• Title/Summary/Keyword: Clinical Trial Protocol

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Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • v.23 no.6
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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Clinical outcomes of three- or five-day treatment with clomiphene citrate combined with gonadotropins and a timed intercourse cycle in polycystic ovary syndrome patients

  • Bae, Sung-Ah;Joo, Jong-Kil;Choi, Jong-Ryeol;Kim, Sun-Suk;Lee, Kyu-Sup
    • Clinical and Experimental Reproductive Medicine
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    • v.42 no.3
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    • pp.106-110
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    • 2015
  • Objective: This study aimed to investigate the effect of a new clomiphene citrate (CC) regimen on preventing thin endometrial lining in polycystic ovary syndrome (PCOS) patients receiving CC plus gonadotropin treatment with a timed intercourse cycle. Methods: A total of 114 women with PCOS were included in this trial. Patients were divided into two groups and treated in accordance with the controlled ovarian stimulation (COS) protocol. In group A, 104 COS cycles in 67 patients were included, and in each cycle 150 mg CC was given for three days, starting from day 3. In group B, 69 COS cycles in 47 patients were included, in which 100 mg CC was given for five days, starting from day 3. The thickness of the endometrium was measured on the day of human chorionic gonadotropin (hCG) injection. Timed intercourse was recommended at 24 and 48 hours after the hCG injection. Results: Additional doses of human menopausal gonadotropin and the number of days of hCG administration were not significantly different between the two groups. Endometrial thickness on the day of hCG administration was significantly larger in group A than group B (4$9.4{\pm}2.1mm$ vs. $8.5{\pm}1.7mm$, p=0.004). The pregnancy rate was significantly higher in group A than in group B (38.4% vs. 21.7%, p=0.030). Conclusion: Three-day CC treatment resulted in a significantly higher pregnancy rate than the standard five-day CC treatment in a timed intercourse cycle in PCOS patients. Facilitating adequate endometrial growth via the early discontinuation of CC might be a crucial factor in achieving a higher pregnancy rate.

The Use of Ojeok-san in Low Back Pain Patients : Results of a Telephone Survey (요통진료 및 오적산 사용현황파악을 위한 전화설문조사)

  • Shin, Kyung-Min;Jang, Min-Gee;Kim, Eun-Jung;Kim, Sun-Woong;Lee, Jae-Dong;Kim, Kap-Sung;Lee, Seung-Deok
    • Journal of Acupuncture Research
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    • v.27 no.2
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    • pp.71-78
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    • 2010
  • Objectives : This survey was accomplished to find out how Korean medical doctors take Ojeok-san prescriptions for low back pain in clinical practice. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. 306 persons having more than 5 years experience were randomly selected from a list of Korean medical doctors. Telephone interviews with them were conducted by the well-trained interviewers between March 21 and April 4 in 2009 and the computerized data were analyzed by STATA 9.0 SE version(Stata Corp, Colleg Station Tex, USA) statistical program. Results : 1. 192 out of 306(65.1%) Korean medical doctors taked Ojeok-san prescriptions for musculoskeletal disorders patients and 183 out of 192(95.3%) Korean medical doctors taked Ojeok-san prescriptions for low back pain treatment. 2. The rate of low back pain patients, '20~30%' was 99 people(33.6%) and the rate of Ojeok-san prescriptions for low back pain treatment, 'below 10%' was 65 people(35.5%). 3. In Ojeok-san effect of low back pain treatment, 'greate effects' 29.5%, 'tolerable effects' 66.7%, 'no effects' 3.8% were selected. In granule extracts effect, 'similar to Original herbs' 9.8%, 'unlike to Original herbs' 90.2% were selected. Conclusions : In our telephone survey, Korean medical doctors taked Ojeok-san prescriptions for low back pain treatment. Further research on this issue is needed.

Occupational Therapy for Community Mobility in Stroke Patients : Systematic review (뇌졸중 환자의 지역사회이동을 위한 작업치료 중재: 체계적 고찰)

  • Jo, Eun-Ju;Kam, Kyung-Yoon;Chang, Moon-Young
    • The Journal of Korean society of community based occupational therapy
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    • v.8 no.3
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    • pp.77-89
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    • 2018
  • Objective : The purpose of this study was to analyze occupational therapy intervention on the community mobility for stroke patients, and to provide evidence of intervention in the clinical fields. Methods : A systematic review was executed according to the PRISMA checklist. The accessed database was PubMed, EMBASE, Cochrane Library (CENTRAL), ProQuest Dissertations & thesis (PQDT), RISS, and KoreaMed. We included the articles published from 2005 to September 2018. RoBANS checklist was used to evaluate the quality of the articles. Included articles, totally eight, were categorized according to the type of intervention. Results : The study design of the literature was varied from two-group randomized trial, quasi-experimental study, case-control trial, one group pre-post comparison study, and cross-sectional study. In the evidence level, 6 articles were included in level II (75%). The percentage of low risk of bias in each article ranged from 52.5%~87.5%. Four studies (50%) provided intervention based on virtual reality or virtual environment. The three (37.5%) provided intervention based on the protocol, and the other (12.5%) did wheelchair training. All studies reported significant effects of the intervention. Conclusion : This systematic review provided evidences to use proper intervention in the clinical fields. Various type of studies should be conducted to prove the effect of occupational therapy intervention for community mobility.

An Economic Evaluation of Thread Embedding Acupuncture for the Treatment of Lumbar Herniated Intervertebral Disc in a Randomized Controlled Clinical Trial

  • Kim, Ha-Na;Kim, Jun-Yeon;Park, Kyeong-Ju;Hwang, Ji-Min;Jang, Jun-Yeong;Jo, Min-Gi;Ko, Min-Jung;Chae, Sang-Yeup;Kim, Jung-Hyun;Goo, Bonhyuk;Park, Yeon-Cheol;Seo, Byung-Kwan;Baek, Yong-Hyeon;Nam, Sang-Soo
    • Journal of Acupuncture Research
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    • v.38 no.4
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    • pp.312-319
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    • 2021
  • Background: Lumbar herniated intervertebral disc (LHIVD) is a frequently presented condition/disease in Korean medical institutions. In this study, the economics of thread embedding acupuncture (TEA) was evaluated in a randomized controlled trial comparing TEA with sham TEA (STEA). Methods: This economic evaluation was analyzed from a limited social perspective, and the per-protocol set was from a basic analysis perspective. The cost-effectiveness analysis was based on the change in visual analog scale score, and the cost-utility analysis was based on the quality-adjusted life years. The final results were expressed as the average cost-effectiveness ratio and incremental cost-effectiveness ratio, and furthermore sensitivity analysis was performed to confirm the robustness of the results observed. Results: The cost-effectiveness analysis showed that TEA was 9,908 won lower than STEA, while the decrease in 100 mm visual analog scale score was 8.5 mm greater in the TEA group compared with the STEA group (p > 0.05). The cost-utility analysis showed that TEA was 9,908 won lower than STEA, while the quality-adjusted life years of TEA was 0.0026 years higher than STEA (p > 0.05). These results were robust in the sensitivity analysis, but were not statistically significant. Conclusion: In treating LHIVD, TEA appeared to have cost-effectiveness and cost-utility compared with STEA. However, there were no significant differences between the groups in terms of cost, effectiveness, and utility indicators. Therefore, results must be interpreted prudently; this study was the 1st to conduct an economic evaluation of TEA for LHIVD.

Efficacy and Safety of Miniscalpel Acupuncture in Knee Degenerative Osteoarthritis Patients: A Study Protocol for a Randomized Controlled Pilot Trial (퇴행성 슬관절염 환자에 대한 도침요법의 효능 및 안전성 연구: 임상예비연구)

  • Jun, Seungah;Park, Mu Seob;Oh, Se Jung;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Hwangbo, Min;Lee, Hyun-Jong;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.33 no.2
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    • pp.67-74
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    • 2016
  • Objectives : The Knee degenerative osteoarthritis patients are not satisfied with the conventional therapies of KDOA, which results in the use of alternative therapies. The miniscalpel acupuncture is effective in treating chronic soft tissue, releasing contractures. However, there is little scientific evidence supporting the use of miniscalpel acupuncture in knee degenerative osteoarthritis. This study was designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis patients. Methods : We describe the protocol for a randomized controlled pilot clinical trial of 5 weeks duration. Twenty patients will be recruited and randomly allocated to two treatment groups: miniscalpel acupuncture treatment(experimental group); and acupuncture and electro-acupuncture treatment(control group). Miniscalpel acupuncture will be performed once with a 1-week interval for 3 weeks. Electro-acupuncture will be administered twice per week for a period of 3 weeks. The primary outcomes will be measured by visual analogue scale and range of motion. The secondary outcomes will be short-form McGill Pain Questionnaire and Western Ontario and McMaster Universities Osteoarthritis Index. Both primary and secondary outcomes will be measured at baseline and at 1, 2, 3 and 5 weeks(i.e. 2 weeks after treatment completion). Conclusions : This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis.

Current situation of Translational research on Acupuncture, Moxibustion and Pharmacopuncture (침구와 약침에 대한 중개연구 현황)

  • Sin, Dae Chul;Song, Ho Sueb
    • Journal of Acupuncture Research
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    • v.33 no.2
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    • pp.109-116
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    • 2016
  • Objectives : Our primary objective lies in understanding the current landscape of translational research on acupuncture, moxibustion and pharmacopuncture. Methods : We searched our own selection of keywords of acupuncture, moxibustion and pharmacopuncture and translational research from three overseas databases (Pubmed, Scopus, Medicine) and four domestic databases (DBpia, KISS, Riss4u, Korea Med). Results : We have chosen 41 articles in total-40 articles on acupunture, 6 article on moxibustion(5 articles were duplicated in use in each category). Origin-wise, 48.8 %/24.8 %/17.0 % of our articles pool came from USA/China/Korea, respectively. UK, Austria, Thailand and Italy contributed the rest of our article pool. For those articles written in USA and China, review articles were the most common type. For the US articles, all 10 review articles were non-systematic reviews, while, for China's contribution, one out of 4 review articles were systematic review. Type-wise, our research pool's breakdown is as follows ; 17 review articles, 11 experimental research, 2 randomized controlled trials(RCT), 1 clinical trial, 4 conference reports, 1 letter, 1 study protocol and 4 uncategorized. Topic-wise, brain-neurology was most frequently referred with 8 articles, followed by parkinson's disease (3 articles) and epilepsy (2 articles). Conclusion : 1. In terms of research submission articles, Korea appears to be lacking translational research on acupuncture, moxibustion and pharmacopuncture, compared to USA and China, in our view. 2. Unlike the cases of USA and China, most of Korean translational research is limited to doing a T1 level of translational research. In order to bring bench-to-bedside to light. we believe, there should be more studies, and thereby a certain level of activation, to the T2 level of translational research in Korea. 3. Further, in our view there should be more efforts to improve article quality at the T1 level of translational research, which eventually becomes the fundamentals of the next level of research (i.e. T2 research), as well as to increase the number of research submissions, going forward.

Therapeutic Potential of Atopy-camp: A pilot study

  • Lee, Nam-Ryul;Kim, Hyung-Geug;Seo, Kyoung-Suk;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.6
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    • pp.40-46
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    • 2010
  • Objective: This study investigated the therapeutic possibility of natural therapy in atopy-camp for children with atopic dermatitis. Methods: 30 children (19 boys and 11 girls, median age 11.5 years, ranging from 9 to 15) participated in natural environment-based activities in a camp-village located in Geumsan-gun for five days. Assessment of symptom change was conducted by self-reporting numeric scale (NRS) for pruritus and sleeping difficulty, investigator global assessment (IGA), eczema area and severity index (EASI score), serum histamine and IgE concentration before and after the camp period. Statistical significance was analyzed by paired t-test. Results: NRS for pruritus ($4.7{\pm}2.0$ into $4.3{\pm}2.1$), sleeping difficulty ($3.1{\pm}2.1$ into $2.9{\pm}2.0$), and serum histamine concentration ($4.27{\pm}7.39$ mol / L into $3.21{\pm}6.08$ mol / L) showed positive changes but didn't reach statistical significance (p > 0.05). IGA ($3.8{\pm}0.9$ into $4.13{\pm}1.0$), while EASI score ($10.8{\pm}9.7$ into $9.1{\pm}9.2$) and IgE ($408{\pm}320$ IU / mL into $385{\pm}3.8$ IU / mL) were significantly improved (p < 0.01). Conclusions: In spite of the limitation of the clinical trial protocol, this study may provide the possibility of natural environment-based therapy for children with atopic dermatitis.

The 3-Dimensional Finite Element Analysis of Minimum Implant Structure for Edentulous Jaw (무치악에 대한 최소 임플란트의 구조물의 3차원 유한요소 해석)

  • Jang, In-Sik
    • Journal of the Korean Society for Precision Engineering
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    • v.25 no.2
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    • pp.148-155
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    • 2008
  • The aim of the study is to interpret the distribution of occlusal force by 3-dimensional finite element analysis of ISP(Implant Supported Prosthesis) supported by minimum number of implant to restore the edentulous patients. For this study, the Astra Tech implant system is used. Geometric modeling for 6 and 4 fixture ISP group is performed with respect to the bone, implant and one piece superstructure, respectively. Implants are arbitrarily placed according to the anatomical limit of lower jaw and for the favorable distribution of occlusal force, which is applied at the end of cantilever extension of ISP with 30mm. Element type is tetrahedral for finite element model and the typical mechanical properties, Young's modulus and Poisson's ratio of each material, cortical, cancellous bone and implant material are utilized for the finite element analysis. From this study, we can see the distribution of equivalent stress equal to real situation and speculate the difference in the stress distribution in the whole model and at each implant fixture, From the analysis, the area of maximum stress is distributed on distal contact area between bone and fixture in the crestal bone. The maximum stress is 53MPa at the 0.2mm area from the bone-implant interface in the maximum side for 300N load condition for 4 fixture case, which is slightly less than the stress calculated from allowable strain. This stress has not been deduced to directly cause the loss of crestal bone around implant fixture, but the stress can be much reduced as the old peoples may have lower chewing force. Thus, clinical trial may be performed with this treatment protocol to use 4 fixtured ISP for old patients.

The efficacy of low-level diode laser versus laser acupuncture for the treatment of myofascial pain dysfunction syndrome (MPDS)

  • Khalighi, Hamid Reza;Mortazavi, Hamed;Mojahedi, Seyed Masoud;Azari-Marhabi, Saranaz;Parvaie, Parvin;Anbari, Fahimeh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.1
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    • pp.19-27
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    • 2022
  • Background: Myofascial pain dysfunction syndrome (MPDS) is the most common type of temporomandibular disorder. This study compared the efficacies of low-level diode laser therapy (LLLT) and laser acupuncture therapy (LAT) in the treatment of MPDS. Methods: This double-blind randomized controlled clinical trial included 24 patients with MPDS who were randomly divided into two equally sized groups. Patients in the LLLT group received 12 sessions of low-level diode laser irradiation applied to the trigger points of the masticatory muscles during 1 month. The same protocol was also used in the LAT group according to the specific trigger points. We measured pain intensity and maximum mouth opening in both groups at baseline, during treatment, and 2 months after treatment completion. Results: The pain intensities decreased from 6.58±1.31 to 0.33±0.65 and from 7.08 ± 1.37 to 0 in the LLLT and LAT groups, respectively. The maximum mouth openings increased from 32.25 ± 8.78 mm to 42.58 ± 4.75 mm and from 33 ± 6.57 mm to 45.67 ± 3.86 mm in the LLLT and LAT groups, respectively. Pain intensity (P = 0.839) and level of maximum mouth opening (P = 0.790) did not differ significantly between the groups. Conclusion: Our results showed similar efficacy between LLLT and LAT in the treatment of MPDS signs and symptoms.