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1.
Medicine (Baltimore) ; 99(40): e22589, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019477

RESUMO

BACKGROUND: Trigeminal neuralgia (TN) is a disease accompanied by severe facial pain, which seriously affects the daily life of patients. Acupuncture is widely used by Traditional Chinese Medicine doctors to treat various painful diseases. Acupuncture combined with the treatment of trigeminal neuralgia can increase the analgesic effect and reduce side effects. However, there is still a lack of more quality multi-center clinical controlled trials and comprehensive meta-analysis, and a lack of more comprehensive and stronger evidence-based medical evidence. METHODS: The 2 reviewers used the same search strategy to search CNKI, PubMed, Web of Science, Cochrane Library, Scopus, EBSCO, and the search date is until July 19, 2020. Two people read the retrieved literatures independently, and then delete duplications. Then, use the "risk of bias" tool in Cochrane Handbook 5.2 to score. Only documents with a score greater than 5 can be included. Make a table of literature characteristics, extract baseline patient data, research methods and possible risks of bias in the literature, interventions in treatment and control groups, outcome evaluation indicators (BNI, VAS, ER and AE), and research funding support. Use Review Manager 5.3.5 for meta-analysis, use Stata 15 for regression analysis to find the source of heterogeneity, and then perform subgroup analysis to resolve the heterogeneity based on the corresponding source. RESULTS: The analysis of BNI, VAS, ER and AE data can provide high-quality evidence for high-quality synthesis and/or descriptive analysis of the effectiveness and safety of acupuncture treatment of various causes of urinary retention. CONCLUSION: This study can provide more comprehensive and strong evidence to prove whether acupuncture is effective and safe in the treatment of TN patients. REGISTRATION: The research has been registered and approved on the PROSPERO website. The registration number is CRD42019119606.


Assuntos
Terapia por Acupuntura/métodos , Medicina Tradicional Chinesa/métodos , Neuralgia do Trigêmeo/terapia , Terapia por Acupuntura/efeitos adversos , Estudos de Avaliação como Assunto , Dor Facial/etiologia , Dor Facial/terapia , Feminino , Humanos , Masculino , Medicina Tradicional Chinesa/efeitos adversos , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Segurança , Resultado do Tratamento , Neuralgia do Trigêmeo/patologia , Retenção Urinária/etiologia , Escala Visual Analógica
2.
Medicine (Baltimore) ; 99(40): e22598, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019480

RESUMO

BACKGROUND: Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH. METHODS: Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling ("positive" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations. OBJECTIVES: To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH. TRIAL REGISTRATION NUMBER: ChiCTR1900020888; Pre-results.


Assuntos
Tratamento por Ondas de Choque Extracorpóreas/métodos , Necrose da Cabeça do Fêmur/terapia , Cabeça do Fêmur/patologia , Infusões Intraósseas/instrumentação , Adulto , Artroplastia Subcondral/efeitos adversos , Artroplastia Subcondral/métodos , Doenças da Medula Óssea/patologia , Protocolos Clínicos , Terapia Combinada/métodos , Diagnóstico Precoce , Edema/induzido quimicamente , Feminino , Cabeça do Fêmur/efeitos dos fármacos , Necrose da Cabeça do Fêmur/classificação , Seguimentos , Humanos , Infusões Intraósseas/métodos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Segurança , Resultado do Tratamento , Escala Visual Analógica
3.
Rev. int. androl. (Internet) ; 18(3): 101-106, jul.-sept. 2020. ilus, tab, graf
Artigo em Espanhol | IBECS | ID: ibc-193601

RESUMO

OBJETIVO: Desarrollar un instrumento visual analógico para diagnosticar a los pacientes con disfunción eréctil, establecer la capacidad de comprensión del mismo en la población y compararlo con la escala «gold standard» en la enfermedad, sentando las bases para su futura validación. MATERIAL Y MÉTODOS: Estudio transversal que incluyó a todos los hombres mayores de 18 años del Servicio de Urología del Hospital Juárez de México cuyo motivo de consulta fue la disfunción eréctil. Los pacientes fueron evaluados utilizando dos herramientas clínicas: el Índice Internacional de Función Eréctil y la Escala Visual Analógica de Función Eréctil Pineda consecutivamente. Las características sociodemográficas de los pacientes incluyeron edad, idioma, nivel educativo, localidad y estado civil. Se valoró la comprensión, el tiempo de respuesta y el grado de disfunción. Las variables cualitativas se analizaron con Chi cuadrado de Pearson χ2 y las cuantitativas con la prueba «U» de Mann-Whitney. RESULTADOS: El registro final incluyó a 227 pacientes, encontrando una edad promedio de 55,6±14 años. La mayoría de la población (94,7%) se comunicaba mediante el idioma español. Existen diferencias estadísticamente significativas entre ambas escalas, en la comprensión, el grado de disfunción, el puntaje final y el tiempo de respuesta, todas con una p de 0,0001. Los pacientes con menor nivel educativo fueron capaces de responder completa y más prontamente el cuestionario Escala Visual Analógica de Función Eréctil Pineda que el Índice Internacional de Función Eréctil, no obstante no podemos asumir absolutamente que lo comprendan mejor. CONCLUSIONES: La Escala Visual Analógica de Función Eréctil Pineda es un prototipo de escala visual que puede utilizarse como alternativa al cuestionario Índice Internacional de Función Eréctil, especialmente en pacientes que presenten limitaciones académicas y lingüísticas


OBJECTIVE: To develop an analog visual instrument to diagnose patients with erectile dysfunction, to establish the ability to understand it in the population and to compare it with the "gold standard" scale for the disease, providing a basis for its future validation. MATERIAL AND METHODS: Cross-sectional study that included all 18 years old men and older, of the urology service of Juarez Hospital of Mexico City, whose reason for consultation was erectile dysfunction. The patients were assessed using two clinical tools: the International Index of Erectile Function and the Erectile Function Pineda Visual Analog Scale consecutively. The sociodemographic features of the patients included age, language, educational level, location and marital status. The comprehension, the response time and the degree of dysfunction were assessed. The qualitative variables were analyzed with Pearson's chi square and the quantitative variables with the Mann-Whitney U test. RESULTS: The final registry included 227 patients, finding an average age of 55.6±14 years. The majority of the population (94.7%) communicated through the Spanish language. There are statistically significant differences between both scales, in the understanding, the degree of dysfunction, the final score and the response time, all with a p=,0001. The patients with lower educational level were able to respond completely and more quickly the Erectile Function Pineda Visual Analog Scale questionnaire than the International Index of Erectile Function. However, we cannot assume that they understand it better. CONCLUSIONS: The Erectile Function Pineda Visual Analog Scale is a prototype of a visual scale that can be used as an alternative to the International Index of Erectile Function questionnaire, especially in patients with academic and linguistic limitations


Assuntos
Humanos , Masculino , Adolescente , Pessoa de Meia-Idade , Disfunção Erétil/diagnóstico , Escala Visual Analógica , Estudos Transversais , Classificações em Saúde , Técnicas e Procedimentos Diagnósticos/instrumentação , Fatores Socioeconômicos , México
4.
Medicine (Baltimore) ; 99(35): e21925, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871930

RESUMO

BACKGROUND: Chronic pelvic inflammatory disease (CPID) is a difficult-to-treat gynaecological disorder, which has complex etiologies, among married women. In recent years, moxibustion has gradually shown its clinical advantages and been more and more widely used In China. The protocol is try to synthesize and assess the effectiveness and safety of moxibustion for patients with CPID. METHODS: Seven databases as following: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, WangFang Database, Chinese Scientific Journal Database, Chinese Biomedical Literatures Database will be searched from their inception to May 2020. No restrictions about language and status. Study selection, data collection, and quality assessment will be respectively conducted by 2 researchers. Based on the heterogeneity test results, the fixed-effects or random-effects model will be selected to synthesize data. The effective rate, Pelvic inflammatory mass diameter and Pelvic fluid depth will be the primary outcomes. Patient reported outcome scale, visual analog scale, C-reactive protein, transforming growth factor ß1 =  transforming growth factor ß, incidence of any adverse events will be the secondary outcomes. Revman 5.4 software will be implemented for data synthesis. Dichotomous data will be represented by risk ratio for efficacy and safety of CPID treated with moxibustion, while continuous data will be represented by mean difference with a 95% confidence interval. RESULTS: The results of this study will be published in a peer-reviewed journal. This study will provide a comprehensive review of the available evidence for the treatment of moxibustion with CPID. CONCLUSIONS: This study expects to provide high-quality, evidence-based recommendations on further treatment for clinical guidance of CPID. TRIAL REGISTRATION NUMBER: CRD42020158744 in PROSPERO 2020.


Assuntos
Metanálise como Assunto , Moxibustão , Doença Inflamatória Pélvica/terapia , Revisões Sistemáticas como Assunto , Proteína C-Reativa/análise , Feminino , Humanos , Moxibustão/efeitos adversos , Doença Inflamatória Pélvica/metabolismo , Fator de Crescimento Transformador beta1/análise , Escala Visual Analógica
5.
Medicine (Baltimore) ; 99(35): e21881, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871917

RESUMO

BACKGROUND: Pain control after total knee arthroplasty has shown many advances; however, the optimal method remains controversial. The purpose of this present study is to assess the efficacy and safety of the addition of local infiltration analgesia to adductor canal block for pain control after primary total knee arthroplasty. METHODS: This prospective randomized controlled research was conducted from January 2018 to June 2019. All the patients and their family members signed the informed consent forms, and this work was authorized via the ethics committee of Jinxiang Hospital Affiliated to Jining Medical College (JXHP0024578). Inclusion criteria were 55 years old or older, who possess the physical status I-III of American Society of Anesthesiologists, and the body mass index in the range of 18 to 30 kg/m. Exclusion criteria were regional and/or neuroaxial anesthesia contraindications, the history of drug allergy involved in the research, neuropathic pain, as well as the chronic pain requiring opioid therapy. Seventy-two patients were divided into 2 groups randomly. Study group (n = 36) received both adductor canal block and local infiltration analgesia. Control group (n = 36) received adductor canal block alone. Primary outcome included postoperative pain score (visual analog scale 0 to 10 cm, in which 0 represents no pain and 10 represents the most severe imaginable pain). The measures of secondary outcome included the knee range of motion, opioid consumption, the hospital stay length as well as the postoperative complications (for instance, pulmonary embolism, deep vein thrombosis, and the wound infection). All the analyses were conducted through utilizing the SPSS for Windows Version 20.0. RESULTS: The results will be shown in .(Table is included in full-text article.) CONCLUSION:: The study will provide more evidence on the combination use of adductor canal block and local infiltration analgesia in the treatment of pain after the total knee arthroplasty. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5832).


Assuntos
Anestésicos Locais/administração & dosagem , Artroplastia do Joelho , Bloqueio Nervoso , Dor Pós-Operatória/tratamento farmacológico , Analgésicos Opioides/uso terapêutico , Bupivacaína/administração & dosagem , Humanos , Injeções Intra-Articulares , Articulação do Joelho , Tempo de Internação , Ensaios Clínicos Controlados Aleatórios como Assunto , Amplitude de Movimento Articular , Ropivacaina/administração & dosagem , Escala Visual Analógica
6.
Medicine (Baltimore) ; 99(39): e22330, 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32991444

RESUMO

RATIONALE: Widely applied in the treatment of severe ankle arthritis (AA), ankle distraction arthroplasty (ADA) can avoid not only the ankle range of motion loss but also ankle fusion. However, the clinical outcomes of ADA for severe AA are poorly understood. This study aims to present our clinical outcomes of severe AA treated by ADA. PATIENT CONCERNS: A 53-year-old man suffered right ankle sprain 10 years ago, endured right ankle pain and limited movement for 6 years. DIAGNOSIS: The patient was diagnosed as severe AA. INTERVENTIONS: He received ankle distraction arthroplasty. No adjuvant procedures were performed. The visual analog scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) score, the short-form (SF)-36 physical component summary (PCS) score and ankle activity score (AAS) were recorded to access the clinical outcomes pre- and postoperatively. Moreover, ankle joint space distance was evaluated on weight-bearing radiographs. OUTCOMES: The patient derived effective pain relief and restored a satisfactory range of movement. There was a 13-month follow-up period after frame removal. The AOFAS score improved from 56 preoperatively to 71 postoperatively. The VAS score decreased from 6 prior to surgery to 1 after surgery. The SF-36 PCS was 47.2 and 71.8 pre- and postoperative, respectively. The AAS scores were improved from 3.4 preoperatively to 7.3 postoperatively. LESSONS: ADA is reliable to achieve pain relief, functional recovery, and serve AA resolution. Besides, it is an alternative to ankle arthrodesis or total ankle arthroplasty in selected patients with severe AA.


Assuntos
Traumatismos do Tornozelo/complicações , Articulação do Tornozelo/patologia , Artrite/cirurgia , Osteogênese por Distração/efeitos adversos , Assistência ao Convalescente , Traumatismos do Tornozelo/fisiopatologia , Articulação do Tornozelo/diagnóstico por imagem , Artroplastia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Osteogênese por Distração/instrumentação , Radiografia/métodos , Amplitude de Movimento Articular , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Resultado do Tratamento , Escala Visual Analógica , Suporte de Carga
7.
Medicine (Baltimore) ; 99(39): e22369, 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32991456

RESUMO

BACKGROUND: Tarsal tunnel syndrome (TTS) is a painful condition of the ankle that affects patients' quality of life and ability to work. Multiple clinical studies of nerve decompression by acupotomy have been published in China, and the results are encouraging. However, the efficacy and security of this treatment have not been evaluated scientifically and systematically. The purpose of this systematic review protocol is to evaluate the efficacy and security of acupotomy treatment in patients with TTS, which will be helpful to clinical acupotomy doctors. METHODS: Relevant randomized controlled trials will be identified by searching 9 databases (PubMed, Embase, Cochrane Library, Chinese literature databases, the Chinese Biomedical Literature Database, China National Knowledge Infrastructure, SinoMed, Technology Journal and the Wanfang Database. Randomized controlled trials examining the use of acupotomy for TTS patients will be identified independently by 2 reviewers by searching the databases from inception to March 2020. Clinical effects will be evaluated as the primary outcome. Visual analog scale scores will be assessed as a secondary outcome. Review Manager 5.3 will be used to perform a fixed effects meta-analysis, and the evidence level will be evaluated by using the Grading of Recommendations Assessment, Development, and Evaluation framework. Continuous outcomes will be presented as mean differences or standard mean differences, while dichotomous data will be expressed as relative risks. RESULTS: This study will evaluate the effectiveness and safety of acupotomy in the treatment of TTS in randomized controlled trials with high-quality visual analog scale and Roles and Maudsley score. CONCLUSION: This systematic review will provide evidence to determine whether acupotomy is an effective intervention for patients with TTS. REGISTRATION NUMBER: DOI 10.17605/OSF. IO/9PYC2 (https://osf.io/9pyc2/).


Assuntos
Terapia por Acupuntura/métodos , Síndrome do Túnel do Tarso/terapia , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Escala Visual Analógica
8.
Medicine (Baltimore) ; 99(37): e22204, 2020 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-32925797

RESUMO

Many surgical procedures have been developed for the treatment of post-traumatic thoracolumbar kyphosis. But there is a significant controversy over the ideal management. The aim of this study was to illustrate the technique of modified grade 4 osteotomy for the treatment of post-traumatic thoracolumbar kyphosis and to evaluate clinical and radiographic results of patients treated with this technique.From May 2013 to May 2018, 42 consecutive patients experiencing post-traumatic thoracolumbar kyphosis underwent the technique of modified grade 4 osteotomy, and their medical records were retrospectively collected. Preoperative and postoperative sagittal Cobb angle, visual analog scale (VAS), Oswestry disability index (ODI), and American Spinal Injury Association (ASIA) were recorded. The average follow-up period was 29.7 ±â€Š14.2 months.The operation time was 185.5 ±â€Š26.8 minutes, the intraoperative blood loss was 545.2 ±â€Š150.1 mL. The Cobb angles decreased from 38.5 ±â€Š3.8 degree preoperatively to 4.2 ±â€Š2.6 degree 2 weeks after surgery (P < .001). The VAS reduced from 6.5 ±â€Š1.1 preoperatively to 1.5 ±â€Š0.9 at final follow-up (P < .001), and the ODI reduced from 59.5 ±â€Š15.7 preoperatively to 15.9 ±â€Š5.8 at final follow-up (P < .001). Kyphotic deformity was successfully corrected and bony fusion was achieved in all patients. Neurologic function of 7 cases was improved to various degrees.Modified grade 4 osteotomy, upper disc, and upper one-third to half of pedicle are resected, is an effective treatment option for post-traumatic thoracolumbar kyphosis. However, the long-term clinical effect still needs further studies.


Assuntos
Cifose/cirurgia , Vértebras Lombares/cirurgia , Osteotomia/métodos , Vértebras Torácicas/cirurgia , Adulto , Idoso , Perda Sanguínea Cirúrgica , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Retrospectivos , Escala Visual Analógica
9.
Medicine (Baltimore) ; 99(36): e21957, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899030

RESUMO

INTRODUCTION: Although there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients. METHODS AND ANALYSIS: This study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment. CONCLUSION: The trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis. TRIAL REGISTRATION NUMBER: KCT0004844.


Assuntos
Terapia por Acupuntura/métodos , Osteoartrite do Joelho/terapia , Terapia por Acupuntura/efeitos adversos , Humanos , Medição da Dor/métodos , Polidioxanona/uso terapêutico , Escala Visual Analógica
10.
Medicine (Baltimore) ; 99(36): e22070, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899074

RESUMO

BACKGROUND: A number of recent studies have investigated the optimal dosage and timing of dexamethasone in total hip arthroplasty (THA) but have inconsistent findings. Therefore, we designed the randomized controlled research to look for the optimal intravenous dexamethasone dose for the treatment of early postoperative pain after the THA. METHODS: The Declaration of Helsinki principles was followed and the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials was adhered in this study. The First Medical Center in People's Liberation Army General Hospital approved the study (2020-089). After written informed consent was obtained, patients aged between 18 and 80 years with Physical Status I to III of American Society of Anesthesiologists, scheduled for primary unilateral THA, were included in this present work. Randomization is the use of a computer-formed list via a secretary, at a ratio of 1:1:1. The major end points were pain scores at 24 hours, 48 hours, and 72 hours after surgery, with visual analog scale (VAS) utilized at rest, and at 45 degrees passive hip flexion. The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay. RESULTS: We assumed that the patients who received 3 doses of dexamethasone intravenously possessed the best postoperative results compared to those who received 1 or 2 doses of the dexamethasone. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5864).


Assuntos
Anti-Inflamatórios/administração & dosagem , Artroplastia de Quadril/efeitos adversos , Dexametasona/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Administração Intravenosa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios/uso terapêutico , Estudos de Casos e Controles , Dexametasona/uso terapêutico , Humanos , Mediadores da Inflamação/metabolismo , Tempo de Internação , Pessoa de Meia-Idade , Morfina/efeitos adversos , Entorpecentes/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Amplitude de Movimento Articular , Escala Visual Analógica , Adulto Jovem
11.
Medicine (Baltimore) ; 99(31): e21444, 2020 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-32756160

RESUMO

BACKGROUND: Currently, there is some clinical evidence supporting the use of acupuncture in alleviating pain and dysfunction in patients with lumbar spinal stenosis (LSS). However, the question of whether acupuncture could be efficacious for ageing patients remains unanswered. We designed a randomized controlled study to evaluate the safety and feasibility of acupuncture for participants with symptomatic LSS. METHODS: This study is a randomized, single-blind, noninferiority trial. This clinical trial was approved by the Linyi Cancer Hospital. We received informed consent from all patients before surgery. In preparing this report, we adhered to the Consolidated Standards of Reporting Trials guidelines. We randomized consented study participants on a 1:1 ratio to one of two study groups (acupuncture and control groups) using a computer-generated list of random numbers in varying block sizes. Three outcome measures were selected to evaluate the effectiveness and safety of the treatment: visual analogue score and Oswestry disability index, and complicatins. A P < .05 was regarded as statistically significant. RESULTS: The hypothesis was that the acupuncture group would achieve acceptable clinical outcomes as compared to the control group in LSS. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5744).


Assuntos
Terapia por Acupuntura/métodos , Vértebras Lombares/patologia , Estenose Espinal/terapia , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Estudos de Viabilidade , Humanos , Vértebras Lombares/diagnóstico por imagem , Imagem por Ressonância Magnética/métodos , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Segurança , Método Simples-Cego , Resultado do Tratamento , Escala Visual Analógica
12.
Medicine (Baltimore) ; 99(31): e21450, 2020 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-32756165

RESUMO

BACKGROUND: Ankylosing spondylitis (AS) is a common progressive autoimmune inflammatory disease. Du moxibustion can effectively treat AS with few adverse reactions. The aim of this protocol is to systematically investigate the effectiveness and safety for management of AS with Du moxibustion. METHODS: Seven relevant databases, namely, PubMed, Cochrane Library, Embase, Chinese Biomedical Literatures Database (CBM), China National Knowledge Infrastructure (CNKI), WangFang Database (WF), Chinese Scientific Journal Database (VIP) will be searched from their inception until May 1st, 2020. All clinical randomized controlled trials containing eligible interventions(s) and outcome(s) will be included, regardless of blinding or publication types. Two reviewers will independently retrieval databases, extract data, and then assess the quality of studies. Data synthesis will be conducted by RevMan 5.3 software. We regard the effective rate, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Visual Analogue Scale (VAS) as the primary outcomes, and the secondary outcomes contain C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), finger-to-floor distance (FFD), occiput to wall distance (OWD), and side effects. The result about the curative effect and safety of Du moxibustion for AS will be presented as risk ratio for dichotomous data and mean differences with a 95% confidence interval for continuous data. RESULTS: The finding will be presented in a journal or related conferences. CONCLUSIONS: This study expects to provide high-quality, evidence-based recommendations on further treatment for clinical guidance. PROSPERO REGISTRATION NUMBER: CRD42020158727.


Assuntos
Moxibustão/métodos , Espondilite Anquilosante/sangue , Espondilite Anquilosante/terapia , Sedimentação Sanguínea , Proteína C-Reativa/análise , Bases de Dados como Assunto , Humanos , Moxibustão/efeitos adversos , Prevalência , Ensaios Clínicos Controlados Aleatórios como Assunto , Espondilite Anquilosante/epidemiologia , Resultado do Tratamento , Escala Visual Analógica
13.
Medicine (Baltimore) ; 99(30): e21313, 2020 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-32791720

RESUMO

BACKGROUND: Congenital auricular deformities (CAD) are prevalent worldwide. The objective of this study is to investigate the effectiveness and safety of ear molding for children with CAD at their early days. METHODS: One hundred and nighty children (under 3 days) with CAD will be included in the study. Participants will be randomly allocated to treatment or waiting list group (n = 95). The treatment group will receive ear molding within 3 days after birth for 2 weeks. The control group will receive usual care and receive the same ear molding at 6th week if spontaneously recover is not occur. Physician and parent assessment of improvement, parent's anxiety, depression, and quality of life and adverse events will be measured at baseline, 3rd and 6th week of initial treatment. The primary outcome recovery rate will be compared between groups using Chi square test. Secondary continuous outcomes will be compared using analysis of variance. DISCUSSION: This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.


Assuntos
Microtia Congênita/epidemiologia , Análise Custo-Benefício/métodos , Orelha/anormalidades , Auxiliares de Audição/efeitos adversos , Estudos de Casos e Controles , Tomada de Decisão Clínica , Orelha/patologia , Auxiliares de Audição/estatística & dados numéricos , Humanos , Recém-Nascido , Pais/psicologia , Qualidade de Vida , Segurança , Resultado do Tratamento , Escala Visual Analógica , Listas de Espera
14.
Medicine (Baltimore) ; 99(32): e21580, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769907

RESUMO

BACKGROUND: We aim to perform a network meta-analysis (NMA) to quantify and rank-order the efficacy and safety of analgesic medications for ambulatory surgery. METHODS: We will search MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and Google Scholar databases to identify all randomized controlled trials (RCTs) of analgesics, beginning from their inception to February 2020. The primary endpoints will be pain score measured using a visual analog scale (VAS) or a numerical rating scale (NRS) at 3 different time points: Phase I recovery, phase II recovery, and recovery at home. Adverse events, including nausea, vomiting, headache, dizziness, arrhythmia, and respiratory depression, will be also assessed.We will conduct NMA and use surface under the cumulative ranking curve (SUCRA) values and rankograms to present the hierarchy of analgesic medication. A comparison-adjusted funnel plot will be used to assess the presence of small study effects. The quality of the included studies will be assessed using the risk of bias tool 2.0. All statistical analyses will be performed using Stata SE version 15.0. RESULTS: The results of this systematic review and NMA will be published in a peer-reviewed journal. CONCLUSION: This systematic review and NMA will provide comprehensive and convincing evidence regarding analgesic medication for pain after ambulatory surgery. TRIAL REGISTRATION NUMBER: CRD42018100000.


Assuntos
Procedimentos Cirúrgicos Ambulatórios/métodos , Analgésicos/normas , Protocolos Clínicos , Analgésicos/uso terapêutico , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Escala Visual Analógica
15.
Medicine (Baltimore) ; 99(32): e21611, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769919

RESUMO

BACKGROUND: Low back pain (LBP) affects approximately 51% to 57% of hospital nurses and nurses' aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP. METHODS AND ANALYSIS: We conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to 2 groups: intervention group, where patients received LED photobiomodulation therapy 3 times a week for 2 weeks, and the sham group, where patients had sham therapy 3 times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index. The outcome measures were assessed before therapy and 2weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed. DISCUSSION: This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. Our results will be useful for patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain. TRIAL REGISTRATION NUMBER: NCT04424823.


Assuntos
Protocolos Clínicos , Dor Lombar/terapia , Terapia com Luz de Baixa Intensidade/normas , Enfermeiras e Enfermeiros/estatística & dados numéricos , Adolescente , Adulto , Idoso , Dor Crônica/terapia , Método Duplo-Cego , Humanos , Terapia com Luz de Baixa Intensidade/instrumentação , Terapia com Luz de Baixa Intensidade/métodos , Pessoa de Meia-Idade , Manejo da Dor/métodos , Manejo da Dor/normas , Medição da Dor/métodos , Estudos Prospectivos , Inquéritos e Questionários , Escala Visual Analógica
16.
Medicine (Baltimore) ; 99(30): e21221, 2020 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-32791696

RESUMO

To decrease postoperative complications in patients with adult lumbar degenerative scoliosis (ALDS), short-segment fusion surgery was used in this study. However, the incidence of adjacent segment disease was found to be remarkable. Therefore, we applied the hybrid treatment (short-segment fusion for responsibility levels plus nonfusion stabilization of lumbar segments, which was called the Wallis system, for the proximal level) to patients enrolled into this study. The purpose of this study was to investigate the feasibility of a novel hybrid therapeutic approach for treating patients with ALDS.From January 2011 to January 2017, a retrospective study was conducted consisting of 16 patients with ALDS who were treated with hybrid treatment. All patients were treated with short-segment decompression and fusion for responsibility levels and nonfusion stabilization of lumbar segments for the proximal levels. The imaging outcomes were evaluated preoperatively and at the time of follow-up.The mean visual analog score for back pain decreased from 6.1 ±â€Š2.0 preoperatively to 2.1 ±â€Š0.7 at 2-year follow-up (P < .05), and the mean visual analog score for leg pain reduced from 8.1 ±â€Š0.6 preoperatively to 1.3 ±â€Š0.8 at 2-year follow-up (P < .05). The Oswestry disability index scores improved from 65.4 ±â€Š16.3% preoperatively to 18.3 ±â€Š5.6% at 2-year follow-up (P < .05). The mean Cobb angle was 22.1 ±â€Š6.2° preoperatively, and 13.8 ±â€Š6.8° at 2-year follow-up (P < .05). The lumbar lordosis changed from -40.4 ±â€Š14.8° to -43.5 ±â€Š11.2° at 2-year follow-up (P < .05). Solid fusion was achieved in all the patients, and no incidence of adjacent segment disease was noted as well.The proposed hybrid treatment for patients with ALDS can achieve favorable clinical outcomes and a lower incidence of ALDS. However, the correction of deformity is still limited that highlights the necessity of further study.


Assuntos
Discotomia/métodos , Vértebras Lombares/cirurgia , Escoliose/cirurgia , Fusão Vertebral/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Resultado do Tratamento , Escala Visual Analógica
17.
Neurology ; 95(7): e878-e888, 2020 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-32747522

RESUMO

OBJECTIVE: To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM). METHODS: HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12. RESULTS: The full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all, p < 0.05) to week 12. At week 12, fremanezumab also showed significant improvements in EQ-5D-5L visual analog scale (p < 0.05) and PGIC scores (p < 0.0001) as well as significant reductions from baseline in WPAI:GH scores (p < 0.01) and presenteeism (impairment while working; p < 0.05) vs placebo. CONCLUSIONS: Fremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM. CLINICALTRIALSGOV IDENTIFIER: NCT02621931. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Dor Crônica/tratamento farmacológico , Transtornos de Enxaqueca/tratamento farmacológico , Qualidade de Vida , Adulto , Doença Crônica , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/complicações , Inquéritos e Questionários , Escala Visual Analógica , Desempenho Profissional
18.
Yonsei Med J ; 61(7): 635-639, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32608208

RESUMO

Cavovarus deformity is considered an anatomical risk factor for chronic lateral ankle instability (CLAI). However, subtle deformity can be difficult to detect, and its correction is controversial. The current study aimed to evaluate clinical and radiographic outcomes of a modified Broström procedure (MBP) with additional procedures for CLAI with subtle cavovarus deformity and a positive peek-a-boo heel sign. We reviewed the records of 15 patients who underwent MBP with additional procedures for CLAI with a positive peek-a-boo heel sign between August 2009 and April 2015. Consecutive physical and radiographic examinations were performed. The visual analog scale (VAS) for pain, the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, and the Karlsson-Peterson (KP) ankle score were applied to assess clinical outcomes. Weight bearing radiographs, hindfoot alignment view, and ankle stress radiographs were also examined. The mean follow-up period was 58.5 months. Calcaneal lateral closing wedge osteotomy was performed in seven patients to correct fixed hindfoot varus, and first metatarsal dorsiflexion osteotomy was performed in 11 patients to correct plantarflexion of the first ray. Three patients underwent both procedures. Mean VAS, AOFAS, and KP ankle scores improved significantly (p=0.001), and instability did not recur. Radiographically, all stress parameters improved significantly (p=0.007). Simultaneous correction of a positive peek-a-boo heel sign and cavovarus deformity with MBP for CLAI improves clinical outcomes and prevents recurrent instability. A comprehensive evaluation and cautious approach for subtle cavovarus deformity should be followed when treating patients with CLAI. This trial is registered on Clinical Research Information Service (CRiS, KCT0003287).


Assuntos
Articulação do Tornozelo/cirurgia , Instabilidade Articular/cirurgia , Osteotomia/métodos , Adulto , Tornozelo/diagnóstico por imagem , Tornozelo/fisiopatologia , Articulação do Tornozelo/diagnóstico por imagem , Feminino , , Calcanhar/diagnóstico por imagem , Calcanhar/fisiopatologia , Humanos , Instabilidade Articular/diagnóstico , Instabilidade Articular/diagnóstico por imagem , Masculino , Ossos do Metatarso , Metatarso/diagnóstico por imagem , Metatarso/cirurgia , Pessoa de Meia-Idade , Radiografia , Procedimentos Cirúrgicos Reconstrutivos , Recuperação de Função Fisiológica , Pé Cavo/diagnóstico por imagem , Pé Cavo/cirurgia , Resultado do Tratamento , Escala Visual Analógica
19.
Medicine (Baltimore) ; 99(28): e20907, 2020 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-32664084

RESUMO

BACKGROUND: The increasing prevalence of osteoarthritis among the old population worldwide is a great concern. Two of the biggest complaints of OA patients are joint pain and inflammation. Currently, people are relying on non-steroidal anti-inflammatory drugs (NSAIDs) and steroids to control pain and inflammation. However, long-term use of these pharmaceutical drugs has negative health consequences in the elderly, including gastro-intestinal, respiratory, and renal diseases. Natural products are receiving more attention than ever as alternative treatments against OA for their efficacies and safety. The root of Paeonia lactiflora Pal and the gum resin of Commiphora myrrha have been used as analgesics and anti-inflammatory agents since ancient time. A new herbal formula composed of P. lactiflora root and C. myrrha gum resin extracts, known as HT083, has shown promising antinociceptive and anti-inflammatory effects in a rodent model of OA. We design this study to investigate the safety and the efficacy of HT083 to prevent OA in patients with mild OA. METHODS: This is a randomized, double-blind, and placebo-controlled study. A total of 100 eligible participants will be divided into two groups and will be given HT083 and a placebo for 12 weeks in 1:1 ratio. Treatment results will be assessed using a visual analog scale (VAS), Korean-Short Form health survey-36 score (SF-36), personal evaluation, and laboratory analysis. DISCUSSION: This trial is expected to provide clinical evidence on the effectiveness and the safety of HT083 as a natural treatment for mild OA. TRIAL REGISTRATION: Korean Clinical Research Information Service (CRIS) number KCT0004925 Registered on 2020.04.16.


Assuntos
Artralgia/tratamento farmacológico , Indóis/uso terapêutico , Inflamação/tratamento farmacológico , Medicina Tradicional Chinesa/métodos , Osteoartrite do Joelho/tratamento farmacológico , Pirróis/uso terapêutico , Adulto , Idoso , Analgésicos/uso terapêutico , Animais , Anti-Inflamatórios/uso terapêutico , Commiphora/efeitos adversos , Commiphora/química , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/epidemiologia , Osteoartrite do Joelho/patologia , Paeonia/efeitos adversos , Paeonia/química , Placebos/administração & dosagem , República da Coreia/epidemiologia , Roedores , Segurança , Resultado do Tratamento , Escala Visual Analógica
20.
Medicine (Baltimore) ; 99(28): e20911, 2020 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-32664086

RESUMO

BACKGROUND: Allergic rhinitis (AR) is a common allergic disorder worldwide. Western medicine is not optimistic about the therapeutic effect of this disease. However, moxibustion can enhance vital energy or immunity through a great number of clinical trials. Thus, the aim of this systematic review and meta-analysis is to systematically evaluate the effectiveness and safety of indirect moxibustion for treating AR. METHODS: We will conduct a comprehensive literature search in Medline, PubMed, Web of Science, Embase, the Cochrane Library, China National Knowledge Infrastructure Database, WanFang Database, Chinese Scientific Journal Database, and Chinese Biomedical Literature Database from inception to August 2020 without any language restriction. In addition, we will retrieve the unpublished studies and the references of initially included literature manually. Reviewers will identify studies, extract data, and assess the quality independently. The outcomes of interest include: total effective rate, total nasal symptom score, total non-nasal symptom score, rhinitis quality of life questionnaire, visual analog scale, laboratory indicators (i.e., serum levels of IgE, IgA, or IgG), and adverse events. Randomized clinical trials will be collected, methodological quality will be evaluated using the Cochrane risk-of-bias assessment tool, and the level of evidence will be rated using the Grading of Recommendations, Assessment, Development and Evaluation approach. Meta-analysis will be performed using RevMan 5.3.0 software. The heterogeneity test will be conducted between the studies, and P < .1 and I > 50% are the thresholds for the tests. We will utilize the fixed effects model or the random effects model according to the size of heterogeneity. RESULTS: Because the review is ongoing, no results can be reported. CONCLUSIONS: The results of this review will provide reliable evidence for effectiveness and safety of indirect moxibustion for treating AR. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. This systematic review and meta-analysis will be disseminated online and on paper to help guide clinicians. PROSPERO REGISTRATION NUMBER: CRD42019140944.


Assuntos
Imunidade/efeitos dos fármacos , Moxibustão/métodos , Rinite Alérgica/terapia , China/epidemiologia , Humanos , Imunoglobulina A/sangue , Imunoglobulina E/sangue , Imunoglobulina G/sangue , Moxibustão/efeitos adversos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Rinite Alérgica/epidemiologia , Rinite Alérgica/psicologia , Segurança , Resultado do Tratamento , Escala Visual Analógica
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