• Title/Summary/Keyword: pilot trial

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Efficacy of Acupuncture in Treating Upper Abdominal Pain in Cancer Patients: Study Protocol for A Randomized Controlled Pilot Clinical Trial (암환자의 상복부 통증 치료에 대한 침의 효과: 무작위배정 대조군 연구 예비임상시험 프로토콜)

  • Jung, Jin-Yong;Lee, Hyun-Jong;Seo, Jung-Chul;Min, Bo-Mi;Cho, Min-Su;Shin, Im-Hee;Roh, Woon-Seok;Kwak, Min-Ah
    • Korean Journal of Acupuncture
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    • v.31 no.1
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    • pp.33-39
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    • 2014
  • Objectives : This study was designed to evaluate the feasibility of further acupuncture research as an effective and safe treatment for reducing cancer-related upper abdominal pain in patients treated with Neurolytic celiac plexus block(NCPB). Methods : This study is a randomized controlled pilot clinical trial of 3-week duration. Fourteen patients will be recruited and randomly allocated to 2 groups: an acupuncture plus NCPB group(experimental group) and a NCPB group(control group). All patients will undergo one session of NCPB, but only the experimental group will receive three acupuncture sessions a week for 2 weeks(6 in total). The primary outcome will be measured using the visual analogue scale, and the secondary outcome will be measured using the Painvision system and the consumption of additional analgesics. Assessments will be made at baseline and at 1, 2, and 3 weeks thereafter(that is, the 3-week assessment will be made 1 week after treatment cessation). Conclusions : This clinical trial will inform the design of a full-scale trial. The outcomes will provide information to facilitate the incorporation of acupuncture into existing pain management methods such as NCPB in the treatment of cancer-related upper abdominal pain patients.

Strategy on Production and Digitalization of Thematic Maps (공통주제도의 수치지도제작사업 추진방안에 관한 연구)

  • 김영표;조윤숙
    • Spatial Information Research
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    • v.5 no.1
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    • pp.43-59
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    • 1997
  • There are currently more than tens of thematic maps in Korea. Among them, there are some thematic maps which are used by one organization only by which was made, and there are common thematic maps which are used by several organizations. In this study, among many kinds of common thematic maps which are currently used, the common thematic maps which will be digitized for parts of NGIS project were chosen and the priority of project was established. After selecting five maps from the common thematic maps classified as the first ranking, current land use map, parcel-address map, administrative boundary map, urban planning map and road map, the area of CheJoo Island was digitized as a pilot project. Through the pilot project of CheJoo Island, the level of application was verified, and the method was presented in order to reduce the trial and error in the process of this production after analyzing the matter from the pilot project. The direction for digitizing common thematic maps was presented based on the result of the pilot project, in addition to, the detail plan was established after deciding the number of people needed, the amount of money spent, and the period needed for making digital maps nationwide.

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The effect of balance training with plantar flexor stretching on range of motion, balance, and gait in stroke patients: a randomized controlled pilot trial

  • Park, Ki-Suk;Choi, Jong-Duk
    • Physical Therapy Rehabilitation Science
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    • v.4 no.2
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    • pp.66-72
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    • 2015
  • Objective: The aim of this study was to investigate the effect of balance training with plantar flexor stretching on ankle dorsi flexion range of motion (ROM), balance, and gait ability in stroke patients. Design: A randomized controlled pilot trial. Methods: Thirty stroke patients volunteered to participate in this study. The subjects were randomly allocated to two groups: the experimental group (n=15) received the neurodevelopment therapy plus balance training with plantar flexor stretching for 20 minutes in one session. The control group (n=15) received the same neurodevelopment therapy plus plantar flexor static stretching for 20 minutes in one session. Both groups underwent sessions four times a week, for a total of 4 weeks. Measurements included passive range of motion (PROM), active range of motion (AROM) of ankle dorsiflexion using a goniometer, timed up and go (TUG), the functional reaching test (FRT), and the 10 m walk test (10 MWT). Results: There were significant improvements in AROM and PROM of ankle dorsiflexion, TUG, and FRT scores after the intervention in the experimental group (p<0.05). However, the control group showed no statistically significant differences except for PROM of ankle dorsiflexion. The experimental group showed a significant improvement in PROM, TUG, and FRT scores compared to the control group (p<0.05). Conclusions: Balance training with plantar flexor stretching improves ankle dorsiflexion ROM and balance ability in patients with stroke. Therefore, this therapeutic intervention will be effective for rehabilitation of stroke patients in the clinical setting.

Acupuncture for Subacute and Chronic Post-thoracotomy Pain in Patients with Traumatic Multiple Rib Fractures: A Study Protocol for a Randomised-controlled, Two-arm, Parallel Design, Pilot Trial

  • Kim, Kun Hyung;Cho, Hyun Min;Lee, Chan Kyu;Seok, JunePill;Kim, Seon Hee;Kim, Jung-Eun;Shin, Yu Kyung;Kim, Min Kyung
    • Journal of Acupuncture Research
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    • v.35 no.2
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    • pp.95-100
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    • 2018
  • Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

Effect of E10 on Relief of Cervical Myalgia; One Group Pre-Post, Pilot Trial Study (E10의 경항부 근육통 완화에 대한 효과; 전-후 비교, 예비 임상 연구)

  • Jung, Dong-Hoon;Kim, Hye-Jung;Kim, Jung-Sup;Lee, Gui-Sun;Park, Won-Hyung;Cha, Yun-Yeop
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.3
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    • pp.119-128
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    • 2016
  • Objectives The purpose of this study is to investigate the efficacy of E10 on the relief of cervical myalgia. Methods This study is a one group pre-post, pilot trial test. After the approval of institutional review board (IRB), we have recruited 25 patients suffering from cervical myalgia. 23 patients (2 patients dropped out) was treated by using E10 on the cervical muscle and acupuncture points, three times a week for a total of two weeks from February 2016 to April 2016. Evaluations of VAS for bothersomeness of neck pain (VASB), VAS for pain intensity (VASP), NDI, SF-36, X-ray, thermography, etc. before and 1 week after treatment were carried out. The primary outcome measure was the VASB, measured 1 week after the end of the therapy. Results VASB scores was significantly decreased from $72.5{\pm}9.9$ to $50.4{\pm}9.9$. VASP scores was significantly decreased from $71.5{\pm}10.5$ to $48.5{\pm}18.3$. Results showed significant improvements in VASB, VASP, NDI, SF-36 from the baseline. However, in X-ray, thermography, there was no singnificant difference. Conclusions This study demonstrates the effectiveness of E10 treatment for relieving cervical myalgia.

Observation on Change of Body Temperature for Patients with Low Back Muscular Pain after Electromagnetic Theraphy: a Randomized, Patient-assessor Blind, Placebo-controlled, Pilot Trial Study (자기를 이용한 경락 자극요법 시행 후 요부근육통 환자의 체열변화 관찰: 무작위배정, 환자-평가자 눈가림, 위기기 대조군, 예비 임상 연구)

  • Cho, Woong-Hee;Park, Won-Hyung;Cha, Yun-Yeop;Sun, Seung-Ho;Lee, Seon-Goo
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.4
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    • pp.145-156
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    • 2011
  • Objectives: This study was resigned to observe change of body temperature for patients with low back muscular pain after NUGA MRT-II(pulsed electromagnetic therapy) treatment. Methods: This study was a randomized, patient-assessor blind, placebo-controlled, pilot trial study. After the approval of institutional review board(IRB), we have recruited 38 patients suffering from low back muscular pain and divided them into two groups randomly: the treatment group and control group. To the treatment group, NUGA MRT-II was practiced and to the control group sham device was practiced and their low back muscles and acupuncture points three times a week for 2 weeks from February 2011 to May 2011. After 1 week of last treatment, We compared body temperature of two groups. Results: 1. There was significant decrease of body temperature on both Shinsu(BL23), Chishil(BL52), Kwanwonsu(BL26) acupunture points for the treatment group. 2. There was no difference in the decrease of body temperature between treatment group and control group except. Left Kwanwonsu(BL26). Conclusions: We found out that treatment of NUGA MRT-II on low back muscular pain can reduce the temperature of low back.

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.

The effect of single trial transcutaneous electrical nerve stimulation on balance and gait function in elderly people with dementia: a pilot study

  • Jung, Ju Yeon;Jung, Jin-Hwa;Hahm, Suk-Chan;Jung, Kyoungsim;Kim, Sung-Jin;Suh, Hye Rim;Cho, Hwi-young
    • Physical Therapy Rehabilitation Science
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    • v.6 no.2
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    • pp.59-64
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    • 2017
  • Objective: Elderly people with dementia experience not only cognitive dysfunction but also motor function deficits, such as balance and gait impairments. Recently, transcutaneous electrical nerve stimulation (TENS) has been used to reduce pain as well as to control muscle spasm, spasticity and motor performance in various types of subjects. The purpose of this study determined the effect of a single trial TENS on balance and gait function in elderly people with dementia. Design: A randomized controlled trial. Methods: Twenty-two subjects with dementia were assigned to the TENS group (n=12) and ten subjects were assigned to the control group (n=10) randomly. Subjects were classified into two groups: the TENS group (n=12) and the placebo-TENS group (n=10). The TENS group had electrical stimulation applied on the calf muscle for 15 minutes, while the placebo-TENS group had not received real electrical stimulation. The timed up and go test (TUG) and functional reach test (FRT) were used to measure the balance function, and the 10 meters walk test (MWT) and 6MWT were used to assess gait ability. All tests were performed before and after intervention under a single-blinded condition. Results: After intervention, there were significant improvements in TUG, FRT, 10MWT, and 6MWT results in the TENS group (p<0.05), while the placebo-TENS group did not show significant changes in all outcome measurements. There were also differences in all tests between the two groups at post-measurements (p<0.05). Conclusions: This study demonstrated that a single trial TENS application on the calf may be used to improve balance and gait function in elderly people with dementia.

Nutritional Intake and Timing of Initial Enteral Nutrition in Intensive Care Patients: A Pilot Study (중환자실 환자의 경관영양 공급시기에 따른 영양섭취양상: 예비연구)

  • Kim, Hyunjung
    • Korean Journal of Adult Nursing
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    • v.25 no.4
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    • pp.444-453
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    • 2013
  • Purpose: The purpose of this study was to describe the differences between early and delayed enteral nutrition on nutritional intake. Methods: A pilot cohort study was conducted with 45 critically ill adult patients who had a primary medical diagnosis. Energy prescribed and received were collected during the four days after initiation of enteral nutrition. Adequate feeding was defined as the energy intake more than 90% of required energy. Results: A total of 23 patients (52%) were received early enteral nutrition (within 48 hours of admission). Energy intake of early enteral nutrition was less than intake of delayed enteral nutrition during the four days of the study. Although the difference on day one was significantly greater than the differences on day two, the differences on day two were not different from days three or four. No statistical differences in the adequacy of nutritional intake were found between patients in the early and the delayed group. Conclusion: In critically ill patients receiving early enteral nutrition, more aggressive administration from the beginning will improve the nutritional intake. Additional studies including a large multi-centre, randomized clinical trial are recommended.

Application of Taguchi's Robust Design Method in Optimization of Measuring Electrical Properties on Acupoints: A Pilot Study (Taguchi 실험계획법을 이용한 경혈점의 피부전기특성 최적화조건 선정 : A Pilot Study)

  • Nam, Tong-Hyun;Shin, Sang-Hoon
    • Korean Journal of Acupuncture
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    • v.25 no.3
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    • pp.15-27
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    • 2008
  • Objectives : The objective of the current study is to optimize an acupoint electrical property measurement system by using the procedures and strengths of the Taguchi method. Methods : Taguchi method was applied in the optimization of the acupoint electrical property measurement system, as in the following steps: (1) determine evaluation index; (2) execute the 1st gage R&R; (3) identify controllable and uncontrollable factors; (4) design Taguchi crossed array layout; (5) execute experiments according to trial conditions; (6) analyze testing results; (7) determine optimum run; (8) execute the 2nd gage R&R; (9) confirm optimum run. Results : The results showed that electrodes with larger diameter and efferent electric current, with music played, can produce the larger different electrical conductivity between the acupoints and the non-acupoints under various conditions. Taguchi process optimization improved repeatability and reproducibility of the acupoint electrical property measurement system. Conclusions : In the optimized condition, repeatability and reproducibility of the acupoint electrical property measurement system was acceptable.

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