ABSTRACT
Introdução: A apneia obstrutiva do sono (AOS) é o distúrbio respiratório do sono mais comum. O treino muscular respiratório tem surgido como uma intervenção promissora para a melhora dos sintomas e com boa adesão, porém muito ainda se tem discutido sobre sua efetividade e segurança. Objetivo: Avaliar a efetividade e segurança do TMR no tratamento de pacientes com AOS. Métodos: Para tanto, realizaremos uma revisão sistemática de ensaios clínicos randomizados (ECR). O protocolo do estudo foi registrado na Plataforma Prospero (CRD42018096980). Incluiremos indivíduos de idade superior ou igual a 18 anos, com diagnóstico de AOS, em uso ou não de pressão positiva nas vias aéreas. Excluiremos estudos com pacientes diagnosticados com lesão da medula espinhal ou doenças neuromusculares. As buscas serão realizadas nas bases de dados: Medical Literature Analysis and Retrieval System Online (Medline) via Pubmed, Excerpta Medica dataBASE (Embase) via Elsevier, Cochrane Central Register of Controlled Trials (Central) via Cochrane Library, Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs) via Portal da Biblioteca Virtual em Saúde e Physiotherapy Evidence Database (PEDro), sem restrições de idioma ou ano de publicação. Avaliaremos o rigor metodológico dos estudos incluídos e a certeza da evidência dos principais desfechos da revisão sistemática utilizando a ferramenta Risco de Viés 2.0 da Cochrane e a abordagem Grading of Recommendations Assessment, Development and Evaluation (GRADE), respectivamente. A seleção dos estudos, extração de dados, avaliação do viés dos estudos incluídos e avaliação da certeza da evidência serão realizados por dois pesquisadores independentes. Resultados esperados: Espera-se que os resultados desta revisão forneçam informações úteis para a tomada de decisão clínica, exponham lacunas de conhecimento, assim como forneçam um bom embasamento para futuros ECR de alta qualidade sobre o assunto.
ABSTRACT
BACKGROUND: The co-occurrence of chronic pain and sleep disturbance contribute to a significant functional and social impact in older adults. However, there are no validated instruments to measure sleep disturbance and pain in this population that could be used to screen or diagnose individuals or monitor treatment effectiveness. OBJECTIVE: Our aim was to develop and validate a brief, practical, and comprehensive tool to assess the impact of co-occurring pain and sleep disturbance in older adults. METHODS: Development and validation of a measurement tool for assessing pain and sleep in older adults consisting of seven items. RESULTS: We applied the "Sleep Assessment Instrument for Pain in older adults" (SAIOAP) in a sample of 100 older individuals. A Cronbach's alpha of 0.602 indicated a moderate level of reliability, and item-total correlations of ≥0.4 for all items indicated good homogeneity. There were statistically significant correlations between the SAIOAP and sleep quality (PSQI, r=61.5), pain intensity (VNS, r=30.5), the multidimensional impacts of pain (GPM, r=40.5), depression (GEAP, r=45.5), comorbidity (r=27.9), and medication use (r=30.4). A ROC curve indicated a sensitivity of 73.2% and a specificity of 79.1% in relation to the prediction of sleep disturbances associated with pain in older adults. CONCLUSIONS: The SAIOAP presented adequate metric properties and was demonstrated to be a simple and practical tool for the assessment of the impact of pain on sleep in older adults.
Subject(s)
Chronic Pain , Aged , Chronic Pain/diagnosis , Humans , Pain Measurement , Psychometrics , Reproducibility of Results , Sleep , Surveys and QuestionnairesABSTRACT
Abstract Background: The co-occurrence of chronic pain and sleep disturbance contribute to a significant functional and social impact in older adults. However, there are no validated instruments to measure sleep disturbance and pain in this population that could be used to screen or diagnose individuals or monitor treatment effectiveness. Objective: Our aim was to develop and validate a brief, practical, and comprehensive tool to assess the impact of co-occurring pain and sleep disturbance in older adults. Methods: Development and validation of a measurement tool for assessing pain and sleep in older adults consisting of seven items. Results: We applied the "Sleep Assessment Instrument for Pain in older adults" (SAIOAP) in a sample of 100 older individuals. A Cronbach's alpha of 0.602 indicated a moderate level of reliability, and item-total correlations of ≥0.4 for all items indicated good homogeneity. There were statistically significant correlations between the SAIOAP and sleep quality (PSQI, r=61.5), pain intensity (VNS, r=30.5), the multidimensional impacts of pain (GPM, r=40.5), depression (GEAP, r=45.5), comorbidity (r=27.9), and medication use (r=30.4). A ROC curve indicated a sensitivity of 73.2% and a specificity of 79.1% in relation to the prediction of sleep disturbances associated with pain in older adults. Conclusions: The SAIOAP presented adequate metric properties and was demonstrated to be a simple and practical tool for the assessment of the impact of pain on sleep in older adults.
RESUMO Introdução: A co-ocorrência de dor crônica e de distúrbios do sono contribuem para um impacto funcional e social negativo em idosos. Porém, o binômio dor-sono não foi explorado em relação a questionários para idosos, a fim de auxiliar na triagem, no diagnóstico ou no monitoramento da eficácia do tratamento médico. Objetivo: Desenvolver e validar um instrumento breve, prático e abrangente para avaliar a concorrência de condições álgicas crônicas e distúrbios de sono em idosos. Métodos: Estudo descritivo e qualitativo de metodologia de desenvolvimento e validação de instrumento de medida para avaliação de dor e sono em idosos, composto por sete itens. Após a fundamentação teórica, desenvolveram-se os itens do instrumento, seguidos de um estudo quantitativo (validação), em que testamos pacientes idosos com dor crônica. Resultados: Aplicou-se o Instrumento de Avaliação de Sono para Dor em Idosos (IASID) a uma amostra de 100 idosos. Alcançou-se o alfa de Cronbach (0,602) de boa homogeneidade por correlação item-total (≥0,4). Encontramos correlações estatisticamente significativas entre o IASID e a qualidade do sono (PSQI, r=61,5%); a intensidade da dor (NVS, r=30,5%); seus impactos (GPM, r=40,5); depressão (GEAP, r=45,5%); comorbidades (r=27,9) e uso de medicamentos (r=30,4). A curva ROC apontou sensibilidade de 73,2% e especificidade de 79,1% para predição de distúrbios do sono associados à dor crônica em idosos. Conclusões: O IASID apresentou propriedades métricas adequadas e demonstrou ser uma ferramenta simples e prática para a avaliação do impacto da dor no sono em idosos.
Subject(s)
Humans , Aged , Chronic Pain/diagnosis , Psychometrics , Sleep , Pain Measurement , Surveys and Questionnaires , Reproducibility of ResultsABSTRACT
BACKGROUND: Although evidence has indicated a positive effect of transcranial direct current stimulation (tDCS) on reducing pain, few studies have focused on the elderly population with knee osteoarthritis (KOA). OBJECTIVE: To evaluate whether tDCS reduces KOA pain in elderly individuals with a dysfunctional descending pain inhibitory system (DPIS). METHODS: In a double-blind trial, individuals ≥ 60 years with KOA pain and a dysfunctional DPIS, we randomly assigned patients to receive 15 daily sessions of 2 mA tDCS over the primary motor cortex (anode) and contralateral supraorbital area (cathode) (M1-SO) for 20 min or sham tDCS. Change in pain perception indexed by the Brief Pain Inventory (BPI) at the end of intervention was the primary outcome. Secondary outcomes included: disability, quantitative sensory testing, pain pressure threshold and conditioned pain modulation (CPM). Subjects were followed-up for 2 months. RESULTS: Of the 104 enrolled subjects, with mean (SD) age of 73.9 (8.01) years and 88 (84.6%) female, 102 finished the trial. In the intention-to-treat analysis, the active tDCS group had a significantly greater reduction in BPI compared to the sham group (difference, 1.59; 95% CI, 0.95 to 2.23; P < 0.001; Cohen's d, 0.58); and, also a significantly greater improvement in CPM-pressure in the knee (P = 0.01) and CPM-pain in the hand (P = 0.01). These effects were not sustained at follow-up. The intervention was well tolerated, with no severe adverse effects. CONCLUSION: M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation. This intervention has also shown to modulate the DPIS.
Subject(s)
Motor Cortex , Osteoarthritis, Knee , Transcranial Direct Current Stimulation , Aged , Double-Blind Method , Female , Hand , Humans , Osteoarthritis, Knee/complications , Osteoarthritis, Knee/therapy , PainABSTRACT
BACKGROUND: Transcranial direct-current stimulation (tDCS) has shown promise to decrease fatigue. However, it has never been examined in primary Sjogren Syndrome (pSS). OBJECTIVE: To assess the effect of a tDCS protocol on fatigue in patients with pSS. METHODS: This is a parallel, double-blind pilot study (NCT04119128). Women aged 18-65 years, with pSS, on stable pharmacological therapy, with complaints of fatigue for at least three months, and with scores >5 on Fatigue Severity Scale (FSS) were included. We randomized 36 participants to receive five consecutive or sham tDCS sessions, with an intensity of 2 mA, for 20 min/day. RESULTS: After five tDCS sessions, fatigue severity assessed by the FSS (primary outcome) demonstrated a mean group difference of -0.85 [95% confidence interval (CI) -1.57, -0.13; effect size 0.80] favouring the active group. The active group presented significantly greater reductions in fatigue as measured by the EULAR Sjögren's Syndrome Patient Reported Index after five tDCS sessions [mean group difference: 1.40; 95%CI -2.33, -0.48; effect size 1.04]. Although there were no between-group differences in the secondary outcomes of sleep, mood and anxiety, within-group comparisons evidenced a small but significant difference in the active group for pain and sleep. There were no significant cortisol changes. All reported adverse events were mild and transitory. CONCLUSION: tDCS seems to be safe and reduce fatigue in pSS. A differential effect on pain and sleep may underlie its effects. Further studies are needed to optimise tDCS treatment strategies in pSS.
Subject(s)
Sjogren's Syndrome , Transcranial Direct Current Stimulation , Double-Blind Method , Fatigue/etiology , Fatigue/therapy , Female , Humans , Pilot Projects , Sjogren's Syndrome/complications , Sjogren's Syndrome/therapyABSTRACT
BACKGROUND: Knee osteoarthritis (OA) has been the main cause behind chronic pain and disabilities in the elderly population. The traditional treatment for knee OA pain currently concerns a number of combinations of pharmacological and nonpharmacological therapies. However, such combinations have displayed little effects on a significant group of subjects. In addition to this, pharmacological treatments often cause adverse effects, which limits their use on this population. Previous studies showed that chronic knee OA pain may be associated with maladaptive compensatory plasticity in pain-related neural central circuits indexed by a defective descending pain-inhibitory system. Transcranial direct current stimulation (tDCS) can revert some of these maladaptive changes, thus decreasing chronic pain sensation. Numerous studies have demonstrated that the use of anodal tDCS stimulation over the primary motor cortex (M1) has positive effects on chronic neuropathic pain. Yet, data on OA pain in elderly patients, including its effects on the endogenous pain-inhibitory system, remain limited. OBJECTIVE: The objective of this study is to evaluate the efficacy of tDCS in reducing pain intensity caused by knee OA in elderly subjects with defective endogenous pain-inhibitory systems. METHODS: We designed a randomized, sham-controlled, single-center, double-blinded clinical trial. Patients with knee OA who have maintained a chronic pain level during the previous 6 months and report a pain score of 4 or more on a 0-10 numeric rating scale (NRS) for pain in that period will undergo a conditioned pain modulation (CPM) task. Participants who present a reduced CPM response, defined as a decrease in NRS during the CPM task of less than 10%, and meet all of the inclusion criteria will be randomly assigned to receive 15 sessions of 2 mA active or sham tDCS for 20 minutes. A sample size of 94 subjects was calculated. The Brief Pain Inventory pain items will be used to assess pain intensity as our primary outcome. Secondary outcomes will include pain impact on functioning, mobility performance, quality of life, CPM, pressure pain threshold, touch-test sensory evaluation, and safety. Follow-up visits will be performed 2, 4, and 8 weeks following intervention. The data will be analyzed using the principle of intention-to-treat. RESULTS: This study was approved by the institutional review board with the protocol number 1685/2016. The enrollment started in April 2018; at the time of publication of this protocol, 25 subjects have been enrolled. We estimate we will complete the enrollment process within 2 years. CONCLUSIONS: This clinical trial will provide relevant data to evaluate if anodal tDCS stimulation over M1 can decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will advance the investigation of the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it. TRIAL REGISTRATION: ClinicalTrials.gov NCT03117231; https://clinicaltrials.gov/ct2/show/NCT03117231 (Archived by WebCite at http://webcitation.org/73WM1LCdJ). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/11660.
