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No / Objective To compare the incidence of treatment-related complications, including lymphoedema, after two programmes of shoulder mobilisation in women with invasive breast cancer when surgical treatment included axillary lymph node dissection. Design Randomised controlled trial. Setting Two secondary care National Health Service trusts. Participants One hundred and sixteen women (mean age 57 years, standard deviation 13.1 years) recruited from November 2003 to March 2006 (58 intervention group, 58 control group). Seven patients (6%) did not complete the study. Intervention Arm exercises and shoulder movement restricted to below shoulder level for the first 7 days after surgery. Controls commenced an exercise programme that incorporated exercises above shoulder level within 48 hours. Outcome measures All outcomes were recorded at baseline (pre-operatively) and at 1 year. The primary outcome was incidence of lymphoedema, defined by a limb volume difference of 200 ml or more compared with the contralateral arm. This outcome was measured using volume displacement. Secondary outcome measures included volume differences between the two limbs measured by actual volume displacement difference, wound drainage volumes, range of shoulder movement (manual goniometer), grip strength (hand-held dynamometer) and health-related quality of life (Shoulder Disability Questionnaire, Functional Assessment of Cancer Therapy – Breast). Results All statistical tests were two-sided. Data were analysed using intention-to-treat principles. The incidence of lymphoedema (200 ml or more) increased significantly in women who had undertaken a programme of early full shoulder mobilisation. Twenty-two women (19%) developed lymphoedema (200 ml or more) in their first postoperative year. There were significantly more women with lymphoedema in the early full shoulder mobilisation group (n = 16) compared with the delayed full shoulder mobilisation group (n = 6). The relative risk of developing lymphoedema after early mobilisation was 2.7 (95% confidence interval 1.1 to 6.3; P = 0.031). Limb volume differences were significantly higher in the early mobilisation group. This was apparent in differences in limb volume displacement (P = 0.004) and percentage difference between the two limbs (P = 0.007). There were no statistically significant differences in shoulder movement, grip strength or self-evaluated outcomes between the two groups at 1 year. Conclusion A programme of exercise that delays full shoulder mobilisation for 1 week is recommended after axillary node dissection for invasive breast cancer.

No / The European RHAPSODY project sought to develop and test an online information and support programme for caregivers of individuals diagnosed with young onset dementia. The objectives were to assess user acceptability and satisfaction with the programme and to test outcome measures for a larger effectiveness study. DESIGN: A pilot randomised controlled trial in England, France, and Germany was conducted with 61 caregivers for adults with young onset Alzheimer's disease or frontotemporal degeneration. Evaluations at baseline, week 6, and week 12 assessed user acceptability and satisfaction. Use of the programme was measured from online back-end data. Qualitative feedback on user experiences was collected via semi-structured interviews. Measures of caregiver well-being (self-efficacy, stress, burden, frequency of patient symptoms, and caregiver reactions) were explored for use in a subsequent trial. RESULTS: Participants logged in online on average once a week over a 6-week period, consulting approximately 31% of programme content. Seventy percent of participants described the programme as useful and easy to use. Eighty-five percent expressed intent to use the resource in the future. Reductions in reported levels of stress and caregivers' negative reactions to memory symptoms were observed following use of the programme. CONCLUSIONS: Results indicated that the RHAPSODY programme was acceptable and useful to caregivers. The programme may be complementary to existing services in responding to the specific needs of families affected by young onset dementia. Distribution of the programme is underway in England, France, Germany, and Portugal.

Plusieurs études ont démontré que prés de deux tiers des patients subissant une chirurgie cardiaque souffrent de douleur d’intensité modérée à sévère. Ces niveaux de douleur semblent être partiellement expliqués par la présence de barrières individuelles face au soulagement de la douleur. Le savoir acquis sur les cognitions associées à la douleur ne semble pas avoir été traduit dans de nouvelles approches éducatives face à la douleur aiguë. Le but du projet doctoral était 1) de développer une intervention visant à faciliter l’autogestion de la douleur postopératoire après une chirurgie cardiaque et, 2) d’en évaluer l’acceptabilité et la faisabilité, ainsi que le potentiel d’efficacité sur le soulagement de la douleur de patients subissant une chirurgie cardiaque. Le développement de l’iintervention SOULAGE-TAVIE a inclus quatre étapes fondées sur les savoirs clinique, empirique et théorique et inspirées de plusieurs écrits méthodologiques. SOULAGE-TAVIE consiste en une session préopératoire éducative sur la gestion de la douleur post-chirurgie cardiaque d’approximativement 30 minutes sur un ordinateur, dispensée sur mesure en fonction d’un algorithme. Deux renforcements cliniques en personne sont aussi offerts en phase postopératoire. L’évaluation de l’intervention consistait en un essai clinique pilote à répartition aléatoire incluant 60 participants répartis entre le groupe expérimental (GE : SOULAGE-TAVIE) et le groupe contrôle (GC : soins usuels incluant un feuillet d’information). Les données étaient recueillies au moment de l’admission et dans les sept jours postopératoires. SOULAGE-TAVIE a été jugée comme acceptable et faisable. De plus, les participants du GE n’ont pas expérimenté une douleur de plus faible intensité mais ils ont rapporté significativement moins d’interférence de la douleur avec la toux et la respiration profonde, ont démontré moins de barrières face à la gestion de la douleur et ont consommé plus d’opiacés. Cette étude pilote procure des résultats prometteurs sur les bénéfices potentiels de cette nouvelle approche sur mesure utilisant les technologies de l’information et de la communication (TIC). L’autonomisation des personnes est cruciale et complémentaire pour soutenir le soulagement de la douleur dans le contexte actuel de soins. / Several studies have shown that many patients undergoing a cardiac surgery suffer from moderate to severe pain. These levels of pain may be explained by individual barriers toward pain relief. Knowledge acquired on pain-related cognitions has not been translated into new approaches. The aim of the doctoral project was 1) to develop an intervention to facilitate the self-management of postoperative pain after cardiac surgery and, 2) to assess its the acceptability and feasibility and to investigate its efficacy potential on pain relief in patients undergoing cardiac surgery. The development of SOULAGE-TAVIE included four steps based on clinical, empirical and theoretical knowledge and inspired by diverse methodological considerations. SOULAGE-TAVIE consists in a 30-minute computer-tailored preoperative educational session about postoperative pain management, tailored according to an algorithm. Two short reinforcements are provided in person. The evaluation of SOULAGE-TAVIE consisted in a pilot randomized controlled trial including 60 participants assigned to the experimental group (EG: SOULAGE-TAVIE) and the control group (CG: usual care including educational pamphlet). Data were collected at the time of admission and across Day 1 to 7 after surgery. The results provide preliminary support for the acceptability and feasibility of a tailored and virtual intervention. The results revealed that patients of the EG did not experience less intense pain but they reported significantly less pain interference when breathing/coughing, exhibited fewer pain-related barriers, and consumed more opioid medication. This pilot study provides promising results to support the potential benefits of this new web-tailored approach. Patient empowerment is complementary yet crucial in the current context of care and may contribute to improve pain relief.

Introduction: Les instillations nasales de solution saline isotonique (INSS) chez les enfants sont recommandées par les pédiatres et des oto-rhino-laryngologistes de notre institution dans le but de prévenir les otites moyennes aigues à répétition (OMAr). Cependant, aucune étude dans la littérature ne vient corroborer ou infirmer cette pratique. Objectifs: Déterminer l’efficacité des INSS dans la prévention des OMAr. Méthode: Projet pilote d’un essai clinique randomisé. Les enfants diagnostiqués avec des OMAr étaient éligibles. Les patients recrutés ont été randomisés en 2 groupes. Seul le groupe traitement procède aux INSS. L’issue primaire est l’incidence d’OMAr pendant une période de 3 mois. Résultats: Vingt-neuf patients satisfaisant les critères d’inclusion et d’exclusion ont consenti à participer. Le taux d’OMAr était inférieur dans le groupe traitement (p=0.03, chi-carré) Conclusion: Les INSS semblent efficaces dans la prévention des OMAr. Une étude multicentrique est indiquée pour vérifier la validité externe et confirmer la sécurité. / Introduction: Normal saline nasal cavity irrigations (NSNI) are commonly recommended by pediatricians and otolaryngologists to prevent recurrent acute otitis media (rAOM). However, no published scientific study corroborates or invalidates this practice. Goal: To determine the efficacy of NSNI to prevent rAOM. Method: Pilot randomized controlled clinical trial. All consecutive patients with a diagnosis of rAOM were eligible. Recruited patients were randomized in 2 groups. Only patients in the treatment group proceeded with NSNI. The primary outcome of the study was the incidence of rAOM observed during a 3 month period. Results: Twenty-nine patients met the inclusion and exclusion criteria and agreed to participate. There was a statistically significant lower incidence of rAOM in the treatment group (p=0.003, Fisher exact). Conclusion: Our results suggest that NSNI could effectively prevent rAOM. A larger scale randomized multicentre study is feasible, and it must be done in order to verify for external validity and to properly assess safety issues.

Objectifs: Observer l’évolution de la stomatite prothétique dans le temps quant à la fréquence et la sévérité ainsi que son association avec de potentiels facteurs de risque au cours d’un suivi longitudinal de 2 ans. Matériels et méthodes : Cent trente-cinq patients âgés complètement édentés et en bonne santé ont été sélectionnés pour participer à cette étude et ont été divisés de façon randomisée en deux groupes. Ils ont tous reçu une prothèse dentaire amovible totale conventionnelle au maxillaire supérieur. La moitié d’entre eux a reçu une prothèse totale mandibulaire implanto-portée retenue par deux attachements boule et l’autre moitié une prothèse conventionnelle. Ils ont été suivis sur une période de deux ans. Les données sociodémographiques, d’habitudes de vie, d’hygiène et de satisfaction des prothèses ont été amassées à l’aide de questionnaires. Les patients ont aussi subi un examen oral complet lors duquel une évaluation de la stomatite prothétique, basée sur la classification de Newton, a été effectuée ainsi qu’un prélèvement de la plaque prothétique. Les analyses microbiologiques pertinentes afin de détecter la présence de Candida ont ensuite été effectuées. Des tests Chi-carré de Pearson et McNemar ont été utilisés pour analyser la fréquence de la stomatite, son association avec de possibles facteurs de risque ainsi que son évolution dans le temps. Des rapports de cotes (odds ratio) et leurs intervalles de confiance (95%) ont été effectués afin de déterminer la force d’association entre les facteurs de risque et la stomatite prothétique. Résultats : La prévalence de la stomatite a augmenté entre la première (63,6%) et la deuxième année de suivi (88,7%) avec une incidence de 78,8%. Les patients souffrant d’une stomatite de type 2 ou 3 et qui brossent leur palais ont environ 6 fois plus de chance de voir la sévérité de leur stomatite diminuer [p = 0,04 OR 5,88 CI (1,1-32,2)]. Il n’y a pas d’association statistiquement significative entre la fréquence de la stomatite et les facteurs de risque investigués. La prévalence de la candidose est demeurée stable dans le temps (45,8% et 49,2% à la première et deuxième année de suivi respectivement, p > 0,05). Il n’y a pas d’association entre la présence d’une candidose orale, la stomatite prothétique et les facteurs de risque étudiés. Conclusion : Les résultats de cette étude suggèrent que la stomatite prothétique progresse dans le temps indépendamment de la présence d’une candidose. Le brossage du palais pourrait être une approche simple à conseiller aux patients souffrant d’une stomatite prothétique de type 2 ou 3. / Objectives: To assess the evolution of denture stomatitis in term of frequency and severity and its association with potential risk factors over a two-year period. Methods: One hundred thirty five healthy edentulous elders who were randomly rehabilitated with a maxillary complete denture opposed by a conventional denture or an implant-supported overdenture retained by two ball attachments were followed over two years. Demographic and clinical data concerning oral and general health, smoking, denture status and hygienic habits were obtained from oral examination and standard questionnaires. Denture stomatitis was evaluated according to Newton’s classification. Microbiological analyses consist of detection of Candida species in denture plaque and inoculation in selective growth medium. Pearson Chi-square and McNemar tests were used to analyse the frequency of denture stomatitis, its association with potential risk factors and it’s evolution over time. Odds ratios and their 95% confidence intervals were calculated to determine the strength of association between risk factors and denture stomatitis. Results: The prevalence of denture stomatitis increased between the first (63.6%) and second year follow-up (88.7%) with an incidence rate of 78.8%. Those individuals suffering from type 2 or type 3 denture stomatitis and who brushed their palate had approximately 6 times more chance of observing a decrease in the severity of their condition [p=0.04 OR 5.88 CI (1.1-32.2)]. There was no statistically significant association between the frequency of denture stomatitis and classical risk factors at both follow-ups. The carriage rate of Candida species remained stable over time (45.8% and 49.2% first and second year of follow-up consecutively, p > 0.05). There was no association between the presence of oral candidiosis and denture stomatitis or its potential risk factors. Conclusion: The results of this study suggest that denture stomatitis progresses overtime independent of Candida carriage. Palatal brushing could be a preventive approach to minimise the inflammation in individuals suffering from type 2 or type 3 denture stomatitis.

Problématique : Les prématurés évoluent dans l’unité néonatale qui présente une intensité lumineuse parfois forte et variable, ce qui a pour effet de provoquer une instabilité physiologique, ainsi qu’une augmentation du niveau d’activité motrice chez ces derniers. Par ailleurs, le contrôle de l’éclairage à l’unité néonatale favorise la stabilité physiologique et réduit le niveau d’activité motrice des prématurés. Deux méthodes de contrôle de l’éclairage ont été étudiées, soit l’éclairage tamisé constant et l’éclairage cyclique. Or, la méthode de contrôle de l’éclairage la plus appropriée au système nerveux immature des prématurés est inconnue et il y a ambivalence en ce qui concerne les résultats des études ayant évalué ces deux modes de contrôle de l’éclairage. But : Le but de cette étude était de mesurer les effets de l’éclairage cyclique versus l’éclairage tamisé constant sur la stabilité physiologique et le niveau d’activité motrice de prématurés nés entre 28 et 32 semaines d’âge gestationnel. Méthode : Un essai clinique randomisé a été réalisé. Les 38 prématurés recrutés dans une unité néonatale de niveaux II et III d’un hôpital universitaire, ont été randomisés dans l’un des deux groupes d’intervention, soit le groupe exposé à l’éclairage tamisé constant ou celui exposé à l’éclairage cyclique. Ces deux types d’éclairage ont été appliqués pendant 24 heures. La stabilité physiologique a été mesurée par le score Stability of the Cardio Respiratory System in Premature Infants (SCRIP) et le niveau d’activité motrice a été mesuré avec un accéléromètre (Actiwatch®). L’intensité lumineuse à laquelle les prématurés ont été exposés a été mesurée de façon continue à l’intérieur de l’incubateur à l’aide d’un photomètre. Résultats : L’analyse des données révèle qu’il n’y aucune différence significative entre les deux groupes d’intervention en ce qui a trait à la stabilité physiologique (valeur-p du score SCRIP de 0,54 à 0,96) et au niveau d’activité motrice (valeur-p de 0,09 à 0,88). Les participants des deux groupes ont manifesté une stabilité physiologique et un niveau d’activité motrice comparables. Conclusion : Des interventions de contrôle de l’éclairage doivent être adoptées à l’unité néonatale, que ce soit des interventions qui permettent la mise en œuvre de l’éclairage cyclique ou de l’éclairage tamisé constant, dans le but de favoriser l’adaptation du prématuré à l’environnement de l’unité néonatale. Des recherches additionnelles sont requises afin d’identifier la méthode de contrôle de l’éclairage (éclairage cyclique ou éclairage tamisé constant) qui doit être implantée à l’unité néonatale. / Problem statement: After birth, preterm infants evolve in the neonatal intensive care unit (NICU) characterized by a high and variable lighting which differs significantly from the dimmed intra-uterine environment. Exposure to high or variable NICU lighting can create physiological instability in preterm infants as well as increasing their motor activity level. An appropriate control of the NICU lighting can prevent the adverse effects of exposing infants to inadequate levels of lighting. To date, it appears that two methods of lighting control have been discussed and studied: near dark lighting and cycled lighting. At the same time, it is acknowledged that there is ambiguity about the results of studies which have evaluated these two NICU lighting methods. Therefore, the optimal NICU lighting remains unknown and further research is needed to identify the lighting mode witch promote preterm infant’s adaptation to the NICU environment. Purpose: The objective of this research was to evaluate the effects of cycled lighting versus near dark lighting on the physiological stability and motor activity level of preterm infants born between 28 and 32 weeks of gestation. Methods: A randomized controlled trial (RCT) allowed the assessment of preterm infants' physiological stability and motor activity level. 38 preterm infants born between 28 to 32 weeks of gestational age were recruited from a level II and III NICU university affiliated hospital. Each infant were randomly allocated to one of the following groups for 24 hours: cycled lighting or near dark lighting. Physiological stability was assessed by the SCRIP score, while the motor activity level was evaluated by an accelerometer (Actiwatch®). The light intensity level was continuously measured with a light meter to ensure that the lighting mode assigned was respected. Results: The analysis conducted indicates no significant difference between the two intervention groups in regard to physiological stability (score SCRIP = p-value 0.54 to 0.96) and the motor activity level (p- value 0.09 to 0.88). This lack of significant difference between the two groups indicates that the participants in the two groups demonstrated a comparable physiological stability state and a comparable level of motor activity when exposed to near dark lighting or cycled lighting. Conclusion: Guidelines to decrease bright light, either near dark or cycled light should be adopted in NICUs to control preterm infant’s’ exposure to light. Further research is required to identify the method of lighting control (cycled lighting or near dark lighting) which should be implanted in the neonatal unit.

<b>Background:</b> Defined by their mechanisms, social and psychological interventions are those interventions that work through mental processes and social phenomena. They are often complex and challenging to evaluate, so understanding randomised controlled trials (RCTs) of these interventions requires detailed reports of the interventions tested and the methods used to assess them. However, reports of these RCTs often omit important information. Poor reporting hinders critical appraisal and synthesis of RCTs in systematic reviews, thereby impeding the effective transfer of research evidence to policy and practice. The Consolidated Standards for Reporting Trials (CONSORT) Statement is a reporting guideline that has contributed to improvements in the quality of RCT manuscripts in journals publishing medical research. However, studies have shown persistent deficiencies in the reporting quality of social and psychological intervention trials. A new CONSORT extension for these interventions may be needed given their distinct and complex features. This DPhil thesis reports on a project to develop and disseminate an official CONSORT Extension for Social and Psychological Interventions: CONSORT-SPI. <b>Structure:</b> Following a preface, this DPhil thesis includes eight chapters. Chapter 1 provides an overview of the conceptual rationale that prompted the CONSORT-SPI project. Chapter 2 details the project protocol, which consists of a five-phase methodology that follows current best practices for reporting guideline development and dissemination. Chapter 3 discusses systematic literature reviews to assess reporting guidelines for and the reporting quality of publications of social and psychological intervention RCTs. Chapter 4 discusses an online, international Delphi process to generate a prioritised list of possible items to include in the CONSORT-SPI extension. Chapter 5 discusses a formal consensus meeting to select reporting items to add to or modify for the CONSORT-SPI Extension checklist. Chapter 6 involves drafts of the CONSORT-SPI checklist as well as a template for the Explanation and Elaboration (E&E) document providing detailed advice and examples of good reporting for each checklist item. These drafts have not yet been circulated to co-authors or other members of the project team; their purpose in this thesis is to give an indication of how previous project phases have led into initial prototypes of the checklist and E&E, which will undergo further development and revision by the project team before publication. Chapter 7 proposes a coordinated dissemination and implementation strategy informed by theoretical frameworks and tools used to guide the implementation of clinical guidelines and empirically-supported interventions. The final chapter summarises the information gained from the CONSORT-SPI project to date, assesses strengths and limitations of the project methodology, and discusses implications for future research. <b>Conclusion:</b> A CONSORT-SPI Extension could improve the reporting quality of social and psychological intervention RCTs. This extension could also facilitate better critical appraisal of this body of research and its use in evidence-based decision-making. With successful dissemination and implementation, the guideline will hopefully contribute to the improvement of intervention evaluations—as well as the methodology underpinning these studies—within the social and behavioural sciences.

INTRODUÇÃO: Pacientes com rigidez pós-traumática do cotovelo que falharam à fisioterapia convencional têm como possibilidades de tratamento protocolos de reabilitação associado ao uso de órtese ou à liberação cirúrgica do cotovelo. Na literatura não existem artigos comparativos entre essas duas formas de tratamento. O objetivo primário deste estudo foi comparar a amplitude de movimento de flexoextensão do cotovelo entre os pacientes submetidos ao tratamento cirúrgico ou à reabilitação. Os objetivos secundários foram comparar os resultados clínicos, de acordo com a escala \"Mayo Elbow Performance Score\", o questionário \"Disability of Arm, Shoulder and Hand\" e a escala visual analógica de dor, além de comparar o ganho absoluto e relativo da flexoextensão, a flexão e extensão máxima, a amplitude de pronossupinação e a taxa de complicações. MÉTODOS: Estudo clínico randomizado, com avaliador cego, de pacientes com rigidez póstraumática do cotovelo que apresentaram falha ao tratamento fisioterápico convencional. Os pacientes foram alocados aleatoriamente em dois grupos de tratamento: conservador e cirúrgico. O grupo conservador foi submetido ao protocolo de reabilitação envolvendo a equipe de terapia ocupacional, com exercícios e alongamentos associados ao uso de órteses estáticas seriadas de extensão, dinâmicas de flexão, além de sessões de movimentação contínua passiva. O grupo cirúrgico foi submetido à liberação cirúrgica por via posterior, seguido do mesmo protocolo de reabilitação do grupo conservador. As escalas clínicas foram aplicadas pré-operatoriamente, aos 3 e 6 meses de seguimento. A amplitude de movimento foi avaliada nos mesmos períodos e adicionalmente com 6 semanas. As complicações foram avaliadas até os 6 meses de tratamento. O desfecho primário do estudo foi a amplitude de movimento de flexoextensão aos 6 meses de seguimento. RESULTADOS: Trinta pacientes foram incluídos no estudo, sendo 15 em cada grupo. A amplitude de movimento de flexoextensão do cotovelo, ao final dos 6 meses de seguimento, foi de 108,4º para o grupo cirúrgico e de 88,1º para o grupo conservador (p=0,002). O ganho absoluto e relativo da flexoextensão do cotovelo aos 6 meses foram respectivamente de 17,2º e 26,8% para o grupo conservador e de 40,8º e 58,8% para o grupo cirúrgico (p < 0,001). A pontuação da escala visual analógica de dor, escala \"Mayo Elbow Performance Score\" e o questionário \"Disability of Arm, Shoulder and Hand\" foram respectivamente de 4,4, 70,6 e 35,3 para o grupo conservador e de 3,9, 77,3 e 27,6 para o grupo cirúrgico (p=0,486, p=0,342 e p=0,361). O grupo conservador apresentou uma complicação, enquanto o grupo cirúrgico quatro (p=0,598). CONCLUSÕES: A liberação cirúrgica do cotovelo associada ao protocolo de reabilitação resultou em uma maior amplitude de flexoextensão, além de um maior ganho absoluto e relativo quando comparada à reabilitação isolada após 6 meses. A extensão máxima obtida foi superior no grupo cirúrgico, sem diferença para a flexão máxima e amplitude de movimento de pronossupinação. Os grupos não diferiram nas escalas funcionais e na taxa de complicações / INTRODUCTION: Patients with post-traumatic elbow stiffness who have failed conventional physiotherapy have two options of treatment: rehabilitation protocols associated with the use of bracing or surgical elbow release. In the literature there are no comparative studies between those forms of treatment. The primary objective of this study was to compare the elbow flexion-extension range of motion between patients submitted to surgical treatment or rehabilitation. The secondary objectives were to compare the clinical outcomes according to the Mayo Elbow Performance Score, the Disability of Arm, Shoulder and Hand questionnaire and the visual analogue pain scale, in addition to comparing the absolute and relative gain of elbow flexion-extension, maximal flexion and extension, pronosupination range of motion and complications rate. METHODS: Randomized clinical trial with blind evaluator of patients with post-traumatic elbow stiffness who presented failure to conventional physiotherapeutic treatment. Patients were randomly assigned to two treatment groups: non surgical and surgical. The non surgical group was submitted to a rehabilitation protocol involving the occupational therapy team, with exercises and stretching associated with the use of serial extension static braces, dynamics braces and continuous passive movement sessions. The surgical group was submitted to surgical release, followed by the same protocol of rehabilitation of the non surgical group. The clinical scales were applied preoperatively, at 3 and 6 months of follow-up. The range of motion was assessed at the same periods and additionally at 6 weeks. Complications were assessed up to 6 months of treatment. The study primary outcome was the flexion-extension range of motion at 6 months of follow-up. RESULTS: Thirty patients were included in the study, 15 in each group. The elbow flexion-extension range of motion at 6 months of follow-up was 108.4º for the surgical group and 88.1º for the non surgical group (p=0.002). The absolute and relative gain of elbow flexion-extension at 6 months were 17.2º and 26.8% for the non surgical group and 40.8º and 58.8% for the surgical group (p < 0.001). The visual analogue pain scale, the Mayo Elbow Performance Score and the Disability of Arm, Shoulder and Hand questionnaire were respectively 4.4, 70.6 and 35.3 for the non surgical group and 3.9, 77.3 and 27.6 for the surgical group (p=0.486, p=0.342 and p=0.361). The non surgical group presented one complication, while the surgical group had four (p=0.598). CONCLUSIONS: The elbow surgical release associated with the rehabilitation protocol resulted in a greater flexion-extension range of motion and greater absolute and relative gain when compared to the isolated rehabilitation after 6 months. The maximal extension obtained was superior in the surgical group, with no difference for maximal flexion and pronosupination range of motion. The groups did not differ on functional scales and complication rates

INTRODUÇÃO: O envelhecimento está associado, muitas vezes, a um declínio cognitivo frequentemente negligenciado, especialmente quando em formas brandas e/ou iniciais, com importante repercussão na vida das pessoas. Tais declínios podem regredir para a normalidade, estabilizar ou mesmo evoluir para quadro demenciais. O comprometimento cognitivo leve (CCL) é uma síndrome clínica de associada a um risco aumentado de demência, podendo ter várias etiologias e patologias. Até o momento, não existe ainda uma abordagem terapêutica, deixando uma lacuna no arsenal terapêutico tanto do especialista quanto do clínico geral. A estimulação magnética transcraniana é uma técnica não invasiva e promissora. Tem potencial para melhorar a memória e a cognição de idosos ativando redes neurais. OBJETIVOS: Este trabalho visa verificar os efeitos da estimulação magnética transcraniana repetitiva (EMTr) de alta frequência primeiramente sobre a memória e, secundariamente, sobre a cognição global de idosos com CCL. MÉTODOS: Trata-se de um estudo duplo cego, randomizado sham-controlado. Foram estimulados 32 idosos com idades entre 60-74 anos, totalmente independentes para as atividades instrumentais de vida diária (AIVDs), com queixas subjetivas de memória e evidência de algum prejuízo na avaliação neuropsicológica, caracterizando CCL. Os participantes foram divididos em dois grupos: (I) EMTr ativa (n=15) e (II) EMTr sham (n=17). O grupo ativo recebeu 10 sessões de EMTr a 10Hz (110% do limiar motor e 2.000 pulsos por sessão) sobre o córtex pré-frontal dorso lateral esquerdo.Foi utilizada uma bobina inativa (sham) para o grupo placebo. As baterias neuropsicológicas foram realizadas nos três tempos: antes (T0), logo após (T1) e um mês após (T2) a EMTr. RESULTADOS: Dos 109 pacientes triados, 36 foram elegíveis para o estudo. Houve 4 desistências, e 32 finalizaram o estudo. Os dados demográficos foram homogêneos. Os escores dos testes foram ajustados para a idade e escolaridade. O ponto de corte do Escore Isquêmico de Hachinski foi <=4. A medida de desfecho primário foi o teste ecológico Rivermead Behavioural Memory (RBMT) devido a sua alta capacidade de predizer problemas de memória diárias. As variáveis contínuas foaram avaliadas pelo teste t de Student. Análise de variância para medidas repetidas (ANOVA) foi utilizada para comparar as medidas de variáveis quantitativas ao longo dos instantes de medição. Houve interação (efeito de grupo) a favor do grupo ativo nas variáveis Rivermead Behavioural Memory Test (p=0,042) e teste de Stroop (retângulos) (p=0,044) em T0-T1; dígitos ordem direta (p=0,041) e trilhas B em T1-T2 (p=0,032). Houve interação no teste de memória lógica tardia em T0-T1 e T0-T2 (p=0,044 e 0,005, respectivamente) a favor do grupo sham; porém, o desfecho foi igual em T2 em ambos os grupos. Não houve interação no IQCODE e na escala de Bayer de funcionalidade. Os resultados mostram melhora significativa, a um nível de 5% de significância, na memória do dia a dia, da atenção e de função executiva dos idosos que se submeteram à EMTr de alta frequência, sugerindo seu potencial terapêutico no CCL. Trial registration: clinicaltrials.gov Identifier: NCT01292382. / BACKGROUND: Aging maybe associated with a cognitive decline often overlooked, especially in milder forms, with significant impact on people\'s lives. Such declines may regress to normal, or even stabilize, or progress to dementia. Mild cognitive impairment (MCI) is a clinical syndrome associated with an increased risk of dementia and may have different etiologies and pathologies. To date, there is still not a therapeutic approach, leaving a gap in the therapeutic armamentarium of both expert as the general practitioner. Transcranial magnetic stimulation is a promising and noninvasive technique with potential to improve memory and cognition in elderly by activating neural networks. OBJECTIVES: This study aims to assess the effects of high frequency repetitive transcranial magnetic stimulation (rTMS) primarily on memory and secondarily on global cognition in elderly people with MCI. METHODS: Double blind, randomized sham-controlled trial. Were stimulated 32 eldrely aged 60-74 years, totally independent for instrumental activities of daily living (IADL) with subjective memory complaints and evidence of some impairment in neuropsychological assessment, characterizing MCI. Subjects were divided into two groups: (I) active rTMS (n=15) and (II) rTMS sham (n=17). The active group received 10 sessions of 10 Hz rTMS (110% of motor threshold and 2000 pulses per session) over left dorsolateral prefrontal cortex. We used a inactive coil (sham) for the placebo group. The neuropsychological assessment were conducted in three stages: before (T0), immediately after (T1) and one month after (T2) rTMS. RESULTS: Of 109 patients screened, 36 were eligible for the study. There were 4 dropouts, and 32 completed the study. Demographic data were homogeneous. The test scores were adjusted for age and education. All subjects presented a cut-off score <=4 for the Hachinski Ischaemic Score. Continuous variables were evaluated by Student t test. Repeated measures of anayses of variance (ANOVA) were used to compare measures of quantitative variables along time. The primary outcome measure was a positive response on the ecological tool Rivermead Behavioural Memory Test (RBMT) because of its capacity to predict everyday memory problems. There was interaction (group effect) in favor of the active group over the variables RBMT (p=0.042) and Stroop test (colored rectangles) (p=0.044) at T0-T1; digit span direct order (p=0.041) and trail making B, T1-T2 (p=0.032). There was interaction in late logic memory test at T0-T1 and T0-T2 (p=0.044 and 0.005, respectively) for the sham group, but the outcome was the same in both groups at T2. There were no significant interaction at IQCODE and Bayer ADL Scale. The results present significant improvement, at a 5% level of significance, in everyday memory, attention and executive function of the elderly who underwent to high-frequency rTMS, suggesting its therapeutic potential in MCI. Trial registration: clinicaltrials.gov Identifier: NCT01292382.