Effect of Physical Therapy on Bone Remodelling in Preterm Infants. A Multicenter Randomized Controlled Clinical Trial

Abstract Background: Preterm infants have a low level of bone mineralization compared to those born at term, since 80% of calcium incorporation occurs at the end of pregnancy. The purpose of the present study was to investigate the effect of reflex locomotion therapy on bone modeling and growth in preterm infants and to compare its effect with those of other Physiotherapy modalities.Methods: A multicentre randomized controlled clinical trial was conducted (02/2016 – 07/2020). 106 preterm infants born at the Virgen de la Arrixaca University Clinical Hospital, the General University Hospital of Elche and the Torrecárdenas Hospital in Almería, between 29 and 34 weeks with hemodynamic stability, complete enteral nutrition and without any metabolic, congenital, genetic, neurological or respiratory disorders were evaluated for inclusion. Infants were randomly assigned to three groups: one group received reflex locomotion therapy (EGrlt); another group received passive mobilizations with gentle joint compression (EGpmc); and the control group received massage (CG). All treatments were carried out in the neonatal units lasting one month. The main outcome measure was bone formation and resorption measured with bone biomarkers. A mixed ANOVA was used to compare the results of bone biomarkers, and anthropometric measurements. Results: Infants were randomized to EGrlt (n = 38), EGpmc (n = 32), and CG (n = 36). All groups were similar in terms of gender (p = 0.891 female 47.2%), gestational age (M = 30.753, SD = 1.878, p = 0.39) and birth weight (M = 1413.45, SD = 347.36, p = 0.157). At the end of the study, significant differences were found between the groups in their interaction in bone formation, measured with osteocalcin [F (2,35) = 4.92, p = 0.013, ηp2 = 0.043], in benefit of the EGrlt. Conclusions: Reflex locomotion therapy has been effective in improving bone formation, more so than other Physiotherapy modalities. Therefore, reflex locomotion therapy could be considered one of the most effective physiotherapeutic modalities for the prevention and treatment of osteopenia of prematurity Trial registrstion: Trial retrospectively registered at ClinicalTrials.gov. First posted on 22/04/2020. Registration number: NCT04356807. URL: https://clinicaltrials.gov/ct2/show/NCT04356807?cond=Physical+Therapy+to+Prevent+Osteopenia+in+Preterm+Infants&draw=2&rank=1

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A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

BMC Pregnancy and Childbirth ◽

10.1186/s12884-020-03502-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Leila Seiiedi-Biarag ◽

Mojgan Mirghafourvand ◽

Khalil Esmaeilpour ◽

Shirin Hasanpour

Keyword(s):

Mental Health ◽

Clinical Trial ◽

Premature Infants ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Significant Difference ◽

Postpartum Bonding ◽

Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

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Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

Brazilian Dental Journal ◽

10.1590/s0103-64402012000300009 ◽

2012 ◽

Vol 23 (3) ◽

pp. 235-240 ◽

Cited By ~ 4

Author(s):

Fabricio B. Zanatta ◽

Raquel P. Antoniazzi ◽

Tatiana M. P. Pinto ◽

Cassiano K. Rösing

Keyword(s):

Clinical Trial ◽

Test Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Separate Analysis ◽

Randomized Controlled Clinical Trial ◽

Significance Level ◽

Plaque Removal ◽

Randomized Controlled ◽

Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

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Effectiveness of Water Physical Therapy on Pain, Pressure Pain Sensitivity, and Myofascial Trigger Points in Breast Cancer Survivors: A Randomized, Controlled Clinical Trial

Pain Medicine ◽

10.1111/j.1526-4637.2012.01481.x ◽

2012 ◽

Vol 13 (11) ◽

pp. 1509-1519 ◽

Cited By ~ 34

Author(s):

Irene Cantarero-Villanueva ◽

Carolina Fernández-Lao ◽

César Fernández-de-las-Peñas ◽

Isabel B. López-Barajas ◽

Rosario Del-Moral-Ávila ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Physical Therapy ◽

Pain Sensitivity ◽

Breast Cancer Survivors ◽

Trigger Points ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Myofascial Trigger Points ◽

Randomized Controlled

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A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique

10.1101/2021.12.03.21266946 ◽

2021 ◽

Author(s):

Elisabeth Maria Balint ◽

Beate Grüner ◽

Sophia Haase ◽

Mandakini Kaw-Geppert ◽

Julian Thayer ◽

...

Keyword(s):

Clinical Trial ◽

Interleukin 6 ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Single Center ◽

Paced Breathing ◽

Randomized Controlled ◽

Lr Test ◽

Practice Time

AbstractImportanceVagus nerve stimulation via slow-paced breathing could serve as adjuvant therapeutic approach to reduce excessive inflammation in coronavirus disease 2019 (COVID-19) pneumonia.ObjectiveDoes a slow-paced breathing technique increasing vagal activity reduce Interleukin-6 (IL-6) in patients hospitalized with moderate COVID-19 pneumonia compared to standard care?DesignSingle-center randomized controlled clinical trial with enrolment from February 23rd 2021 through June 17th 2021 and follow-up until July 22nd 2021.SettingWard for infectious diseases and temporary COVID-19 ward, Ulm University Hospital, GermanyParticipantsConsecutive sample of patients hospitalized with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (primary diagnosis). Of 131 patients screened, 48 patients were randomized and 46 patients analyzed (N=23 per group).InterventionsSlow-paced 20-minute breathing exercise three times a day with six breaths per minute (inhale-to-exhale ratio 4:6).Main outcomes and measuresDifferences between intervention and control group in IL-6 calculated using multilevel mixed-effect linear regression models with random slope including the covariates relevant comorbidities, COVID-19 medication, and age.ResultsMean age 57 years±13 years, N= 28 (60%) male, N=30 (65%) with relevant comorbidities. The model including group by time interaction revealed a significantly lower trajectory of IL-6 in the intervention group compared to the control group (effect size Cohens f2=0.11, LR-test p=.040) in the intention-to-treat sample, confirmed by treatment-per-protocol analysis (f2=0.15, LR-test p=.022).Exploratory analysis using the median split of practice time to predict IL-6 of the next morning indicated a dose-response relationship with beneficial effects of practice time above 45 minutes a day.Three patients in each group were admitted at ICU, one died. Oxygen saturation increased during slow-paced breathing (from 95.1%±2.1% to 95.4%±1.6%, p=0.006).Conclusion and relevancePatients practicing slow-paced breathing had significantly lower IL-6 values than controls without relevant side effects. Further trials should evaluate clinical outcomes as well as an earlier start of the intervention, i.e., at symptom onset. This would offer an access to a therapy option not only for high-income, but also for low- and middle-income countries.Trial registrationGerman register of clinical trials (ID: DRKS00023971) https://www.drks.de, Universal Trial Number (UTN) U1111-1263-8658;Key pointsQuestionCan slow-paced breathing reduce Interleukin-6 (IL-6) in hospitalized patients with moderate coronavirus disease 2019 (COVID-19) pneumonia?FindingsSingle-center randomized controlled clinical trial including 46 patients hospitalized with moderate COVID-19 pneumonia. Compared to controls, IL-6 values were significantly lower (small-to-medium effect sizes) in patients who were instructed to practice six breaths per minute for 20 minutes three times a day. More minutes of slow-paced breathing were significantly correlated with lower IL-6 values the next morning.MeaningSlow-paced breathing could be a safe and feasible adjuvant therapeutic approach in moderate COVID-19 pneumonia.

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Randomized Controlled Clinical Trial of Nanostructured Carbonated Hydroxyapatite for Alveolar Bone Repair

Materials ◽

10.3390/ma12223645 ◽

2019 ◽

Vol 12 (22) ◽

pp. 3645 ◽

Cited By ~ 4

Author(s):

Rodrigo F. B. Resende ◽

Suelen C. Sartoretto ◽

Marcelo J. Uzeda ◽

Adriana T. N. N. Alves ◽

José A. Calasans-Maia ◽

...

Keyword(s):

Clinical Trial ◽

Bone Repair ◽

Alveolar Bone ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Double Blind ◽

Socket Preservation ◽

Carbonated Hydroxyapatite ◽

Randomized Controlled

The properties of the biodegradation of bone substitutes in the dental socket after extraction is one of the goals of regenerative medicine. This double-blind, randomized, controlled clinical trial aimed to compare the effects of a new bioabsorbable nanostructured carbonated hydroxyapatite (CHA) with a commercially available bovine xenograft (Bio-Oss®) and clot (control group) in alveolar preservation. Thirty participants who required tooth extraction and implant placement were enrolled in this study. After 90 days, a sample of the grafted area was obtained for histological and histomorphometric evaluation and an implant was installed at the site. All surgical procedures were successfully carried out without complications and none of the patients were excluded. The samples revealed a statistically significant increase of new bone formation (NFB) in the CHA group compared with Bio-Oss® after 90 days from surgery (p < 0.05). However, the clot group presented no differences of NFB compared to CHA and Bio-Oss®. The CHA group presented less amount of reminiscent biomaterial compared to Bio-Oss®. Both biomaterials were considered osteoconductors, easy to handle, biocompatible, and suitable for alveolar filling. Nanostructured carbonated hydroxyapatite spheres promoted a higher biodegradation rate and is a promising biomaterial for alveolar socket preservation before implant treatment.

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Development of Cognitive Abilities through the Abacus in Primary Education Students: A Randomized Controlled Clinical Trial

Education Sciences ◽

10.3390/educsci11020083 ◽

2021 ◽

Vol 11 (2) ◽

pp. 83

Author(s):

Samuel P. León ◽

María del Carmen Carcelén Fraile ◽

Inmaculada García-Martínez

Keyword(s):

Clinical Trial ◽

Cognitive Abilities ◽

Auditory Memory ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

School Students ◽

Beneficial Effects ◽

Randomized Controlled ◽

The Difference

(1) Background: An abacus is an instrument used to perform different arithmetic operations. The objective was to analyze the benefits of mathematical calculations made with an abacus to improve the concentration, attention, memory, perceptive attitudes, and creativity cognitive abilities of primary school students. (2) Methods: A total of 65 children, aged 7–11 years (8.49 ± 1.65) participated in this randomized controlled clinical trial. The children were randomly distributed into a control group (n = 34) and experimental group (n = 31). The questionnaires used were the D2 test to measure attention and concentration, the Difference Perception Test (FACE-R) test for the perception of differences, the test of immediate auditory memory (AIM), and the test to evaluate creative intelligence (CREA). (3) Results: No significant differences were found between both groups before the intervention. Significant improvements were observed in the cognitive parameters of concentration, memory, perceptive attitudes, and creativity after the intervention, using the abacus, with respect to the control group. (4) Conclusions: It is demonstrated that a calculation program based on the use of the abacus for 8 weeks has beneficial effects on the cognitive capacities of concentration, immediate auditory memory, perceptive attitudes, and creativity. In addition, the benefits of using the abacus to improve cognitive attitudes are reported.

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Adhesion prevention after endometriosis surgery — results of a randomized, controlled clinical trial with second-look laparoscopy

Langenbeck s Archives of Surgery ◽

10.1007/s00423-021-02193-x ◽

2021 ◽

Author(s):

Bernhard Krämer ◽

Jürgen Andress ◽

Felix Neis ◽

Sascha Hoffmann ◽

Sara Brucker ◽

...

Keyword(s):

Clinical Trial ◽

Saline Solution ◽

Adhesion Formation ◽

Adhesion Prevention ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Adhesion Barrier ◽

Randomized Controlled ◽

Endometriosis Surgery

Abstract Purpose Adhesion formation after endometriosis surgery is a severe problem affecting up to 90% of patients. Possible complications include chronic pain, ileus, and secondary infertility. Therefore, effective adhesion prophylaxis is desirable, for which the adhesion barrier 4DryField® PH is evaluated in the present clinical study. It is a starch-based powder that forms a gel after irrigation with saline solution and thus separates surgical sites as physical barrier for adhesion prevention. Methods Fifty patients with extensive and deep infiltrating endometriosis were included in this prospective, randomized, controlled clinical trial with two-staged laparoscopic approach. The patients were randomized into two groups, one receiving 4DryField® PH and the other irrigation with saline solution for adhesion prevention. Adhesion formation was directly scored during second-look interventions considering incidence, extent, and severity. Adhesion prevention treatment in the second surgery was performed corresponding to the first intervention to evaluate the long-term outcome in the later course. Results Both groups were comparable with respect to relevant patient parameters. Severity and extent of adhesions were significantly reduced by 85% in the 4DryField® PH group compared to the control group (mean total adhesion score 2.2 vs. 14.2; p = 0.004). Incidence of adhesion formation based on the number of affected sites was significantly reduced by 53% in the intervention vs. control group (mean 1.1 vs. 2.3 sites; p = 0.004). Follow-up of secondary endpoints is not yet completed; results will become available at a later stage. Conclusion Adhesion formation could be reduced significantly by 85% by application of the adhesion barrier 4DryField® PH. Trial registration Trial registration main ID: DRKS00014720, secondary ID: U1111-1213-4142; date of registration 09th May 2018.

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Smartphone application for celiac patients: assessing its effect on gastrointestinal symptoms in a randomized controlled clinical trial

10.21203/rs.3.rs-33137/v1 ◽

2020 ◽

Author(s):

Zeinab Nikniaz ◽

Masood Shirmohammadi ◽

Elham Masserat ◽

Zahra Akbari Namvar

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

Gastrointestinal Symptoms ◽

Smartphone Application ◽

Control Group ◽

Controlled Clinical Trial ◽

Trial Registry ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

The Mean

Abstract Background: We aimed to study the effectiveness of a “celiac” smartphone application on gastrointestinal symptoms in celiac patients. Methods: In the present randomized controlled clinical trial, 60 celiac patients were randomly assigned to receive education through a smartphone application (n=30) or conventional clinical education (n=30). We assessed the gastrointestinal symptoms using the gastrointestinal symptom rating scale (GSRS) questionnaire at baseline and three months after interventions. The GSRS total score, celiac disease GSRS (CD-GSRS) score, abdominal pain, reflux, diarrhea, constipation, and indigestion scores were calculated. Results: Out of 60 randomized patients, 58 patients completed the study. In comparison to baseline, the mean score of GSRS total score (p=0.04), CD-GSRS score (p=0.001), and indigestion subscore (p<0.001) were significantly decreased in the intervention group. In the control group, compared to baseline, the mean scores of CD-GSRS score (p=0.03) and abdominal pain subscore (p=0.04) were significantly reduced; and the mean score of reflux (p=0.01) subscore was significantly increased. The results of the between-group comparisons showed that although the mean GSRS and CD-GSRS total scores were lower in the intervention group compared with the control group, the differences were not statistically significant. In terms of GSRS subscores, there was a significant difference between the two groups only in the mean score of indigestion (P=0.01).Conclusion: According to the results, smartphone application had a significantly positive effect on indigestion symptoms compared with routine clinic education. However, more large studies with longer duration of the follow-up period are needed to assure this approach Trial registration: The protocol of the study was registered in the Iranian registry of clinical trials (IRCT code: IRCT20170117032004N2). trial registry webpage: : https://www.irct.ir/user/trial/40187/view. Trial registry date: 2019.6.26

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