloperidol for the treatment of symptoms of delirium. Methods : One hundred and seven patients with delirium were recruited and randomly assigned to receive a flexible-dose regimen of quetiapine or haloperidol over 7days and seventy-seven patients completed the study(quetiapine group N=40, haloperidol group N=37). The severity of delirium was assessed by using Memorial Delirium Assessment Scale(MDAS) scores, the psychiatric and behavioral symptoms were assessed by Neurobehavioral Rating Scale(NRS) scores, and the cognitive status was measured by Mini-mental state examination Korean version(MMSE-K) scores. The side effects were measured by Drug Induced Extrapyramidal Symptoms Scale(DIEPSS) scores. Results : MDAS scores significantly improved in both treatment groups. NRS scores also significantly improved in both treatment group, but the group-by-time effect approached significance, likely caused by the greater decrease in scores of the quetiapine group. MMSE-K scores significantly improved only in the quetiapine group. Side effects associated with treatment were not significant in either treatment groups. Conclusion : This study suggests that quetiapine is as efficacious as haloperidol in the treatment of delirium. In particular, quetiapine seems to improve psychiatric and behavioral problems of delirium and was more effective than haloperidol in cognitive improvement.

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Effects of Passive Music Listening on Psychological Well-Being and Depression in Undergraduate Nursing Students (수동적 음악청취가 간호대학생의 심리적 안녕감과 우울에 미치는 효과)

  • Yoo, Moon-Sook;Park, Jee-Won;Song, Mi-Sook;You, Mi-Ae;Park, Hyung-Ran
    • Journal of Korean Public Health Nursing
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    • v.27 no.3
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    • pp.490-499
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    • 2013
  • Purposes: This study was conducted in order to investigate the effects of passive music listening on psychological well-being and depression in 134 nursing students enrolled in two colleges of nursing in Kyeonggi-do, Korea. Methods: A prospective, pretest and posttest, controlled, quasi-experimental design was used. An intervention group (n= 74) participated in a 14-week passive music listening program before and after each lecture while those who were assigned as a control group (n=60) were given a series of traditional lectures. Analysis of data was performed using chi-square test, independent t-test, and Mann-Whitney U test, using SPSS 19.0. Results: Although no significant difference was observed in psychological well-being (t=0.34, p=.738), depression (z=-3.19, p=.001) showed a significant difference in the experimental group compared to the control group. Conclusions: This study provided evidence of the beneficial impact of passive music listening for nursing students with depression. Conduct of further studies will be needed in order to verify the effects on psychological well-being.

Articaine (4%) with epinephrine (1:100,000 or 1:200,000) in inferior alveolar nerve block: Effects on the vital signs and onset, and duration of anesthesia

  • Lasemi, Esshagh;Sezavar, Mehdi;Habibi, Leyla;Hemmat, Seyfollah;Sarkarat, Farzin;Nematollahi, Zahra
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.15 no.4
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    • pp.201-205
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    • 2015
  • Background: This prospective, randomized, double-blind, clinical study was conducted to compare the effects of 4% articaine with 1:100,000 epinephrine (A100) and 4% articaine with 1:200,000 epinephrine (A200) on the vital signs and onset and duration of anesthesia in an inferior alveolar nerve block (IANB). Methods: In the first appointment, an IANB was performed by injecting A100 or A200 in 1 side of the mouth (right or left) randomly in patients referred for extraction of both their first mandibular molars. In the second appointment, the protocol was repeated and the other anesthetic solution was injected in the side that had not received the block in the previous session. Systolic and diastolic blood pressures (SBP and DBP) and pulse rate were measured during and 5 min after the injection. The onset and duration of anesthesia were also evaluated. Data were analyzed using t-test and Mann-Whitney U-test, and p-value was set at 0.05. Results: SBP and pulse rate changes were slightly more with A100; however, DBP changes were more with A200, although the differences were not significant (P > 0.05). There were no statistically significant differences in the parameters evaluated in this study. The onset and duration of anesthesia, and the changes in SBP, DBP, and pulse rate during and 5 min after the injection were the same in both the groups. Conclusions: For an IANB, A200 and A100 were equally efficient and successful in producing the block. Epinephrine concentration did not influence the effects of 4% articaine.