• 제목/요약/키워드: Pilot clinical trial

검색결과 71건 처리시간 0.025초

췌장염 환자의 복통 호전을 위한 전침 및 이침 치료 예비 임상연구 프로토콜 (A Clinical Study of Electroacupuncture and Auricular Acupuncture for Abdominal Pain Relief in Patients with Pancreatitis: A Pilot Study)

  • 강하라;이연선;김혜련;김은정;김경호;김갑성;정찬영;이준규
    • Korean Journal of Acupuncture
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    • 제34권1호
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    • pp.47-55
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    • 2017
  • Objectives : The purpose of this study is to evaluate the feasibility of further acupuncture research as an effective alternative and safe treatment for abdominal pain control in patients with pancreatitis. Methods and Results : This study is an open-label, assessment-blind, parallel designed pilot clinical trial. Thirty participants will be assigned to the acupuncture group(n=15) and usual care group(n=15). All patients will receive the conventional standard-of-care(SOC) therapy, but only the experimental group will receive acupuncture therapy six times a week, and the duration of acupuncture therapy will be held up to 12 weeks or until the pains are to be resolved. For the conventional SOC therapy, painkiller will be given. In treatment group, the subjects will receive the identical SOC therapy in combination with electroacupuncture therapy on twelve acupuncture points(LI4, PC6, SP6, GB39, ST36, ST37), and auricular acupuncture therapy on five auricular acupuncture points(Sympathetic, Shen Men, Abdomen, Pancreas gall, and Spleen). The primary outcome will be measured using the visual analogue scale(VAS), and the secondary outcome will be measured using the painkiller demand, quality of life index and severity of pancreatitis by abdominal computed tomography(CT). Assessments will be made at baseline and at week 1, 4, 8 and 12. Results of abdominal CT will be evaluated at baseline and at week 12. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for abdominal pain in patients with pancreatitis.

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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    • 제4권2호
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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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    • 제35권2호
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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.

폐경 후 고혈압 전단계 및 1기 고혈압에 대한 침 치료 효과: 무작위 대조 예비연구 (Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: A Randomized Controlled Pilot Trial)

  • 김정은;최선미;최진봉;김형준;권오진;김재홍;박지은
    • Korean Journal of Acupuncture
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    • 제34권3호
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    • pp.116-125
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    • 2017
  • Objectives : The aim of this study was to assess the effectiveness of acupuncture in treating prehypertension and stage 1 hypertension in postmenopausal women. Methods : The study was a multi-center, four-arm, non-blinded, randomized clinical trial. Sixty participants were randomly assigned to experimental or control groups. The experimental groups received 10 acupuncture sessions over 4 weeks(Group A, n=20) or 20 sessions over 8 weeks(Group B, n=20) along with usual care. The acupoints were GB20, LI11, ST36, and SP6, bilaterally. The acupuncture groups were followed-up for an additional 12 weeks after acupuncture treatment. The control groups received usual care for 16 weeks(Group C, n=10) or 20 weeks(Group D, n=10). The outcomes were blood pressure, blood pressure control rates, lipid profile, and high-sensitivity C-reactive protein(hs-CRP). Results : After 4 weeks, DBP in the acupuncture groups(A+B) showed no significant decrease compared to the control group(C+D). However, after 8 weeks of acupuncture treatment, group B showed a significant decrease in DBP after acupuncture treatment and follow-up period compared to control group. Although there was no difference between the acupuncture and control groups in SBP after acupuncture treatment, group B showed a significant decrease in SBP compared to control group after follow-up period. Lipid profiles and hs-CRP did not differ significantly between acupuncture and control groups. Conclusions : Acupuncture treatment for 8 weeks showed the effect on prehypertension and mild hypertension. To verify the effect of acupuncture on blood pressure, rigorous trials including more participants are required.

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

  • 김현정
    • 성인간호학회지
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    • 제25권4호
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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.

노인에게 적용한 타이치운동의 논문분석 (Analysis of the Effectiveness of Tai Chi Exercise in Elderly)

  • 이혜영;김금자
    • 근관절건강학회지
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    • 제15권1호
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    • pp.5-23
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    • 2008
  • Purpose: This study aims to conduct a systematic review of the physical, psychosocial and physiological effects of Tai Chi exercise in elderly. Method: 37 articles from Medline search of foreign journals (1966-2006) were surveyed by the key words 'Tai Chi', 'Tai-chi program' and 'Tai-chi and elderly' limiting the range to age 65 or older, choosing clinical trial and randomized controlled trial research in English articles. Four articles were excluded due to methodological study, pilot study and review. The research was analyzed according to health status of the subjects, styles and forms of Tai Chi exercises, factors for physical, psychosocial and physiological measures. Result: A short forming Yang style was commonly used in chronic diseases and health for elderly. Variable outcome measures were used in Tai Chi studies relating to balance, muscle strength, walking and mobility, flexibility and cardiorespiratory function in physical measure, quality of life, depression, self-efficacy, health status, cognition and impact questionnaire in psychosocial measure, lipids, insulin resistance and hormone in physiological measure. Conclusion: Tai Chi exercise appears to have physical and psychosocial benefits and also appears to be safe for elderly and chronic diseases. It is suggested that future studies analyze statistical part of systematic reviews through meta analysis.

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The Effect of Adding Kami-guibi-tang to Acetylcholinesterase Inhibitor Treatment on the Cognitive Function of Mild Alzheimer's Disease Patients: Study Protocol of a Randomized, Placebo-Controlled, Double-Blind Pilot Trial

  • Yang, Seung-bo;Kim, Ha-ri;Shin, Hee-yeon;Kim, Jeong-hwa;Lee, Chang-woo;Jahng, Geon-ho;Park, Seong-uk;Ko, Chang-nam;Park, Jung-mi
    • 대한한방내과학회지
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    • 제41권3호
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    • pp.326-338
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    • 2020
  • Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

A Novel Implantable Cerebrospinal Fluid Reservoir : A Pilot Study

  • Byun, Yoon Hwan;Gwak, Ho Shin;Kwon, Ji-Woong;Kim, Kwang Gi;Shin, Sang Hoon;Lee, Seung Hoon;Yoo, Heon
    • Journal of Korean Neurosurgical Society
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    • 제61권5호
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    • pp.640-644
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    • 2018
  • Objective : The purpose of this pilot study was to examine the safety and function of the newly developed cerebrospinal fluid (CSF) reservoir called the V-Port. Methods : The newly developed V-Port consists of a non-collapsible reservoir outlined with a titanium cage and a connector for the ventricular catheter to be assembled. It is designed to be better palpated and more durable to multiple punctures than the Ommaya reservoir. A total of nine patients diagnosed with leptomeningeal carcinomatosis were selected for V-Port insertion. Each patient was followed up for evaluation for a month after the operation. Results : The average operation time for V-Port insertion was 42 minutes and the average incision size was 6.6 cm. The surgical technique of V-Port insertion was found to be intuitive by all neurosurgeons who participated in the pilot study. There was no obstruction or leakage of the V-Port during intrathecal chemotherapy or CSF drainage. Also, there were no complications including post-operative intracerebral hemorrhage, infection and skin problems related to the V-Port. Conclusion : V-Port is a safe and an easy to use implantable CSF reservoir that addresses problems of other implantable CSF reservoirs. Further multicenter clinical trial is needed to prove the safety and the function of the V-Port.

The Effects of Gabapentin in Treatment of Burning Mouth Syndrome: Retrospective Pilot Study

  • Heo, Jun-Young;Ok, Soo-Min;Jeong, Sung-Hee;Kim, Kyung-Hee;Ahn, Yong-Woo
    • Journal of Oral Medicine and Pain
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    • 제39권3호
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    • pp.96-99
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    • 2014
  • Purpose: The objective of this retrospective pilot study was to evaluate the effectiveness of Gabapentin in patients with primary burning mouth syndrome (BMS). Methods: Ten subjects were diagnosed with primary BMS (8 women and 2 men). The mean age was 60.1 years. They had clinical examination to exclude local factors such as the presence of Candida species, xerostomia, lichen planus, etc. They also underwent hematological examination to exclude secondary BMS due to systemic disorders. Pain was assessed by patients on an 11-point numerical rating score system (0 to 10). Gabapentin was administered at a starting dose of 300 mg/day, slowly titrated up to maximum of 1,800 mg/day. All patients were treated for 4 weeks. Results: One half of the patients (n=5) obtained reduction in pain over the treatment period. Four patients reported no reduction in pain symptoms. One patient reported that symptoms were worsening. The average pain score before the treatment was 6.3 and after the treatment was 5.25. No significant relationship was detected between pretreatment and posttreatment pain score. Only one patient noted mild side effect (dizziness). Conclusions: This retrospective pilot study provides no preliminary evidence that Gabapentin has effect in the management of BMS. However, further research (well-designed, randomized, and controlled trial with large sample) would be needed to investigate the efficacy of Gabapentin in treatment of BMS.

기능성 소화불량 환자에서 설태후박 및 흉늑각 측정의 진단적 가치 (Diagnostic Values of Tongue Coating Thickness and Sterno-costal Angle in Functional Dyspepsia)

  • 손지영;김진성
    • 대한한방내과학회지
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    • 제35권2호
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    • pp.157-174
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    • 2014
  • Objectives : The aims of this study were to evaluate the diagnostic values of tongue coating thickness and sterno-costal angle as the quantitative diagnostic indicators in functional dyspepsia. Methods : We surveyed 60 functional dyspepsia patients recruited by the clinical trial, 'Clinical Trial for Evaluation on Availability of tongue diagnosis system (CTS-1000) : a Pilot study'. The patients were classified into three groups according to Rome III criteria for functional dyspepsia, and categorized into five groups according to Instrument of pattern identification for functional dyspepsia. Nepean dyspepsia index-Korean version (NDI-K) score, tongue coating thickness (percentage of tongue coating by tongue diagnosis system (CTS-1000), and weight of tongue coating by microbalance), sterno-costal angle, duration of illness and body mass index (BMI) were investigated. Results : Among the 5 types by instrument of pattern identification for functional dyspepsia, a significant difference of percentage of tongue coating was found. Percentage of tongue coating and weight of tongue coating showed significant correlation with total NDI-K score. Sterno-costal angle showed strong positive correlation with BMI and also showed significant difference between the non-overweight (BMI<23, n=32) and overweight ($BMI{\geq}23$, n=28) groups. Conclusions : Tongue coating thickness showed its potential as a new quantitative diagnostic indicator of functional dyspepsia. Further studies on the sterno-costal angle are anticipated to evaluate its potential as a new quantitative diagnostic indicator.