• Title/Summary/Keyword: randomized clinical trial

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Effects of Healing Beat on autonomic balance, heart rate and anxiety: A randomized controlled trial (Healing Beat 적용이 자율신경균형, 심박동수 및 불안에 미치는 효과: 무작위대조군)

  • Bae, Ik-Lyul
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.12
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    • pp.765-773
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    • 2018
  • The purpose of this study was to investigate the effect of Healing Beat on autonomic balance, heart rate, and anxiety in healthy adults exposed to stressors. Data were collected from 64 healthy volunteers who volunteered after responded to a recruitment announcement at D City University and analyzed using descriptive statistics, the X2-test, the t-test, and repeated measures of ANOVA. Results showed that both experimental and control general characteristics and variables were homogeneous. Significant intergroup differences were obtained for autonomic balance (F = 6.151, p <.001), heart rate (F = 5.455, p <.001), and anxiety (t = -7.633, p <.001). These results indicate Healing Beat is effective at relieving anxiety in stressful situations, and that Healing Beat can be used to relieve stress in many clinical situations or daily life when individuals are exposed to various stressors.

Effects of mechanical intervention on cutaneous sensory change and pressure pain threshold in the same spinal segment of myofascial pain

  • Kim, Do Hyung;Lee, Su-Hyun;Lee, Byoung Hee
    • Physical Therapy Rehabilitation Science
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    • v.8 no.1
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    • pp.15-21
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    • 2019
  • Objective: The purpose of this study was to identify whether cutaneous sensory (CS) changes induced by mechanical intervention (MI) increases the trigger point threshold of the same spinal segment as well as to investigate the relationship between the amounts of change in CS pressure pain thresholds (PPT). Design: Randomized controlled trial. Methods: Thirty-nine persons with myofacial pain (MFP) were recruited in this experiment. The subjects consisted of 20 men and 19 women (age 20-39). MI was applied on the subjects using the Graston technique for 5 minutes to induce CS changes. The CS changes were measured with sensory tests by using the Von Frey Filament, and PPT changes were estimated by using the pressure threshold meter. For the observation of sensory and PPT changes with time, the test was conducted for 15 minutes including a pre, post, and after intervention session. Results: CS threshold increased significantly when MI was applied (p<0.001). On the same spinal segment, changes in the right infraspinatus PPT was observed (p<0.001) but the PPT changes in other muscles were not significantly different. Furthermore, the control group CS and PPT were not significantly different. In addition, regression analysis showed that the CS changes have a larger impact on PPT in the same spinal segment (p<0.001). Conclusions: CS changes induced by MI make to change PPT on the same spinal segment. In other words, it is possible to identify PPT changes following CS changes except for the muscle which belongs to a different spinal segment. Therefore, application of MI is necessary for the CS changes in the same spinal segment. Furthermore, it can be useful in the clinical fields as a method of providing pain control and increasing the PPT.

DentalVibe versus lignocaine hydrochloride 2% gel in pain reduction during inferior alveolar nerve block in children

  • Menni, Alekhya Chowdary;Radhakrishna, Ambati Naga;Prasad, M. Ghanashyam
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.6
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    • pp.397-402
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    • 2020
  • Background: Inferior alveolar nerve block (IANB) is the most common, painful, and anxiety-provoking procedure involving needle insertion for anesthetic solution deposition. DentalVibeⓇ (DV) delivers vibration at a sustained frequency as a counter-stimulation to the site of injection, thereby alleviating pain. The aim of this study was to evaluate and compare the effectiveness of DV and lignocaine hydrochloride 2% gel (Lox 2% jelly) in pain reduction during IANB in children. Methods: A split-mouth randomized clinical trial was designed with a sample of 60 children (age, 6 to 12 years) requiring bilateral IANB for various dental procedures; DV was used while administering IANB and Lox 2% jelly was used as the topical anesthetic before administering IANB at subsequent appointments. During both appointments, pain perception was measured using the sound, eye, motor (SEM) scale and Wong-Baker faces pain rating scale (WBFPRS); oxygen saturation (SpO2) and pulse rate were measured using a pulse oximeter before, during, and after the IANB procedure. The obtained values were tabulated and subjected to statistical analysis. Wilcoxon test was used for intergroup comparison, and Friedman test, for intragroup comparison of measured variables at different treatment phases. Results: The medians and interquartile ranges of the WBFPRS scores recorded during the IANB procedure for DV and Lox 2% jelly were 2 (2-4) and 2 (0-2), respectively (P < 0.05). The SEM scale scores, mean SpO2, and pulse rate did not show any significant differences during the IANB procedure between both treatments. Conclusion: Both DV and Lox 2% jelly were found to be effective in pain reduction during IANB in children.

Cone-beam computed tomographic comparison of chin symphysis bone particles and allograft versus iliac crest bone graft alone for reconstruction of alveolar bone defects in cleft patients

  • Attar, Bijan Movahedian;Soltani, Parisa;Davari, Davood;Mehdizadeh, Mojdeh
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.48 no.2
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    • pp.85-93
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    • 2022
  • Objectives: The aim of this study was to compare morbidities and duration of surgery, as well as bone formation in alveolar defects reconstructed with symphysis bone combined with allograft and iliac crest bone graft in patients with cleft palate. Patients and Methods: This randomized clinical trial was performed with 22 patients with unilateral alveolar cleft with a follow-up period of 12 months. In 12 patients, alveolar defects were reconstructed with chin bone graft plus allograft (Group A), while for the other 10 patients, iliac bone crest was used as donor site (Group B). Duration of surgery as well as occurrence of morbidities and complications were recorded. In addition, cone-beam computed tomographic (CBCT) scans were performed before surgery and 12 months after surgical procedures in order to compare bone formation between the two groups. Results: Postoperative CBCT demonstrated a mean bone fill percentage of 76.9% of the alveolar defect in Group A, compared with 77.0% in Group B. Paresthesia in the lower lip or chin did not occur in any patients of Group A. The mean duration of the surgical process was significantly shorter for Group A (40 minutes vs 76 minutes, P<0.001). In addition, patients in Group A regained normal gait faster than patients in Group B (1 day vs 9.5 days). Conclusion: Mandibular symphysis bone graft in combination with allograft results in favorable outcomes in patients with unilateral alveolar clefts.

Comparative evaluation of the effectiveness of two innovative methods in the management of anxiety in a dental office: a randomized controlled trial

  • Panchal, Jay;Panda, Anup;Trivedi, Krishna;Chari, Deepika;Shah, Rushita;Parmar, Binny
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.4
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    • pp.295-304
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    • 2022
  • Background: The first dental experience is vital in molding a child's attitude towards dentistry and dental outcomes. The cooperation of a child during dental treatment is essential to render successful and high-quality treatment. Dental anxiety is common in children undergoing dental treatment. The success of pediatric dental treatments and patient comfort depends on controlling the levels of patient anxiety in clinical settings. This study aimed to compare the effectiveness of the recorded maternal voice and virtual cognitive tool (Roogies application) in the management of pediatric dental patients. Methods: The study was carried out with children aged of 4-7 years [n = 80, (40 male and 40 female)], without any past dental history, and were randomly allocated into two groups. After informed consent was obtained, the entire procedure was explained to the parents. Anxiety was assessed pre-, during, and post-treatment by measuring pulse rate, and recording Venham Picture Test (VPT) scores. Group A [n = 40; 20 boys and 20 girls)] was provided with a headphone that played a recorded maternal voice. Group B [n = 40; 20 boys and 20 girls)] was administered the virtual cognitive tool. After conditioning the children, oral prophylaxis was performed for both groups. A comparative evaluation was conducted for each treatment session. Results: The intra-group comparison of VPT scores and heart rate for patients assigned to the recorded maternal voice showed a statistically significant difference in dental anxiety (P-value ≤0.001). Conclusion: This study demonstrated that a reduction in dental anxiety with the help of recorded maternal voice forms an important component of non-pharmacological behavior management. Alternatively, the use of a virtual cognitive tool as an anxiety-reducing technique can also be advocated.

The efficacy of low-level diode laser versus laser acupuncture for the treatment of myofascial pain dysfunction syndrome (MPDS)

  • Khalighi, Hamid Reza;Mortazavi, Hamed;Mojahedi, Seyed Masoud;Azari-Marhabi, Saranaz;Parvaie, Parvin;Anbari, Fahimeh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.1
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    • pp.19-27
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    • 2022
  • Background: Myofascial pain dysfunction syndrome (MPDS) is the most common type of temporomandibular disorder. This study compared the efficacies of low-level diode laser therapy (LLLT) and laser acupuncture therapy (LAT) in the treatment of MPDS. Methods: This double-blind randomized controlled clinical trial included 24 patients with MPDS who were randomly divided into two equally sized groups. Patients in the LLLT group received 12 sessions of low-level diode laser irradiation applied to the trigger points of the masticatory muscles during 1 month. The same protocol was also used in the LAT group according to the specific trigger points. We measured pain intensity and maximum mouth opening in both groups at baseline, during treatment, and 2 months after treatment completion. Results: The pain intensities decreased from 6.58±1.31 to 0.33±0.65 and from 7.08 ± 1.37 to 0 in the LLLT and LAT groups, respectively. The maximum mouth openings increased from 32.25 ± 8.78 mm to 42.58 ± 4.75 mm and from 33 ± 6.57 mm to 45.67 ± 3.86 mm in the LLLT and LAT groups, respectively. Pain intensity (P = 0.839) and level of maximum mouth opening (P = 0.790) did not differ significantly between the groups. Conclusion: Our results showed similar efficacy between LLLT and LAT in the treatment of MPDS signs and symptoms.

Effects of the Insulin Therapy Adherence Program for Patients with Type 2 Diabetes: A Randomized Controlled Trial (제2형 당뇨병 환자를 위한 인슐린치료이행증진 프로그램의 효과: 무작위대조군실험설계)

  • Park, Kyung Min;Son, Jung Tae
    • Journal of Korean Clinical Nursing Research
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    • v.28 no.3
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    • pp.277-288
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    • 2022
  • Purpose: This study was conducted to evaluate the effects of the insulin therapy adherence program (INSTA GRAM) for patients with type 2 diabetes mellitus. Methods: This study examined a total of 63 patients with type 2 diabetes for whom the initiation of insulin therapy is being considered or within 6 months of undergoing insulin therapy. INSTAGRAM is a stage-specific intervention consisting of strategies for motivating patients to initiate and maintain insulin therapy using the transtheoretical model on the stages of change, the process of change, and self-efficacy. The participants were randomly assigned to either the INSTAGRAM group (experimental group, n=32) or the standard diabetes education group (control group, n=31). The INSTAGRAM group received 6 sessions over 8 weeks(face-to-face education was conducted in the first and last sessions, and telephone coaching was conducted from the second to fifth sessions). The outcomes were measured by psychological insulin resistance, self-efficacy, and glycosylated hemoglobin (HbA1c). Results: Psychological insulin resistance (p<.001), self-efficacy (p<.001), and HbA1c (p=.024) of the participants in the INSTAGRAM group significantly improved compared to those in the control group. Conclusion: INSTAGRAM is effective in overcoming psychological insulin resistance and improving self-efficacy and HbA1c. Therefore, the INSTAGRAM can be recommended as a nursing intervention for type 2 diabetic patients who delay the initiation of insulin therapy.

Restoration of the Broken Lumbopelvic-hip Neuromuscular Chain and Coordinated Synergistic Activation in Low Back Pain

  • Park, Haeun;Park, Chanhee;You, Joshua (Sung) Hyun
    • Physical Therapy Korea
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    • v.29 no.3
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    • pp.215-224
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    • 2022
  • Background: The presence of the lumbopelvic-hip neuromuscular chain is essential for dynamic spinal stabilization; its therapeutic effects on dynamic movements of the distal extremity segment and underpinning motor mechanism remain unknown and warrant further study on participants with low back pain (LBP). Objects: We aim to compare the effects of the broken chain exercise (BCE) and connected chain exercise (CCE) on electromyography (EMG) amplitude and onset time in participants with and without LBP. Methods: Randomized controlled clinical trial. A convenience sample of 40 nonathletic participants (mean age: 24.78 ± 1.70) with and without LBP participated in this study. All participants underwent CCE for 30 minutes, 30-minute daily. We measured EMG amplitude and onset times on bilateral erector spinae (ES), gluteus maximus (GM), hamstring (HAM), transverse abdominis (TrA), internal oblique (IO), and external oblique (EO) during the prone hip extension (PHE) test before and after the BCE and CCE. We used multivariate analysis of variance (MANOVA) to analyze the amplitude and onset time difference between exercises (BCE and CCE) and Pearson's correlations to determine any synergistic relationship among the HAM, GM, bilateral TrA/IO, and ES muscles. The statistical analyses were used at p < 0.05. Results: MANOVA showed that CCE was more decreased on EMG amplitude in HAM and bilateral ES, while increased GM and contralateral TrA/IO than BCE (p < 0.05). MANOVA EMG onset time data analyses revealed that the main effect of the conditions was significant for all HAM, GM, and bilateral ES muscles, whereas the main effect for the group was significant only for GM and contralateral ES in healthy and LBP groups. Pearson's correlation coefficient was computed to assess the relationship between BCE and CCE on dependent variables. In most of the muscles, there was a strong, positive correlation between the two variables, and there was a significant relationship (p < 0.001). Conclusion: CCE produced more effective and coordinated core stabilization and motor control mechanism in the lumbopelvic-hip muscles in participants with and without LBP during PHE than BCE.

Effects of Bone Marrow Aspirate Concentrate-Platelet-rich Plasma Versus Hyaluronic Acid on Patients with Knee Osteoarthritis: A Randomized Controlled Trial (골수 흡인-혈소판 풍부 혈장과 히알루론산의 관절강내 주사의 효과 비교)

  • Lee, Byung Chan;Kim, Ah Ran;Kim, Eun Kyung;Kim, Sun Jeong;Kim, Sang Jun
    • Clinical Pain
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    • v.19 no.1
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    • pp.8-15
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    • 2020
  • Objective: To compare the therapeutic efficacy of the bone marrow aspirate concentrate (BMAC)- platelet-rich plasma (PRP) complex with hyaluronic acid in patients with knee osteoarthritis. Method: Thirty-four patients with knee osteoarthritis participated in this study. Seventeen patients in the study group underwent BMAC and PRP extraction followed by intra-articular injection of BMAC-PRP complex within affected knee. Seventeen patients in the control group underwent intra-articular injection of hyaluronic acid. Knee injury, osteoarthritic outcome score (KOOS), and EuroQol-5D (EQ-5D) questionnaire were evaluated before, one month, three months, and six months after the injection. Results: There were statistically significant temporal differences in total KOOS scores in both BMAC-PRP and HA groups. However, there were no significant group difference in the study period. In the Sports and Recreational Function Scale, there was statistically significant improvement in the BMAC-PRP group compared to the HA group at three months (p=0.041). There were no side effects or complications in both groups. Conclusion: Intra-articular injection of BMAC-PRP showed better functional recovery in the OA at three months and this can be an alternative treatment in terms of functional recovery in the OA in addition to the decrease of pain.

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

  • Cho, Yeon Wook;Kim, Tae Hee;Lim, Oh Kyung;Lee, Ju Kang;Park, Ki Deok
    • Clinical Pain
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    • v.19 no.1
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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.