Treatment of headache disorders with acupuncture: a 6-year retrospective study.

OBJECTIVE: Existing systematic reviews and meta-analyses indicate that acupuncture has similar clinical effectiveness in the prevention of headache disorders (HDs) as drug therapy, but with fewer side effects. As such, examining acupuncture's use in a pragmatic, real-world setting would be valuable. The purpose of this study was to compare the effects of acupuncture and prophylactic drug treatment (PDT) on headache frequency in patients with HDs, under real-world clinical conditions. METHODS: Retrospective cohort study of patients with HDs referred to a pain clinic, using electronic health record data. Patients continued with tertiary care (treatment of acute headache attacks and lifestyle, meditation, exercise and dietary instructions) with PDT, or received 12 sessions of acupuncture over 3 months, instead of PDT under conditions of tertiary care. The primary outcome data were the number of days with headache per month, and groups were compared at baseline and at the end of the third month of treatment. RESULTS: Data were analysed for 482 patients with HDs. The number of headache days per month decreased by 3.7 (standard deviation (SD) = 2.9) days in the acupuncture group versus 2.9 (SD = 2.3) in the PDT group (p = 0.007). The proportion of responders was 39.5% versus 16.3% (p < 0.001). The number needed to treat was 4 (95% confidence interval = 3-7). CONCLUSION: Our study has shown that patients with HDs in tertiary care who opted for treatment with acupuncture appeared to receive similar clinical benefits to those that chose PDT, suggesting these treatments may be similarly effective of the prevention of headache in a real-world clinical setting.

Study protocol for a randomised controlled trial of ultrasound-guided pulsed radiofrequency of the genicular nerves in the treatment of patients with osteoarthritis knee pain.

INTRODUCTION: The goals for the management of patients with osteoarthritis (OA) of the knee are to control pain and to minimise disability. Because the number of patients will increase as the population ages, alternative approaches to alleviate their joint pain other than conventional treatments are necessary. The purpose of this article is to present a refined protocol to determine if there is long-term improvement in pain and function after ultrasound-guided pulsed radiofrequency treatment of the genicular nerves (GNs) in patients with chronic painful knee OA. METHODS AND ANALYSIS: This study is a randomised, double-blind, placebo-controlled, parallel design trial. One hundred and forty-two outpatients with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: ultrasound-guided sham GN pulsed radiofrequency without active treatment and ultrasound-guided real GN pulsed radiofrequency. The primary outcome measures will be the observed changes from baseline pain intensity based on visual analogue scale (VAS). The possible changes in the secondary efficacy variables from the baseline as assessed by the Goldberg Anxiety and Depression Scale, pain medication use, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC subscales) and VAS pain intensity are also to be included in the study. These variables will be assessed at baseline, 1 month, 3 months, 6 months and 1 year after treatment. ETHICS AND DISSEMINATION: The protocol was approved by the Research Ethic Committee of the Balearic Islands (IB 3223/16 PI). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION: Trial registration numberNCT02915120; Pre-results.

Electro-acupuncture for treatment of knee pain from osteoarthritis and the possible endocrinology changes: a study protocol for a randomized controlled trial.

BACKGROUND: Osteoarthritis of the knee is a major cause of disability among adults. Electro-acupuncture is considered a potentially useful treatment for osteoarthritis. The purpose of this study is to assess the efficacy of electro-acupuncture on pain control, pain perception, plasma cortisol and beta-endorphin levels, patient-perceived quality of life, and pain medication use in patients with chronic knee pain. METHODS/DESIGN: This study is a placebo-controlled, randomized, double-blind, parallel design trial. One hundred sixty out-patients who are more than 50 years old and who have osteoarthritis of the knee will be recruited from the island of Mallorca, Spain. Each participant will be randomly placed into one of two groups: (sham) electro-acupuncture non-insertion technique and real electro-acupuncture. Acupuncture treatments will be the Traditional Chinese Medicine type. The patients will be evaluated after a period of 1 month (with two weekly sessions), 3 months (with one monthly session), 6 months (with one session every 45 days), and 1 year later with follow-up sessions at the end of the study (with one session every 2 months). The primary outcomes will be based on the observed changes from the baseline of the visual analogue scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain measured at 12 weeks after the end of treatment. Also to be included in the study are the possible changes in the secondary efficacy variables from baseline as assessed by the Short Form 36 version 2 health survey (patient-perceived quality of life), patient plasma cortisol and beta-endorphin levels at the different treatment stages, the Goldberg Anxiety and Depression Scale, pain medication use, functional capacity and stiffness (WOMAC subscales), and a VAS. These variables will be assessed at 1 month, 3 months, 6 months, and 1 year after study commencement. DISCUSSION: The findings from this study will help to determine whether electro-acupuncture is effective for chronic knee pain management in older people and whether electro-acupuncture can deliver results for the improvement of pain relief, stiffness, and disability. The study will therefore be a major step toward understanding the roles of the hypothalamic-pituitary-adrenal axis and the endogenous opioid system in the effectiveness of electro-acupuncture for chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02299713 (11 Nov. 2014).

Sistema de gestión de incidentes críticos y eventos adversos en los ámbitos área, servicio o unidad hospitalarios. Puesta en marcha en tres fases / System for management of critical incidents and adverse events at an anesthesitics area/ department/unit level switch on in three phases

Introducción: Presentamos un modelo de gestión de riesgo basado en avances tecnológicos y organizativos de probada eficacia. Diseñado para una unidad hospitalaria, el modelo es abierto para otros sistemas de comunicación y otras unidades de este u otro hospital. Material y método: El modelo tiene tres fases de implantación. La primera fase incluye el estudio basal de la gestión de seguridad del paciente y medición objetiva de la cultura de seguridad. La segunda fase contiene el diseño y la puesta en marcha del sistema de manejo del incidente crítico, con creación de grupo de expertos internos. La tercera fase implica la integración horizontal y vertical, la formación interna y externa y la apertura del sistema a otras unidades. Resultados: Encontramos un modelo de gestión del riesgo no estructurado, no confidencial, potencialmente punitivo y sin criterios de eficacia. El nivel de cultura de seguridad fue insatisfactorio en todos sus puntos de evaluación. La introducción del sistema de manejo del incidente crítico puso las bases de optimización y evaluación de los procesos relacionados con la seguridad del paciente. Conclusiones: Nuestro sistema de gestión del riesgo es un ejemplo simple, práctico y eficaz de introducción de la estrategia de seguridad del paciente en una unidad hospitalaria (AU)

Introduction: The purpose of this article is to present a model for clinical risk management based on technological and organisational advances with proven effect. Designed for a single clinical Unit, the model is open to other notification systems and health care clinical units. Material and method: The model has three implementation phases. The first phase involved studying the existing safety system and objectively measured the culture of patient safety. The second phase included development and implementation of a system for the management of critical incidents with creation of a team of specialists. The third phase was the development of the technological and organizational base for horizontal and vertical integration, for internal and external training, and opening the system to other clinical units. Results: We found an unstructured, non-confidential, potentially punitive model of clinical risk management without efficacy criteria. There was an unsatisfactory safety culture level for all of the evaluation issues. The introduction of a system for critical incident management gave the basis for the optimization and evaluation of the patient safety related processes. Conclusions: Our model for clinical risk management is a simple, useful and efficient example for introducing a patient safety strategy in a hospital clinical unit (AU)

[Not Available]. / Sistema de gestión de incidentes críticos y eventos adversos en los ámbitos área, servicio o unidad hospitalarios. Puesta en marcha en tres fases.

INTRODUCTION: The purpose of this article is to present a model for clinical risk management based on technological and organisational advances with proven effect. Designed for a single clinical Unit, the model is open to other notification systems and health care clinical units. MATERIAL AND METHOD: The model has three implementation phases. The first phase involved studying the existing safety system and objectively measured the culture of patient safety. The second phase included development and implementation of a system for the management of critical incidents with creation of a team of specialists. The third phase was the development of the technological and organizational base for horizontal and vertical integration, for internal and external training, and opening the system to other clinical units. RESULTS: We found an unstructured, non-confidential, potentially punitive model of clinical risk management without efficacy criteria. There was an unsatisfactory safety culture level for all of the evaluation issues. The introduction of a system for critical incident management gave the basis for the optimization and evaluation of the patient safety related processes. CONCLUSIONS: Our model for clinical risk management is a simple, useful and efficient example for introducing a patient safety strategy in a hospital clinical unit.