• 제목/요약/키워드: randomized clinical trial

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A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds

  • Pak, Changsik;Park, Jihoon;Hong, Jinmyung;Jeong, Jaehoon;Bang, Saik;Heo, Chan Yeong
    • Archives of Plastic Surgery
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    • v.42 no.6
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    • pp.721-728
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    • 2015
  • Background We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests. Results Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane. Conclusions In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.

Randomized controlled clinical trial of oral health-related quality of life in patients wearing conventional and self-ligating brackets

  • Othman, Siti Adibah;Mansor, Noorhanizar;Saub, Roslan
    • The korean journal of orthodontics
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    • v.44 no.4
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    • pp.168-176
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    • 2014
  • Objective: The aim of this randomized controlled clinical trial was to compare oral health-related quality of life (OHRQoL) of patients treated with conventional, active self-ligating (ASL), and passive self-ligating (PSL) brackets in different therapeutic phases. Methods: Sixty patients (mean age 18.3 years; 29 males and 31 females) requiring orthodontic treatment were randomly and equally assigned to receive conventional (Victory Series), ASL (In-Ovation R), or PSL (Damon 3MX) brackets. OHRQoL was measured with a self-administered modified 16-item Malaysian version of the Oral Health Impact Profile for immediate (soon after the visit) and late (just before the subsequent visit) assessments of the bonding and activation phases. Data were analyzed with the Kruskal-Wallis and chi-square tests. Results: The PSL and ASL groups showed more immediate and late impacts in the bonding phase, respectively; the conventional group was affected in both the assessments. The first activation phase had similar impacts in the groups. After the second activation, the conventional group showed more immediate impacts, whereas the PSL and ASL groups had more late impacts. The commonly affected domains were "physical disability," "functional limitation," "physical pain," and "psychological discomfort." No significant differences in the prevalence and severity of immediate and late impacts on OHRQoL of the patients were noted in any therapeutic phase. Conclusions: No bracket system seems to ensure superior OHRQoL. This information could be useful for explaining the therapeutic phases, especially the initial one, and selecting the optimal bracket system based on the patient's preference.

Review of Clinical Research about the Treatment of Aphasia after Cerebrovascular Disease (뇌혈관질환 후 실어증의 한의학적 치료에 대한 국내 임상연구에 대한 고찰)

  • Koh, Ji-yoon;Son, Ah-hyun;Shin, Hyeon-su
    • The Journal of Internal Korean Medicine
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    • v.39 no.6
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    • pp.1105-1115
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    • 2018
  • Objectives: The aim of this review is to investigate clinical studies on Oriental medicine treatment for aphasia after cerebrovascular disease. Methods: Using the keywords 'Aphasia', 'Oriental medicine', 'Stroke' 'Cerebral infarction', 'Cerebral hemorrhage', and 'Clinic', we searched domestic databases, including "NDSL (National Discovery for Science Leaders)", "Korean Traditional Knowledge Portal", "OASIS (Oriental Medicine Advanced Searching Integrated System)", and "RISS (Research Information Sharing Service)". Each keyword was not searched individually, but combined in various ways. To investigate recent trends, we limited our search to papers published after 2000. Papers that did not include a specific treatment method or did not match the subject "Aphasia after stroke" were excluded. Results: Using the searching method, 13 studies were found. Of these, 12 studies were in the form of case reports, while one was in the form of a non-randomized controlled trial. These studies showed positive results for the use of Oriental medicine in terms of the Korean version of the Western Aphasia Battery (K-WAB), the evaluation form on functional performance capability and accuracy of articulatory organs developed by Lee, aphasia screening test refered in 'Assessment in Speech-Language Pathology' and adapted properly to Korean, the Communicative Ability in Daily Living Test (CADLT), the Korean Version-Boston Naming Test (K-BNT), and language assessment items included in CNS, and NIHSS. Conclusions: Of the 12 case reports, 11 studies showed positive results of the use of Oriental medicine for treatment of aphasia after cerebrovascular disease. However, more sophisticated and large-scale clinical research on aphasia should be conducted.

Effect of Paretic and Non-paretic Side Spine Taping on Balance Ability in Patients with Stroke

  • Cho, Yonghun;Park, Shinjun;Kim, Soonhee
    • Journal of International Academy of Physical Therapy Research
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    • v.10 no.2
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    • pp.1779-1784
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    • 2019
  • Background: A number of researchers have attempted to improve the balance of stroke patients, however there is still a question as to whether taping is effective in increasing balance. Objective: To determine the effect of paretic and non-paretic side taping on the balance ability in patients with stroke. Design: A single-blind randomized controlled trial Methods: This randomized single-blind controlled clinical trial with a repeated measures study included 45 subjects who were randomly assigned to paretic side taping groups (n=15), non-paretic side taping groups (n=15), and trunk exercise groups (n=15). Trunk exercise and paretic side taping groups had taping on the paralyzed erector spinae, while the non-paretic side taping group had taping on the non-paralyzed erector spinae. Trunk exercises were performed for 30 minutes to promote core muscles. The balance ability measured the center of pressure movement (paretic side, non-paretic side,forward, backward, limit of stability) in the sitting position. All measurements were evaluated using BioRescue. Results: All three groups showed significant increase in all variables after 4 weeks. The paretic and non-paretic side taping groups had a significant increase in all variables after 30 min of attachment. However, there was no significant difference among the three groups. Conclusions: Paralysis and non-paralysis taping improved the balance ability of patients with stroke in an immediate effect of 30 min. However, after 4 weeks of intervention, taping with trunk exercise did not differ from single trunk exercise. In future studies, various analyses need to be conducted through more diverse evaluations.

Comparison of the effects of transcutaneous electrical nerve stimulation, low level laser, and placebo treatment on temporomandibular joint disorders: a single-blind randomized controlled trial

  • Kim, Hyunjoong
    • Physical Therapy Rehabilitation Science
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    • v.9 no.4
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    • pp.244-251
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    • 2020
  • Objective: Physical therapy techniques are required for patients with temporomandibular joint disorder (TMD), but the effects of treatment have not been compared. Therefore, effects of transcutaneous electrical nerve stimulation (TENS) and low level laser (LLL), which are most commonly used interventions, were compared. Design: Randomized controlled trial. Methods: Thirty-six participants with pain in the temporomandibular joint were enrolled, and 12 participants were randomly assigned to either the TENS group, LLL group, or placebo group. Each intervention was performed for a total of 6 sessions for 2 weeks. For the evaluation of the participants, the mouth opening (MO), pressure pain threshold (PPT), and stress were measured at three time periods: baseline, post-test, and follow-up at 2 weeks. Results: Significant interaction between groups according to each evaluation point was found only in PPT-masseter (p<0.05). The evaluation time point at which a significant difference appeared was at the post-test and follow-up at 2 weeks time periods. As a result of the post-test, the LLL group showed a significant improvement compared to the TENS group (p<0.05), and at 2 weeks follow-up, the TENS group showed a significant improvement compared to the placebo group (p<0.05). Conclusions: In this study, an experiment was conducted to compare the treatment effects when TENS, LLL, and placebo were given to patients with TMD. In addition, by quantitatively presenting the effect size of each treatment, this study suggests clinical use of TENS and LLL treatment for TMD.

The effect of pre-cooling versus topical anesthesia on pain perception during palatal injections in children aged 7-9 years: a randomized split-mouth crossover clinical trial

  • Chilakamuri, Sandeep;SVSG, Nirmala;Nuvvula, Sivakumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.6
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    • pp.377-386
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    • 2020
  • Background: To compare pain perception during palatal injection administration in children aged 7-9 years while using pre-cooling of the injection site versus application of topical anesthesia as a pre-injection anesthetic during the six months. Method: A prospective randomized split-mouth crossover trial was conducted among 30 children aged 7-9 years, who received topical application of either a pencil of ice (test group) or 5% lignocaine gel (control group) for 2 min before injection. The primary and secondary outcome measures were pain perception and child satisfaction, measured by the composite pain score and the faces rating scale, respectively. Unpaired t-test was performed to determine significant differences between groups. Results: The test group had significantly lower pain scores for self-report and behavioral measures (P < 0.0001). The changes in physiological parameters at the baseline (P = 0.74) during (P = 0.37) and after (P = 0.88) the injection prick were not statistically significant. Children felt better by the pre-cooling method (P < 0.0001). Conclusion: Ice application using a pencil of ice for 2 min reduced pain perception significantly compared to the use of a topical anesthetic. Moreover, ice application was preferred by children.

Effects of a Cognitive Behavior Therapy Program for Patients with Fibromyalgia Syndrome: A Randomized Controlled Trial (섬유근통 증후군 환자를 위한 인지행동 프로그램의 효과: 무작위 대조군 전후실험설계)

  • Kong, Kyoung Ran;Lee, Eun Nam
    • Journal of Korean Academy of Nursing
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    • v.51 no.3
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    • pp.347-362
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    • 2021
  • Purpose: This study developed a cognitive behavioral therapy program aimed at altering the physical condition, emotions, and behaviors of fibromyalgia patients, and confirmed the program's clinical applicability. The program was developed by analyzing previous studies conducting in-depth interviews with fibromyalgia patients, drawing on cognitive behavior theory to establish the program contents, recruiting experts to test its validity, and conducting a preliminary survey. Methods: To confirm the program's effect, this study used a randomized controlled trial design. The participants were outpatients diagnosed with fibromyalgia in Dong-A University Hospital, Busan. The 30 patients in the experimental group took part in the program, which comprised 8 sessions (90 to 120 minutes) based on cognitive behavior theory, delivered over 8 weeks. Hypothesis testing was carried out using the repeated measures ANOVA. Results: The analysis revealed significant differences between the experimental and control groups in positive automatic thoughts, pain, fatigue, depression, and interpersonal relationships. However, there was no significant difference between the groups in terms of sleep disorders and negative automatic thoughts. Conclusion: This program is a positive effect on physical condition, emotions, and behaviors. It is thus expected to be used to help fibromyalgia patients improve their disease conditions.

Comparison of the effects of articaine and bupivacaine in impacted mandibular third molar tooth surgery: a randomized, controlled trial

  • Tokuc, Berkay;Coskunses, Fatih Mehmet
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.575-582
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    • 2021
  • Background: The aim of this randomized, triple-blind trial was to determine the anesthetic, analgesic, and hemodynamic effects of articaine and bupivacaine in the extraction of impacted mandibular third molar teeth. Methods: Twenty-six patients who underwent removal of bilaterally symmetric mandibular third molars were randomly assigned to articaine and bupivacaine groups in a split-mouth design. The onset of anesthetic action, intraoperative comfort, total amount of solution used, duration of postoperative anesthesia and analgesia, rescue analgesic use, postoperative pain, intraoperative bleeding, and hemodynamic parameters were evaluated. Results: In the articaine group, the onset of anesthetic activity was faster, intraoperative comfort was greater, and effective anesthesia required less local anesthetic solution. The bupivacaine group showed a significantly longer duration of postoperative anesthesia and analgesia, in addition to lower visual analog scale values at 6 and 48 hours postoperatively. There were no significant differences between the two solutions regarding rescue analgesic medication use, intraoperative bleeding, or hemodynamics. Conclusion: Articaine showed greater clinical efficacy than bupivacaine in intraoperative anesthesia, achieving faster onset of anesthetic action and greater patient comfort while also requiring less reinforcement during surgery. However, bupivacaine was superior in terms of postoperative anesthesia, reducing postoperative pain due to its residual anesthetic and analgesic effects. Both anesthetic solutions led to similar hemodynamics at low doses in mandibular third molar surgery

Effect of Lower Trapezius Strengthening Exercise Program on Unstable Support Surface for Neck Pain Patients with Forward Head Posture: A Randomized Controlled Trial

  • Park, Sam-Ho;Lee, Myung-Mo
    • Physical Therapy Rehabilitation Science
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    • v.11 no.2
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    • pp.189-197
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    • 2022
  • Objective: The purpose of this study was to investigate the effect of a lower trapezius strengthening exercise program on an unstable support surface on pain, neck dysfunction, psychosocial factors, and postural alignment in neck pain patients with forward head posture. Design: A randomized controlled trial Methods: A total of 36 neck pain patients participated in this study. Screening tests were performed and assigned to experimental group (n=18) and control group (n=18) using randomization program. Both groups performed the lower trapezius strengthening exercise program. In addition, in the experimental group, an exercise program for lower trapezius muscle strengthening was performed on an unstable support surface. All interventions were performed 3 times a week, for a total of 5 weeks. quadruple visual analogue scale (QVAS), neck disability index (NDI), short form (SF)-12, and postural alignment were measured before and after the intervention to compare their effectiveness. Results: Both groups showed significant differences in QVAS, NDI, SF-12, and postural alignment before and after intervention (p<0.05). In addition, the experimental group showed significant differences in NDI and postural alignment compared to the control group (p<0.05). Conclusions: The lower trapezius strengthening exercise program on unstable support surfaces is an effective intervention method with clinical significance in improving neck disability and postural alignment in patients with neck pain with forward head posture.

Transcutaneous electrical nerve stimulation for pain during propofol injection: a randomized clinical trial

  • Dongwoo, Lee;Juhwa, Jin;Ji Hyo, Kim;Jinyoung, Oh;Younghoon, Jeon
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.6
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    • pp.437-442
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    • 2022
  • Background: Propofol is a short-acting intravenous sedative widely used for procedural sedation and general anesthesia. However, pain during propofol injection is a distressing adverse effect. This study was designed to investigate whether transcutaneous electrical nerve stimulation (TENS) could reduce pain during propofol injection compared to sham TENS. Methods: In a randomized controlled trial, 80 patients were allocated to two groups: the active TENS group received electrical stimulation via two electrodes on the venous cannulation site, whereas the sham TENS group received no stimulus. After 20 min following TENS, propofol 0.5 mg/kg pain was injected intravenously and pain was evaluated using a four-point score (0 = none, 1 = mild, 2 = moderate, 3 = severe). Adverse effects associated with TENS were also recorded. Results: The overall incidence of pain during propofol injection was 47.5% in the TENS group and 87.5% in the sham group (P < 0.001). The incidence of moderate pain was significantly lower in the TENS group (7.5%) than in the sham TENS group (42.5%) (P < 0.001). There were no complications associated with TENS. Conclusion: Pre-treatment with TENS significantly reduced the incidence and intensity of pain during propofol injection.