• 제목/요약/키워드: assessor blinded

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Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • 제37권2호
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

요추 추간판 탈출증 환자에 대하여 기타 한방치료를 병행한 가열식 화침과 일반침의 효능 비교 연구: 무작위배정, 평가자 맹검, 평행군 설계 (The Comparative Study on the Effect of Fire Needling Therapy and General Acupuncture with Other Korean Traditional Medical Treatment for the Patient with Lumbar Herniated Intervertebral Disc: A Randomized, Assessor Blinded, Two Arm Trial)

  • 정세호;성희진;임수지;이은용;이참결
    • Journal of Acupuncture Research
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    • 제32권4호
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    • pp.29-36
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    • 2015
  • Objectives : The purpose of this study is to compare the efficacy of fire needling therapy and general acupuncture for the patient with lumbar herniated intervertebral disc. Methods : We observed 20 lumbar herniated intervertebral disc patients from March, 2014 to October, 2015. This study was randomized and assessor blinded. The patients were divided into two groups: one group(group A) was treated by general acupuncture only, and the other group(group B) was treated by fire needling therapy and general acupuncture. We evaluated the treatment effect experienced by each group using the visual analogue scale(VAS) and Oswestry disability index(ODI). Results : 1. In group A, VAS and ODI from before treatment to treatment 4, 8, 12, 16 were significantly improved in statistics. 2. In group B, VAS from before treatment to treatment 4, 8, 12, 16 was significantly improved, but ODI was significantly improved in statistics only from before treatment to treatment 12, not in treatment 4, 8, 16. 3. As a result of comparisons between group A and B, there were no statistical significance in VAS and ODI. Conclusions : This study was not able to determine statistical significance between the group treated by general acupuncture only and the group treated by fire needling therapy and general acupuncture, so further studies are required in the future.

Cognitive function improvement effects of gintonin-enriched fraction in subjective memory impairment: An assessor- and participant-blinded placebo-controlled study

  • Rami Lee ;Han Sang Lee ;Won-Woo Kim ;Manho Kim ;Seung-Yeol Nah
    • Journal of Ginseng Research
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    • 제47권6호
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    • pp.735-742
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    • 2023
  • Background: Gintonin is a new material of ginseng that acts through the ginseng-derived lysophosphatidic acid (LPA) receptor ligand. The gintonin-enriched fraction (GEF) inhibits amyloid plaque accumulation in the cortex and hippocampus, improves cognitive dysfunction by increasing acetylcholine levels, and promoted hippocampal neurogenesis in an animal model of Alzheimer's disease. We evaluated the effect of the GEF on the cognitive performance of subjects with subjective memory impairment (SMI). Methods: In this eight-week, randomized, assessor- and participant-blinded, placebo-controlled study, participants with SMI were assigned to three groups receiving placebo, GEF 300 mg/day or GEF 600 mg/day. The Korean versions of the Alzheimer's Disease Assessment Scale (K-ADAS), Mini-Mental State Examination (K-MMSE), and Stroop color-word test (K-SCWT) were also evaluated along with the safety profiles. Results: One hundred thirty-six participants completed the study. After eight weeks, we analyzed intergroup differences in primary or secondary outcome score changes. When we compared the GEF group with the placebo group, we observed significant improvements in the K-ADAS and K-SCWT scores. The GEF group did not show a significant improvement in K-MMSE and BDI scores compared to the placebo group. No adverse events were observed in the gintonin and placebo groups for eight weeks. Conclusion: The GEF is safe and effective in improving subjective cognitive impairment related to both the K-ADAS and K-SCWT in this study. However, further large-scale and randomized controlled studies are warranted to secure other cognitive function tests besides the K-ADAS and K-SCWT, and to confirm the findings of the current study.

만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구 (Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study)

  • 공한미;전승아;정연중;김주란;이정희;이현종;박정아;김재수
    • Korean Journal of Acupuncture
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    • 제37권1호
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

Effects of Ankle and Hip Strategy Training on Improving the Center of Pressure Movements and Limits of Stability in Stroke Patients

  • Park, Shinjun;Park, Sunghyun;Kim, Yongyoun
    • 국제물리치료학회지
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    • 제10권3호
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    • pp.1823-1829
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    • 2019
  • Background: Stroke patients have leg muscle weakness and impaired balance resulting in compensatory changes. To restore balance in these patients, functional training using postural strategy is needed. Objective: To examine the effects of ankle and hip strategy training on the center of pressure (COP) movement and limits of stability (LOS) in standing posture in stroke patients. Design: The study was an assessor-blinded and randomized-controlled clinical trial. Methods: Thirty patients were randomly assigned to an ankle strategy training group and a ankle/ hip strategy training group. Patients in the ankle strategy training group underwent ankle strategy exercise for 30 min, and those in the ankle/ hip strategy training group underwent 15 min of ankle strategy exercise and 15 min of hip strategy exercise. Both groups underwent training thrice a week for four weeks. Forward, backward, paretic side, and non-paretic side COP movements and LOS were measured using BioRescue. Results: After the intervention, except for the backward area in the ankle strategy training group, the COP movement area and the LOS were significantly improved in both the groups. In addition, these improvements were significantly higher in ankle/ hip strategy training group than that in the ankle strategy training group. Conclusions: Ankle strategy training in addition to hip strategy training improves COP movement (forward-backward, paretic side area, and non-paretic side area) and LOS in stroke patients.

Effectiveness of graded motor imagery in subjects with frozen shoulder: a pilot randomized controlled trial

  • Gurudut, Peeyoosha;Godse, Apurva Nitin
    • The Korean Journal of Pain
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    • 제35권2호
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    • pp.152-159
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    • 2022
  • Background: Subjects with frozen shoulder (FS) might not be comfortable with vigorous physical therapy. Clinical trials assessing the effect of graded motor imagery (GMI) in FS are lacking. The aim of this study was to determine the effect of GMI as an adjunct to conventional physiotherapy in individuals with painful FS. Methods: Twenty subjects aged 40-65 years having stage I and II of FS were randomly divided into two study groups. The conventional physiotherapy group (n = 10) received electrotherapy and exercises while the GMI group (n = 10) received GMI along with the conventional physiotherapy thrice a week for 3 weeks. Pre- (Session 1) and post- (Session 9) intervention analysis for flexion, abduction, and external rotation range of motion (ROM) using a universal goniometer, fear of movement using the fear avoidance belief questionnaire (FABQ), pain with the visual analogue scale, and functional disability using the shoulder pain and disability index (SPADI) was done by a blinded assessor. Results: Statistically significant difference was seen within both the groups for all the outcomes. In terms of increasing abduction ROM as well as reducing fear of movement, pain, and functional disability, the GMI group was significantly better than control group. However, both groups were equally effective for improving flexion and external rotation ROM. Conclusions: Addition of GMI to the conventional physiotherapy proved to be superior to conventional physiotherapy alone in terms of reducing pain, kinesiophobia, and improving shoulder function for stage I and II of FS.

뇌졸중 환자에게 하지 근력강화 프로그램이 균형, 보행과 상지 기능에 미치는 효과 (The Effects of Lower Extremity Strengthening Program on Balance, Gait and Upper Limb Function in Patients with Stroke)

  • 김주오;이병희
    • 한국콘텐츠학회논문지
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    • 제20권6호
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    • pp.114-123
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    • 2020
  • 본 연구는 뇌졸중 환자에게 하지 근력강화 프로그램이 균형, 보행 및 상지 기능에 미치는 효과에 대해서 알아보았다. 신경계 손상 환자가 있는 병원을 기반으로 해서 하지 근력 강화에 대한 연구 방법을 만들어서 진행하였고, 무작위대조시험을 적용하였다. 24명의 뇌졸중 환자를 두 군으로 분류하였다. 하지 근력 강화 프로그램그룹 (Lower extremity strengthening program group, LESPG) (12명)과 트레드밀 훈련그룹 (Treadmill trainig group, TTG) (12명)으로 실험하였다. LESPG는 마비측에 하지 근력 강화프로그램을 수행하였다. TTG는 하루 30분 동안 트레드밀 운동을 적용하였다. 평가 도구는 일어나서 보행 검사(Timed Up and Go test, TUG), 기능적 보행평가 (Functional Gait Assessment, FGA) 및 뇌졸중 상지 기능검사(Manual Function Test, MFT)를 적용하였다. 균형, 보행 및 상지 기능에 대한 두 군 간의 TUG, FGA 및 MFT 점수는 LESPG가 TTG보다 유의한 차이가 있었다(p<.01). 4주간의 하지 근력강화 프로그램의 효과는 뇌졸중 후 편마비 환자의 균형, 보행 및 상지 기능에 효과가 있었다.

Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double-Blind Randomized Controlled Clinical Trial

  • Jafarpour-Sadegh, Farnaz;Montazeri, Vahid;Adili, Ali;Esfehani, Ali;Rashidi, Mohammad-Reza;Mesgari, Mehran;Pirouzpanah, Saeed
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권17호
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    • pp.7517-7522
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    • 2015
  • Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

Socket preservation using eggshell-derived nanohydroxyapatite with platelet-rich fibrin as a barrier membrane: a new technique

  • Kattimani, Vivekanand Sabanna;Lingamaneni, Krishna Prasad;Kreedapathi, Girija Easwaradas;Kattappagari, Kiran Kumar
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제45권6호
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    • pp.332-342
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    • 2019
  • Objectives: Socket grafting is vital to prevent bone resorption after tooth extraction. Several techniques to prevent resorption have been described, and various bone graft substitutes have been developed and used with varying success. We conducted this pilot study to evaluate the performance of nanohydroxyapatite (nHA) derived from chicken eggshells in socket preservation. Materials and Methods: This was a prospective, single center, outcome assessor-blinded evaluation of 23 sockets (11 patients) grafted with nHA and covered with platelet-rich fibrin (PRF) membrane as a barrier. Bone width and radiographic bone density were measured using digital radiographs at 1, 12, and 24 weeks post-procedure. Postoperative histomorphometric and micro-computed tomography (CT) evaluation were performed. The study protocol was approved by the Institutional Ethics Committee. Results: All patients had uneventful wound healing without graft material displacement or leaching despite partial exposure of the grafted socket. Tissue re-epithelialized with thick gingival biotype (>3 mm). Width of the bone was maintained and radiographic density increased significantly with a trabecular pattern (73.91% of sockets) within 12 weeks. Histomorphometric analysis showed 56.52% Grade 3 bone formation and micro-CT analysis revealed newly formed bone with interconnecting trabeculae. Conclusion: Use of a PRF membrane with nHA resulted in good bone regeneration in sockets. Use of a PRF membrane prevents periosteal-releasing incisions for primary closure, thereby facilitating the preservation of keratinized mucosa and gingival architecture. This technique, which uses eggshell-derived nHA and PRF membrane from the patient's own blood, is innovative and is free of disease transfer risks. nHA is a promising economic bone graft substitute for bone regeneration and reconstruction because of the abundant availability of eggshell waste as a raw material.

만성 요통 환자에서의 휴대용 저출력 레이저 치료기의 통증 및 기능 효과 (Efficacy of Portable Low Power Laser Therapy on Pain and Functions in Chronic Low Back Pain)

  • 조연욱;김태희;임오경;이주강;박기덕
    • Clinical Pain
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    • 제19권1호
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    • pp.1-7
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    • 2020
  • Objective: A prospective, assessor-blinded, randomized controlled trial was conducted in patients with chronic low back pain to evaluate the efficacy of portable low power laser therapy (LPLT) and the effect when combined with exercise therapy on pain and functions. Method: 60 patients were recruited and 56 patients, excluding 4 dropouts, were randomly allocated to the LPLT group (Group 1: 19 patients), placebo laser therapy with exercise group (Group 2: 18 patients), and LPLT with exercise group (Group 3: 19 patients). Laser therapy and exercise was performed five times a week for 4 weeks. Visual analogue scale (VAS), Schober test, lumbar range of motion (ROM) measures (flexion, extension and lateral flexion), Oswestry Disability index (ODI) were measured at baseline, at 4 weeks after intervention, and at 6 weeks after 2 weeks of no intervention. Results: Statistically significant improvements were noted in all group by time interaction with respect to all outcome parameters (p<0.05). All parameters in each group improved not only in the period of treatment (4 weeks), but also in the final evaluation (6 weeks) 2 weeks after the end of treatment. Post-hoc analysis showed statistically significant difference between the LPLT with exercise group and the other groups in all outcome parameters except for the ODI at 4 weeks and at 6 weeks. Conclusion: Portable LPLT is effective treatment in reducing pain and improving lumbar ROM and with exercise is more effective than laser or exercise monotherapy for the chronic low back pain patients.