Registro Brasileiro De Ensaios Clínicos Research Articles

Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial

BackgroundMinimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) are two low-cost MIGS procedures that communicate the anterior chamber to Schlemm’s canal. Most of the available publications on MIGS are either case series or retrospective studies, with different study protocols. The aim of this manuscript is to describe a randomized clinical trial (RCT) protocol to compare the long-term intraocular pressure (IOP) control and the safety of both procedures in eyes with primary open-angle glaucoma.MethodsThis is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days.DiscussionOur study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients’ quality of life.Trial registrationRetrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y. Registered on July 29, 2023.The study was approved by the Ethics Committee of the University of Campinas, Brazil.

Feasibility and effectiveness of a remote individual rehabilitation program for people with Parkinson's disease living in the Brazilian Amazon: a randomized clinical trial.

Parkinson's disease (PD) is a chronic and progressive neurodegenerative disorder, and the current treatment involves pharmacological intervention and physiotherapy. Telerehabilitation, which involves remote support and guidance for patients undergoing rehabilitation, can potentially improve access to physiotherapy services for people with Parkinson's disease, especially those who face geographic barriers to healthcare. The primary aim of this study was to assess the feasibility and efficacy of a telerehabilitation program for people with Parkinson's disease living in an underrepresented community of the Brazilian Amazon. We conducted a parallel-group, single-center, single-blind, phase 2 randomized controlled clinical trial involving 19 participants diagnosed with Parkinson's disease from Belém, Brazil. Participants were assigned to a 4-week individual telerehabilitation program or a booklet-based exercise program (control group). Assessments were conducted before the intervention, immediately after the intervention, and 4 weeks after the end of the intervention. We showed that our telerehabilitation program had high adherence among patients, with minimal adverse effects. Both telerehabilitation and booklet orientation reduced the time to complete the Timed Up and Go test. In conclusion, our telerehabilitation program was feasible and effective for people with Parkinson's disease in an Amazonian setting. This trial was registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) under the identifier: RBR-6sz837s.

One year follow-up on a randomized study investigating serratus anterior muscle and pectoral nerves type I block to reduced neuropathic pain descriptors after mastectomy

Breast cancer is the second most common diagnosed type of cancer in women. Chronic neuropathic pain after mastectomy occurs frequently and is a serious health problem. In our previous single-center, prospective, randomized controlled clinical study, we demonstrated that the combination of serratus anterior plane block (SAM) and pectoral nerve block type I (PECS I) with general anesthesia reduced acute postoperative pain. The present report describes a prospective follow-up study of this published study to investigate the development of chronic neuropathic pain 12 months after mastectomy by comparing the use of general anesthesia alone and general anesthesia with SAM + PECS I. Additionally, the use of analgesic medication, quality of life, depressive symptoms, and possible correlations between plasma levels of interleukin (IL)-1 beta, IL-6, and IL-10 collected before and 24 h after surgery as predictors of pain and depression were evaluated. The results showed that the use of SAM + PECS I with general anesthesia reduced numbness, hypoesthesia to touch, the incidence of patients with chronic pain in other body regions and depressive symptoms, however, did not significantly reduce the incidence of chronic neuropathic pain after mastectomy. Additionally, there was no difference in the consumption of analgesic medication and quality of life. Furthermore, no correlation was observed between IL-1 beta, IL-6, and IL-10 levels and pain and depression. The combination of general anesthesia with SAM + PECS I reduced the occurrence of specific neuropathic pain descriptors and depressive symptoms. These results could promote the use of SAM + PECS I blocks for the prevention of specific neuropathic pain symptoms after mastectomy.Registration of clinical trial: The Research Ethics Board of the Hospital Sirio-Libanes/Brazil approved the study (CAAE 48721715.0.0000.5461). This study is registered at Registro Brasileiro de Ensaios Clinicos (ReBEC), and ClinicalTrials.gov, Identifier: NCT02647385.

The use of 3D ceramic block graft compared with autogenous block graft for rehabilitation of the atrophic maxilla: a randomized controlled clinical trial

BackgroundDental implant placement may require a bone graft for vertical and horizontal alveolar ridge augmentation. Due to its osteoconduction, osteoinductive, and osteogenesis, autogenous bone graft characteristics are considered the standard gold treatment. However, autografts can promote postoperative morbidity and implicate difficulties concerning the graft adaptation to the recipient's bone since it can eventually avoid gaps. To overcome these issues, this trial will compare the performance of Plenum® Oss 3Dβ fit, an alloplastic graft, and a 3D-printed patient-specific graft based on β-tricalcium phosphate to the autograft procedure.MethodsThis is a split-mouth randomized clinical study designed to evaluate the performance of personalized (patient-specific) bioceramic bone grafts (Plenum® Oss 3Dβ fit) for bone augmentation of the atrophic anterior maxilla in comparison to the autogenous bone graft. We hypothesize that the gain and maintenance of the grafted area volume and the quality of the newly formed bone tissue after eight months postoperative with the synthetic patient-specific graft will be superior to the autogenous bone graft. To assess the quantity and the quality of bone neoformation, volumetric and histological analyses will be performed.DiscussionThe fabrication of medical devices by additive manufacturing presents advantages over conventional manufacturing processes, mostly related to the precision of geometry and anatomy. Additionally, the osteoconductive proprieties of β-tricalcium phosphate enable this synthetic bone substitute as an alternative solution over autogenous graft for bone defect reconstruction. Thus, patient-specific bone grafts can potentially improve patient satisfaction, reducing the need for autogenous bone grafts, consequently avoiding implications related to this type of treatment, such as patient morbidity.Trial registrationThis study is registered in REBEC (Registro Brasileiro de Ensaios Clínicos): RBR-76wmm3q; UTN: U1111-1272-7773. Registration date: 14 September 2021.

A randomized clinical trial to evaluate the effects of icodextrin on left ventricular mass index in peritoneal dialysis

Left ventricular hypertrophy is a risk factor for cardiovascular mortality in patients on peritoneal dialysis (PD). Because icodextrin has a greater ultrafiltration power compared with glucose-based solutions for long dwell, it could improve left ventricular mass by reducing fluid overload. This was a randomized clinical trial that included patients on PD recruited from 2 teaching hospitals, in Sao Paulo—Brazil. Patients were allocated to the control glucose group (GLU) or the intervention icodextrin (ICO) group. Clinical and cardiac magnetic resonance image (MRI) parameters were evaluated at baseline and 6 months after randomization. The primary outcome was the change in left ventricular mass adjusted by surface area (ΔLVMI), measured by cardiac MRI. A total of 22 patients completed the study (GLU, N = 12 and ICO, N = 10). Baseline characteristics such as age, sex, underlying disease, and time on dialysis were similar in both groups. At baseline, 17 patients (77.3%) presented with left ventricular hypertrophy with no difference between groups (p = 0.748). According to the total body water (TBW)/extracellular water (ECW) ratio, 36.8% and 80% of patients from GLU and ICO groups, respectively, were considered hypervolemic (p = 0.044). During follow-up, ΔLVMI was 3.9 g/m (− 10.7, 2.2) in GLU and 5.2 (− 26.8, 16.8) in ICO group (p = 0.651). ΔLVMI correlated with change in brain natriuretic peptide (r = 0.566, p = 0.044), which remained significant in a multiple regression analysis. The use of the icodextrin-based solution in prevalent patients on PD compared with a glucose-based solution was not able to improve LMV. A larger randomized trial with a longer follow-up period may be needed to show changes in LVM in this patient population.Trial registration: this study has been registered at ReBEC (Registro Brasileiro de Ensaios Clinicos) under the identification #RBR-2mzhmj2, available at: https://ensaiosclinicos.gov.br/pesquisador.

GAUCHO - Trial Genicular Artery Embolization Using Imipenem/Cilastatin vs. Microsphere for Knee Osteoarthritis: A Randomized Controlled Trial

Genicular artery embolization (GAE) has emerged as a treatment option to improve quality of life in patients suffering from moderate-to-severe pain refractory to conservative treatment of knee osteoarthritis, with encouraging results. This paper describes the study protocol of a single-center, double-blind, randomized controlled trial designed to evaluate and compare the safety and efficacy of GAE using imipenem/cilastatin vs. microspheres for the treatment of moderate-to-severe pain associated with knee osteoarthritis. We hypothesized that there will be no difference in safety and efficacy outcomes. The study received ethics approval of the institutional review board with number 4.364.391 / CAAE: 37590820.3.0000.5342 and is registered onto the Registro Brasileiro de Ensaios Clinicos (ReBEC), with number RBR-2h5rwgb. Technical success was defined as embolization of at least 1 feeding artery supplying the hyperemic synovium of the knee joint. Primary outcome: clinical success was defined as improvement in symptoms, 50% reduction in Western Ontario and McMaster Universities Osteoarthritis Index pain scores or an increase of at least 10 points in the Knee Injury and Osteoarthritis Outcome Score from baseline to 3months of follow-up. Secondary outcome: radiological success was defined as significant improvement in the Whole-Organ Magnetic Resonance Imaging Score for knee synovitis considering the embolized areas at 12months of follow-up after GAE and a reduction in the analgesia or other conservative therapies for knee pain used by the patient at 3 and 12months of follow-up. Clinical assessments will be performed before GAE, during GAE and at hospital discharge (for Visual Analog Scale of pain), and at 30days, 3months, and 12months after GAE.

Predicting latent classes of drug-related problems among adolescents: secondary analysis of a cluster randomized controlled trial.

Objective:To detect latent patterns of drug-related problems and their predictors among adolescents.Methods:A three-wave randomized controlled trial was conducted among 6,391 7th and 8th graders (51.02% girls) at 72 public schools in six Brazilian cities to evaluate the #Tamojunto school-based drug prevention program. Patterns of drug use and behavior problems were identified through latent class analysis, and logistic regression analyses were used to detect predictors of high-risk and low-risk groups.Results:Two groups were found that best explained the patterns of drug use and problem behaviors: high drug use/high problems and low drug use/low problems, representing 36.7 and 63.3% of the sample, respectively. No program effect was a determinant of the risk of belonging to these groups. Any reported problem behavior in the year preceding baseline assessment increased the likelihood of belonging to the high-risk group at the 21-month follow-up by 16 times. Alcohol use at baseline and female gender increased the likelihood of belonging to the high-risk group by 70%.Conclusion:Previous behavior problems and alcohol use were the strongest predictors of higher risk, suggesting that effective earlier interventions and early screening for alcohol use and behavioral problems are needed at schools, particularly for girls.Clinical trial registration:Registro Brasileiro de Ensaios Clínicos (REBEC), RBR-4mnv5g

Association between Symptoms of Psychological Distress in Brazilian Elderly and Socio-Demographic Factors During the COVID-19 Pandemic

Background: The context of the worldwide pandemic of COVID-19 revealed the vulnerability of elderly people and the psychological consequences of this. This paper under analysis from the Life Span perspective, analyses the developmental trajectory in relation to genetic-biological and socio-cultural influences of elderly people. Methods: The research has an exploratory nature and was conducted with a sample of 289 Brazilian elderly aged over 60 years, recruited from the snowball technique, by virtual means. Findings: The results indicated the majority of participants were female, with schooling ranging from 13 to 18 years old, of Christian-Catholic religion, cohabitated with adult members, had a family income greater than US$ 229.66 and were retired. The most frequent symptoms of psychological discomfort were restlessness, insomnia, muscle tension, and the desire to cry in males, and were most frequent in family income was between US$ 172.25 and US$ 229.66 and had a housing size less than 50 m². Interpretation: It was concluded that there was a significant association between socio-demographic and psychological factors, indicating variability between genders, family income and housing situation regarding the course of psychological distress in older adults. This demonstrates relevant factors for the identification of problems related to mental health and living conditions in the elderly population. Clinical Trial Registration Details: The study was registered on the Registro Brasileiro de Ensaios Clinicos (ReBec) platform under code RBR-9pgwfc - Psychological effects of social isolation in the coronavirus pandemic; UTN: U1111-1250-1962 (04/09/2020). Funding Information: The data collection for this research was funded by Mineracao Paragominas S/A (Hydro). Declaration of Interests: None to declare. Ethics Approval Statement: The project was submitted to and approved by the Research Ethics Committee, Opinion no. 3.954.129, CAAE: 30365720.8.0000.0008.).

Sleep quality and chronic pain in community dwelling older adults: preliminary results

Background: The natural process of human aging causes biopsychosocial alterations, which can trigger chronic pain and poor sleep quality in older adults. Considering the high prevalence and possible association between these two clinical conditions, special attention from public health policies is necessary to provide quality aging. Objective: To verify if there is an association between chronic pain and sleep quality among older adults in the community. Methods: A quantitative, cross-sectional study on the association of chronic pain with the sleep quality among older people in the community. Participants were evaluated using the Pittsburgh Sleep Quality Index (PSQI); Visual Analog Pain scale; questionnaires of sociodemographic and clinical data, assessment of cognitive impairment through the Mini Mental State Examination, and anthropometric assessments. The data were submitted to descriptive statistics. The means between the groups of older people with and without chronic pain were compared using the Student's t test for independent samples and Pearson's correlation coefficient (r) was used to analyze the association of PSQI with pain intensity. Results: In total, 51 older women were included, with a mean age of 70 ± 8 years. The majority had a low level of education (52.9%), low financial income (64.7%), and chronic pain (56.9%). It was found that the older adults with chronic pain presented worse sleep quality when compared those without chronic pain and a moderate (r=0.595) and significant (p<0.01) correlation between sleep quality and the intensity of chronic pain was observed. Conclusion: Older adults in the community with chronic pain present worse sleep quality when compared to the older adults without pain. There is a strong correlation between the intensity of chronic pain and sleep quality in older adults; the greater the intensity of pain, the worse the sleep quality. Trial Registration: Registro Brasileiro de Ensaios Clínicos (REBEC) Identifier: RBR-3cqzfy

Do bulk-fill resins decrease the restorative time in posterior teeth? A systematic review and meta-analysis of in vitro studies.

The aim of the present study was to compare the restorative time for filling cavities in posterior teeth using bulk-fill and conventional resin composites through a systematic review and meta-analysis. A search for clinical trials and laboratory studies was performed in PubMed/MEDLINE, Scopus, the Latin American and Caribbean Health Sciences Literature database, the Brazilian Library in Dentistry, Cochrane Library, Clinical Trials, and ReBEC (Registro Brasileiro de Ensaios Clínicos) databases without publication year or language restriction. Two reviewers identified eligible studies according to the inclusion criteria: bulk-fill compared to conventional resin in class I or II, and the restorative time as an outcome. A meta-analysis of the restorative time mean difference between composites was performed (inverse variance method, random effects model; Z-test, P≤.05). From the 662 eligible studies, 133 were selected for full-text analysis; three were included in the systematic review and in the meta-analysis. Overall, the restorative time was lower when bulk-fill was used (P=.0007, Z=3.37), as the subgroup full-body bulk-fill (P<.00001, Z=21.00). There was no difference in restorative time between flowable bulk-fill and conventional resins (P=.08, Z=1.76). Moderate-to-substantial heterogeneity was detected. Full-body bulk-fill composites decrease the restorative time in posterior teeth compared to conventional resins. Full-body bulk-fill resins require a shorter restorative time to perform restorations in posterior teeth than conventional resins, but the same is not valid for flowable bulk-fill resin composites.

Pilot study of a two-arm non-randomized controlled cluster trial of a psychosocial intervention to improve late life depression in socioeconomically deprived areas of S\xe3o Paulo, Brazil (PROACTIVE): feasibility study of a psychosocial intervention for late life depression in S\xe3o Paulo

BackgroundDepression is a common and recurrent condition among older adults and is associated with poor quality of life and increased health care utilization and costs. The purpose of this pilot study was to assess the feasibility of delivering a psychosocial intervention targeting depression, and to develop the procedures to conduct a cluster randomized controlled trial among older adults registered with primary care clinics in poor neighbourhoods of São Paulo, Brazil.MethodsWe conducted a pilot study of a two-arm cluster, non-randomized controlled trial. Two primary care clinics adhering to the Family Health Strategy were allocated to either the intervention or the control arm. In the control arm, patients received enhanced usual care consisting of staff training for improved recognition and management of depression. In the intervention arm, alongside the enhanced usual care, patients received a 17-week psychosocial intervention delivered by health workers assisted with an application installed in a tablet.ResultsWe randomly selected 579 of 2020 older adults registered in the intervention clinic to participate in the study. Among these individuals, 353 were assessed for depression and 40 (11.0%) scored at least 10 on the PHQ-9 and were therefore invited to participate. The consent rate was 33/40 (82%) with a resulting yield of 33/579 (5.7%). In the control arm, we randomly selected 320 older adults among 1482 registered in the clinic, 223 were assessed for depression and 28 (12.6%) scored 10 or above on the PHQ-9. The consent rate was 25/28 (89%), with a resulting yield of 25/320 (7.8%). Of the 33 who consented in the intervention arm, 19 (59.4%) completed all sessions. The mean PHQ-9 at follow-up (approximately 30 weeks after inclusion) were 12.3 (SD = 3.7) and 3.8 (SD = 3.9) in the control and intervention arms, respectively. Follow-up rates were 92 and 94% in control and intervention arms, respectively.ConclusionsIdentification and engagement of clinics, randomization, recruitment of individuals, measures, and baseline and follow-up assessments all proved to be feasible in primary care clinics in São Paulo, Brazil. Results support the development of a definitive cluster randomized controlled trial.Trial registrationThis study was retrospectively registered with Registro Brasileiro de Ensaios Clínicos (ReBEC), number RBR-5nf6wd. Registered 06 August 2018.

Vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior mesh versus abdominal sacrocervicopexy for the treatment of primary apical prolapse in postmenopausal women: a randomized controlled study.

We compared vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior polyvinylidene fluoride mesh versus abdominal sacrocolpopexy for the treatment of primary apical prolapse in postmenopausal women. A prospective, randomized, single-blind, parallel study [Registro Brasileiro de Ensaios Clinicos (REBEC) trial register code RBR-7t6rg2] was performed from October 2015 to May 2016. A total of 71 postmenopausal women with advanced pelvic organ prolapse (POP) and undergoing surgery were randomized to the abdominal sacrocolpopexy (ASC) (n= 36) or the vaginal sacrospinous fixation with anterior mesh (VSF-AM) (n= 35) groups. Pelvic Organ Prolapse Quantification (POP-Q) system classification was performed for objective assessment, and the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaires were filled out for subjective evaluation by women before and 1year after surgery. All procedures were performed by a single surgeon. Both groups had improvement in almost POP-Q points (except for vaginal length in the VSF-AM group) and all ICIQ scores. The ASC group had a longer operative time (129 versus 117min, p= 0.0038) and duration for return to activities (103 versus 57days, p< .05). Four women (11%) in the VSF-AM group were reoperated versus none from the ASC group (p =.05). Although the study did not achieve the planned recruitment, after 12months of follow-up, ASC did not differ from VSF-AM in objective and subjective scores (ICIQ questionnaires; POP-Q measurements). Recovery time was longer after open abdominal surgery.

Effect of diacerein on renal function and inflammatory cytokines in participants with type 2 diabetes mellitus and chronic kidney disease: A randomized controlled trial.

Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM), but for participants with chronic kidney disease (CKD) its effect is unknown. This study aimed to evaluate the effect of diacerein vs. placebo on urinary albumin/creatinine ratio (ACR), glomerular filtration rate (GFR), and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP) and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with diacerein enrolled seventy-two participants with CKD, aged 30–80 years, with glycated hemoglobin levels from 53–97 mmol/mol (7.0–11.0%), receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05), there were no changes in the IL levels at the 75th percentile.Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04), improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure.Trial registration: Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC) U1111-1156-0255

Efeito do método Pilates na flexibilidade, qualidade de vida e nível de dor em idosos

Objetivo: Avaliar a influência do método Pilates na flexibilidade, nível de dor e qualidade de vida em idosos. Métodos: Participaram do estudo 31 idosas (65,84±3,64 anos) que foram dividas em dois grupos: grupo controle (n=17) e grupo Pilates (n=14). O Grupo Pilates realizou treinamento com o método Pilates, enquanto o controle recebeu palestras. A avaliação foi composta por testes específicos de dor (Escala Visual Analógica), flexibilidade (Sentar e Alcançar, Ângulo Poplíteo) e qualidade de vida (SF-36), ao término das oito semanas foi realizada a reavaliação. Resultados: O Grupo Pilates apresentou melhora da flexibilidade no teste Sentar e Alcançar (p=0,033), Ângulo Poplíteo direito (p=0,015) e esquerdo (p=0,0027), diminuição do nível de dor (p=0,0187) e manutenção da qualidade de vida. O grupo controle não apresentou diferença significativa. Conclusão: O método Pilates pode contribuir na redução da dor, aumento da flexibilidade e manutenção da qualidade de vida em idosas.&#x0D; Registro Brasileiro de Ensaios Clínicos: RBR-9mndx8