• Journal of Korean Neurosurgical Society
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• 제39권1호
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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.

• 동의생리병리학회지
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• 제22권1호
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• pp.234-245
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• 2008

Yeonkyopaedok-san(YPS) extract is widely used to treat the common cold. The purpose of this study was to evaluate the efficacy of YPS on the common cold. Two hundred Patients with common colds of recent onset were randomized to the double blind, placebo-controlled study. They received 800 mg YPS extract or placebo in capsules, orally dissolved 3 times a day for 7 days. The total symptom score was assessed by the physician, using a 5-point scale on start and finish. Resolution of cold symptoms based on subjective daily symptoms. Total symptom score was significantly decreased in YPS groups in comparison to that in placebo group (p=0.027). Headache (p=0.012), loss of appetite (p=0.037), eyeball discomfort (p=0.002) were more affected. Time to resolution of cold symptoms did not show significant effect (p=0.592). Adverse effects were less in the YPS group than placebo group (2% vs 3%). In this community-based, randomized controlled trial, YPS were effective in treating cold symptoms in college students.

• 대한한의학회지
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• 제27권4호
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• pp.225-232
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• 2006

Objective : To test the hypotheses that individualized traditional Korean acupuncture improves pain and disability in patients with osteoarthritis of the knee and that benefits remain after stopping treatment more so than is the case for standardized minimal acupuncture. Design : Randomized single blind controlled trial with two intervention arms (individualized traditional Korean acupuncture, standardized minimal acupuncture) of six weeks' duration and three months follow-up. Setting : Acupuncture interventions were applied by two training doctors in the Department of Acupuncture and Moxibustion in a 1000-bed hospital. Assessment of the result was performed in a university-based laboratory. Participants : 50 patients with symptoms of knee osteoarthritis as diagnosed by an orthopedist. Intervention : Individualized traditional Korean acupuncture or standardized minimal acupuncture for six weeks. Main outcome measures: Primary outcome measure was pain as measured by the visual analogue scale. Secondary measures of pain and disability included the Western Ontario and McMaster Universities (WOMAC) index, Short Form-36 (SF-36), Lequesne Functional Index (LFI) score and Korean version of Health Assessment Questionnaire (KHAQ). Discussion : This paper presents detail on the rationale, design, methods and operational aspects of the trial.

• The Korean Journal of Pain
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• 제31권1호
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• pp.27-38
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• 2018

Background: Related to escalating health care costs and the questionable effectiveness of multiple interventions including lumbar facet joint interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine influencing coverage decisions. Methods: Cost utility of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain was performed utilizing data from a randomized, double-blind, controlled trial with a 2-year follow-up, with direct payment data from 2016. Based on the data from surgical interventions, utilizing the lowest proportion of direct procedural costs of 60%, total cost utility per quality adjusted life year (QALY) was determined by multiplying the derived direct cost at 1.67. Results: Patients in this trial on average received $5.6{\pm}2.6$ procedures over a period of 2 years, with average relief over a period of 2 years of $82.8{\pm}29.6$ weeks with $19{\pm}18.77$ weeks of improvement per procedure. Procedural cost for one-year improvement in quality of life showed USD $2,654.08. Estimated total costs, including indirect costs and drugs with multiplication of direct costs at 1.67, showed a cost of USD $4,432 per QALY. Conclusions: The analysis of therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain shows clinical effectiveness and cost utility at USD $2,654.08 for the direct costs of the procedures, and USD $4,432 for the estimated overall cost per one year of QALY, in chronic persistent low back pain non-responsive to conservative management.

• The Journal of Advanced Prosthodontics
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• 제11권3호
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• pp.147-154
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• 2019

PURPOSE. This study aimed to evaluate the effect of two different implant-abutment connection structures with identical implant design on peri-implant bone level. MATERIALS AND METHODS. This clinical study was a patient-blind randomized controlled trial following the CONSORT 2010 checklists. This trial was conducted in 24 patients recruited between March 2013 and July 2015. Implants with internal friction connection were compared to those with external hex connection. One implant for each patient was installed, replacing the second molar. Implant-supported crowns were delivered at four months after implant insertion. Standardized periapical radiographs were taken at prosthesis delivery (baseline), and one year after delivery. On the radiographs, distance from implant shoulder to first bone-to-implant contact (DIB) and peri-implant area were measured, which were the primary and secondary outcome, respectively. RESULTS. Eleven external and eleven internal implants were analyzed. Mean changes of DIB from baseline to 1-year postloading were 0.59 (0.95) mm for the external and 0.01 (0.68) mm for the internal connection. Although no significant differences were found between the two groups, medium effect size was found in DIB between the connections (Cohen's d = 0.67). CONCLUSION. Considering the effect size in DIB, this study suggested the possibility of the internal friction connection structure for more effective preservation of marginal bone.

• The Korean Journal of Pain
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• 제34권3호
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• pp.346-368
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• 2021

Background: Recalcitrant disc herniation may result in chronic lumbar radiculopathy or sciatica. Fluoroscopically directed epidural injections and other conservative modalities may provide inadequate improvement in some patients. In these cases, percutaneous neurolysis with targeted delivery of medications is often the next step in pain management. Methods: An evidence-based system of methodologic assessment, namely, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used. Multiple databases were searched from 1966 to January 2021. Principles of the best evidence synthesis were incorporated into qualitative evidence synthesis. The primary outcome measure was the proportion of patients with significant pain relief and functional improvement (≥ 50%). Duration of relief was categorized as short-term (< 6 months) and long-term (≥ 6 months). Results: This assessment identified one high-quality randomized controlled trial (RCT) and 5 moderate-quality non-randomized studies with an application of percutaneous neurolysis in disc herniation. Overall, the results were positive, with level II evidence. Conclusions: Based on the present systematic review, with one RCT and 5 non-randomized studies, the evidence level is II for percutaneous neurolysis in managing lumbar disc herniation.

• 재활치료과학
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• 제9권2호
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• pp.27-38
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• 2020

서론 : 본 연구는 무작위 대조군 실험(Randomized control trial: 이하 RCT) 연구에서 치료의향분석(Intention-to-treat analysis)의 올바른 활용에 대해서 고찰하고자 한다. 본론 : 치료의향분석은 RCT 연구에서 무작위 분배 이후에 모든 대상자의 데이터를 결과에 포함하는 분석방법이다. RCT 연구의 결과는 일반화에 있어서 매우 높은 타당성을 갖는다. 이런 측면에서 중도 탈락을 포함한 모든 대상자의 데이터를 결과 분석에 포함하여야 그 결과를 실제 임상에 적용했을 때 중재의 효과가 예측 가능하기 때문이다. 이런 이유로 RCT 연구에 대한 질평가 도구들은 치료의향분석 실시여부를 확인하고 있다. 그럼에도 많은 연구자들은 치료의향분석의 이해도가 낮아 잘못 활용하고 있거나 활용하지 않는 경우가 많다. 결론 : 본 고찰 연구를 통해 국내 많은 연구자들이 치료의향분석방법을 정확하게 이해하고 올바르게 활용하여 RCT 연구에 반영할 것을 기대한다.

• 대한한의학방제학회지
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• 제28권2호
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• pp.199-209
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• 2020

Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I²=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

• Korean Journal of Acupuncture
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• 제24권3호
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• 대한약침학회지
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• 제18권1호
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• pp.79-85
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• 2015

Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.