• 제목/요약/키워드: randomized clinical trial

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만성 경항통 환자에 대한 근위취혈과 원위취혈 침치료 효과 비교연구 (A Randomized Clinical Trial of Local Acupoints Compared with Distal Acupoints in Chronic Neck Pain Patients)

  • 김소정;장진영;김남식;김용석;남상수
    • Journal of Acupuncture Research
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    • 제28권5호
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    • pp.57-64
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    • 2011
  • Objectives : The purpose of this study is to compare the efficacy after acupuncture on local acupoints group and distal acupoints group for chronic neck pain. Design : A randomized, crossover clinical trial. Methods : From 15st, September 2010 to October 30th, 2010. 20 patients with chronic neck pain were randomly assigned to either group A or group B. Group A received acupuncture at local acupoints then after 1 week washout period acupuncture at distal acupoints. Group B received the treatment in reverse order. To evaluating efficiency and satisfaction, visual analog scale(VAS), neck disability index(NDI), cranio-cervical flextion test(C-CFT) and five-point likert scale were measured before and after each treatment. Results : Patients in local acupoints group experienced greater improvement than distal acupoints group in VAS. Both local acupoints group and distal acupoints group showed significant improvement in NDI but not in C-CFT and the NDI score change comparison between the two groups had no significance. Local acupoints group showed more effective than distal acupoints group on five-point likert scale. Conclusions : Local acupoints is more effective than distal acupoints in controlling pain in chronic neck pain.

침 임상연구에 사용된 거짓침의 분석 (Review and Analysis of Sham Acupuncture in Acupuncture Clinical Trials)

  • 장진영;김소정;김남식;남상수;김용석
    • Journal of Acupuncture Research
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    • 제28권5호
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    • pp.29-38
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    • 2011
  • Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

Effects of single-dose, low-level laser therapy on pain associated with the initial stage of fixed orthodontic treatment: A randomized clinical trial

  • Qamruddin, Irfan;Alam, Mohammad Khursheed;Abdullah, Habiba;Kamran, Muhammad Abdullah;Jawaid, Nausheen;Mahroof, Verda
    • 대한치과교정학회지
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    • 제48권2호
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    • pp.90-97
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    • 2018
  • Objective: The aim of this study was to assess the analgesic effect of a single application of low-level laser therapy (LLLT) on spontaneous pain and pain on chewing after placement of initial archwires. Methods: Forty-two patients (26 women, 16 men) were randomly recruited for this split-mouth randomized clinical trial. Each patient received super-elastic nickel-titanium (NiTi) initial archwires (0.012, 0.014, 0.016, and 0.018-inch [in]) in the maxilla for leveling and alignment for an interval of 4 weeks between archwires. One side of the mouth was randomly designated as experimental, while the other side served as placebo. After insertion of each archwire, the experimental side was irradiated with a diode laser for 3 seconds each on 5 points facially and palatally per tooth, from the central incisor to first molar. On the placebo side, the laser device was held the same way but without laser application. A numerical rating scale was used to assess the intensity of spontaneous and masticatory pain for the following 7 days. The Mann-Whitney U test was used to compare pain scores between sides. Results: Patients in the LLLT group exhibited significantly lower mean scores for spontaneous pain after insertion of the initial two archwires (0.012-in and 0.014-in NiTi; p < 0.05), while there was no significant difference for 0.016-in and 0.018-in wires between the LLLT and placebo groups. LLLT significantly reduced chewing pain scores (p < 0.05) for all archwires. Conclusions: A single dose of LLLT considerably lessened postoperative pain accompanying the placement of super-elastic NiTi wires for initial alignment and leveling.

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.

Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial

  • Yazdchi, Roya;Gargari, Bahram Pourghassem;Asghari-Jafarabadi, Mohammad;Sahhaf, Farnaz
    • Nutrition Research and Practice
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    • 제10권3호
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    • pp.328-335
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    • 2016
  • BACKGROUND/OBJECTIVES: Vitamin D plays an important role in the etiology of gestational diabetes mellitus (GDM). This study evaluated the effect of vitamin D supplementation on metabolic indices and hs-C-reactive protein (CRP) levels in GDM patients. SUBJECTS/METHODS: The study was a randomized, placebo-controlled, double-blinded clinical trial. Seventy-six pregnant women with GDM and gestational age between 24-28 weeks were assigned to receive four oral treatments consisting of 50,000 IU of vitamin $D_3$ (n = 38) or placebo (n = 38) once every 2 weeks for 2 months. Fasting blood glucose (FG), insulin, HbA1c, 25-hydroxyvitamin D, lipid profile, hs-CRP, and homeostasis model assessment-insulin resistance (HOMA-IR) were measured before and after treatment. Independent and paired t-tests were used to determine intra- and intergroup differences, respectively. ANCOVA was used to assess the effects of vitamin D supplementation on biochemical parameters. RESULTS: Compared with the placebo group, in the vitamin D group, the serum level of 25-hydroxyvitamin D increased (19.15 vs. -0.40 ng/ml; P < 0.01) and that of FG (-4.72 vs. 5.27 mg/dl; P = 0.01) as well as HbA1c (-0.18% vs. 0.17%; P = 0.02) decreased. Improvements in the lipid profiles were observed in the vitamin D group, but without statistical significance. Significant increases in concentrations of hs-CRP, FG, HbA1c, total cholesterol, and LDL cholesterol were observed in the placebo group. No significant change in fasting insulin and HOMA-IR was observed in either group. CONCLUSIONS: In GDM patients, vitamin D supplementation improved FG and HbA1c but had no significant effects on lipid profile or hs-CRP.

가상현실기반 재활프로그램이 뇌졸중환자의 균형에 미치는 영향 : 국내연구에 대한 메타분석 (The Effect of Virtual Reality Based Rehabilitation Program on Balance of Patient with Stroke: A Meta-analysis of Studies in Korea)

  • 노정석
    • 대한물리치료과학회지
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    • 제24권1호
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    • pp.59-68
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    • 2017
  • Purpose : The aims of this study was to conduct a systematic literature review with meta-analysis to investigate the effect of virtual reality based rehabilitation program on balance of patient with stroke in Korean studies. Method : The studies for analysis were searched in electronic databases(Research Information Sharing Service; RISS, Korean Studies Information Service; KISS, DBpia, e-articles, National Assembly Library). The key words for search were 'virtual reality', 'stroke', and 'balance' and only randomized controlled trials and clinical controlled trials were included. Of 40 studies identified in the search, 20 studies met the criteria of this study and included in this meta-analysis. Result : The results were as follows: 1) The overall effect size of virtual reality based rehabilitation program was 0.557(95% critical interval; 0.340~0.774). 2) In the analysis of sub-categorical variables, effect size was as follows; the commercial game type(0.621) > virtual environment type(0.335); the dynamic balance measurement(0.750) > static balance measurement(0.226); randomized controlled trial(0.653) > clinical controlled trial(0.275); and thesis type(0.706) > article of journal type(0.339). 3) In the analysis of sub-continuous variables, as time of program(per session) increased, the balance increased(p<0.05). Conclusion : The results of this study showed that virtual reality based rehabilitation program moderately improves the balance of stroke patient. Further studies are recommended to investigate the effect of sub-variables related to virtual reality programs on motor functions of patient with stroke.

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오타고운동 기반 낙상예방교육활동이 아급성 뇌졸중 환자의 균형, 낙상 효능감 및 일상생활동작능력에 미치는 영향: 무작위 대조군 임상 연구 (The effect of otago exercise-based fall prevention education activities on balance, fall efficacy and activities of daily living in the subacute stroke patients: A randomized controlled clinical trial)

  • 윤현식;한규범;오승인;이다비;송하희;송정은;차영주
    • 대한물리치료과학회지
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    • 제27권1호
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    • pp.1-8
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    • 2020
  • Background: This study analysed the effect of the fall prevention education activities on balance, fall efficacy, activities of daily living (ADL) of sub-acute stroke patients. Design: Randomized controlled trial. Methods: The subjects of the study were 24 subacute patients, who have onset period of less than 6 months. They are randomly allocated in the conventional therapy group (n=12) and fall prevention education group (n=12) and observed with frequency for 5 times a week for four weeks. Measuring took place before and after the experiment leading to following results of the Fall efficacy scale (FES), Berg balance scale (BBS) and Functional Independence Measure (FIM). Results: FES, BBS and FIM score was significantly greater in the post-test than in the pre-test in both groups (p<0.01). Independent t-test confirmed that the fall prevention education group showed much greater improvement change in the FES, BBS and FIM score than conventional therapy group (p<0.05). Conclusion: The present study demonstrated the importance of clinical contribution of the fall prevention education in the individuals with subacute stroke patients to the balance, fall efficacy and ADL following the stroke rehabilitation.

A randomized clinical trial to evaluate and compare the efficacy of triphala mouthwash with 0.2% chlorhexidine in hospitalized patients with periodontal diseases

  • Naiktari, Ritam S.;Gaonkar, Pratima;Gurav, Abhijit N.;Khiste, Sujeet V.
    • Journal of Periodontal and Implant Science
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    • 제44권3호
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    • pp.134-140
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    • 2014
  • Purpose: Triphala is a combination of three medicinal plants, extensively used in Ayurveda since ancient times. Triphala mouthwash is used in the treatment of periodontal diseases because of its antimicrobial and antioxidant properties. The aim of this study is to compare the efficacy of triphala mouthwash with 0.2% chlorhexidine in hospitalized periodontal disease patients. Methods: In this double-blind, randomized, multicenter clinical trial, 120 patients were equally divided into three groups. Patients in group A were advised to rinse their mouths with 10 mL of distilled water, group B with 0.2% chlorhexidine, and group C with triphala mouthwash for 1 minute twice daily for two weeks. The plaque index (PI) and the gingival index (GI) were recorded on the first and the fifteenth day. Results: There was no significant difference when the efficacy of triphala was compared with 0.2% chlorhexidine in hospitalized patients with periodontal disease. However, a statistically significant difference was observed in PI and GI when both group B and group C were compared with group A and also within groups B and C, after 15 days (P<0.05). Conclusions: The triphala mouthwash (herbal) is an effective antiplaque agent like 0.2% chlorhexidine. It is significantly useful in reducing plaque accumulation and gingival inflammation, thereby controlling periodontal diseases in every patient. It is also cost effective, easily available, and well tolerable with no reported side effects.

Post-operative analgesia of 2% lignocaine with or without magnesium sulfate for inferior alveolar nerve block in symptomatic mandibular molars - a randomized double blind controlled clinical trial

  • Chandrasekaran, Charanya;Vijay, Amirtharaj L;Sekar, Mahalaxmi;Mary, Nancy S
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권3호
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    • pp.147-154
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    • 2020
  • Background: Single inferior alveolar nerve block is ineffective in achieving adequate pulpal anesthesia in 30-80% of patients due to anatomical variations, local tissue pH, central sensitization, and several factors. Various supplementary techniques and combination of adjuvants with lignocaine are used to overcome these failures. Magnesium sulfate (MgSO4), one such adjuvant, acts at the N-methyl-D-aspartate glutamate receptor resulting in effective anesthesia. The aim of this prospective, randomized, double-blind, clinical controlled trial was to evaluate the onset, anesthetic efficacy, duration and post-operative analgesia of 2% lignocaine with and without the addition of MgSO4 in patients with symptomatic irreversible pulpitis and apical periodontitis. Methods: Fourty-two patients were randomly divided into three groups: 2% lignocaine (group 1) and 2% lignocaine with MgSO4 (75 mg) and (150 mg) in groups 2 and 3, respectively. Pre-operative vitals and Heft Parker-Visual Analogue Scale (HP-VAS) pain scores were recorded. The onset of anesthesia, anesthetic efficacy, and duration of anesthesia were evaluated post administration of the local anesthetic solution. The post-operative analgesia was examined at intervals of 2, 6, 12, 24, and 48 h. Results: Administration of 150 mg MgSO4 hastens the onset of anesthesia (1.29 min) and produces better anesthetic efficacy (3.29 HP-VAS) compared to group 2 (2.07 min and 9.14 HP-VAS) and group 1 (3.29 min and 35.79 HP-VAS), respectively. The duration of anesthesia was significantly higher in group 3 (247.07 min) compared to that of groups 2 and 1 (190 min and 110.21 min) with P < 0.05. Conclusion: Combining 75 mg or 150 mg of MgSO4 with lignocaine is more effective than 2% lignocaine and 75 mg of MgSO4 is adequate for endodontic procedures.

Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

  • Hajizadeh, Hila;Nemati-Karimooy, Atefeh;Majidinia, Sara;Moeintaghavi, Amir;Ghavamnasiri, Marjaneh
    • Restorative Dentistry and Endodontics
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    • 제42권3호
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    • pp.168-175
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    • 2017
  • Objectives: This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS) after periodontal surgery. Materials and Methods: Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil $S^3$ Bond (Kuraray Dental), G2: Gluma Desensitizer (Heraeus Kulzer), and G3: placebo (water). The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0), 1 day after treatment (T1), after 1 week (T2), and 1 month (T3) according to visual analog scale (VAS). Results: Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions: Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil $S^3$ Bond can have some benefits.