High-frequency spinal cord stimulation as rescue therapy for chronic pain patients with failure of conventional spinal cord stimulation

El objetivo de este estudio es evaluar la eficacia de los dispositivos de alta frecuencia (HF10) de 10 kHz como tratamiento en pacientes con fracaso de la terapia convencional de estimulación medular (EME) para el dolor crónico sin necesidad de cambiar el hardware medular. Métodos. En este estudio prospectivo del mundo real, se incluyeron pacientes con dolor neuropático tratados con EME tónica convencional en los que la terapia había fracasado, ya fuera durante la fase de prueba o tras un periodo óptimo. Resultados. Once de los 18 (61%) pacientes incluidos en el estudio fueron rescatados con éxito con HF10-SCS. De ellos, 5 de 12 (45%) estaban en fase de prueba y 6 de 6 (100%) tenían implantes que funcionaban previamente. Se obtuvo una mejora significativa del dolor lumbar y de las extremidades (p = 0,003 y p = 0,0001, respectivamente). El éxito del tratamiento se asoció significativamente con el sexo (p = 0,037), el peso (p = 0,014), el índice de masa corporal (IMC) (p = 0,007) y el tiempo de rescate (p = 0,015). Una prueba de regresión lineal confirmó una asociación significativa entre el fracaso del tratamiento y el IMC y el sexo (p = 0,004). Conclusiones. Nuestros resultados sugieren que el rescate analgésico con SCS-HF10 es una opción terapéutica eficaz para los pacientes que no responden a la SCS convencional, aunque la obesidad podría ser un factor limitante del éxito del tratamiento. No obstante, se necesitan estudios más exhaustivos para corroborar nuestros hallazgos.This study aims to evaluate the efficacy of 10-kHz high-frequency (HF10) devices as a rescue treatment in patients with failure of conventional spinal cord stimulation (SCS) therapy for chronic pain without the need to change the spinal hardware. Methods. In this real-world prospective study, patients with neuropathic pain treated with conventional tonic SCS in whom the therapy had failed, either during the trial phase or after a period of optimal. Results. Eleven of the 18 (61%) patients included in the study were successfully rescued with HF10-SCS. Of them, 5 out of 12 (45%) were in the trial phase and 6 out of 6 (100%) had previously functioning implants. A significant improvement in low-back and limb pain was obtained (p = .003 and p = .0001, respectively). Treatment success was significantly associated with gender (p = .037), weight (p = .014), body mass index (BMI) (p = .007) and time of rescue (p = .015). A linear regression test confirmed a significant association between treatment failure and BMI and gender (p = .004). Conclusions.Our results suggest that analgesic rescue with HF10-SCS is an effective therapeutic option for nonresponders to conventional SCS, although obesity might be a limiting factor for treatment success. Nevertheless, more comprehensive studies are needed to corroborate our findings

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy:Study protocol of a cluster randomized clinical trial (Multi-PAP project)

This study was funded by the Fondo de Investigaciones Sanitarias ISCIII (Grant Numbers PI15/00276, PI15/00572, PI15/00996), REDISSEC (Project Numbers RD12/0001/0012, RD16/0001/0005), and the European Regional Development Fund ("A way to build Europe").Background: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12months, as compared with usual care. Methods/Design: Design:pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. Scope: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). Population: patients aged 65-74years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3months). Sample size: n=400 (200 per study arm). Intervention: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. Outcomes: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. Statistical analysis: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. Discussion: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. Trial registration: Clinicaltrials.gov, NCT02866799Publisher PDFPeer reviewe

Effectiveness of Pregabalin as Monotherapy or Combination Therapy for Neuropathic Pain in Patients Unresponsive to Previous Treatments in a Spanish Primary Care Setting

Journal Article; Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.BACKGROUND AND OBJECTIVE Patients from a previous study of neuropathic pain (NP) in the Spanish primary care setting still had symptoms despite treatment. Subsequently, patients were treated as prescribed by their physician and followed up for 3 months. Since pregabalin has been shown to be effective in NP, including refractory cases, the objective of this study was to assess the effectiveness of pregabalin therapy in patients with NP refractory to previous treatments. METHODS This was a post hoc analysis of pregabalin-naïve NP patients treated with pregabalin in a 3-month follow-up observational multicenter study to assess symptoms and satisfaction with treatment. Patients were evaluated with the Douleur Neuropathique en 4 questions (DN4), the Brief Pain Inventory (BPI) and the Treatment Satisfaction for Medication Questionnaire (SATMED-Q) overall satisfaction domain. RESULTS 1,670 patients (mean age 58 years, 59 % women), previously untreated or treated with ≥1 drug other than pregabalin, were treated with pregabalin (37 % on monotherapy). At 3 months, pain intensity and its interference with activities decreased by half (p < 0.0001), while the number of days with no or mild pain increased by a mean of 4.5 days (p < 0.0001). Treatment satisfaction increased twofold (p < 0.0001). Patients with a shorter history of pain and those with neuralgia and peripheral nerve compression syndrome (PCS) as etiologies had the highest proportion on monotherapy and showed the greatest improvements in pain-related parameters in their respective group categories. CONCLUSION Treatment with pregabalin (as monotherapy or combination therapy) provides benefits in pain and treatment satisfaction in patients with NP, including refractory cases. Shorter disease progression and neuralgia and PCS etiologies are favorable factors for pregabalin treatment response.This study was sponsored by Pfizer SLU, Madrid, Spain.Ye

Analgesic efficacy of tramadol/dexketoprofen vs Ibuprofen after impacted lower third molar extraction: a randomized controlled clinical trial

Objective Impacted third molar extraction is associated with acute moderate-to-severe pain for up to 48 hours post-surgery. This trial was designed to compare the analgesic effectiveness, swelling, and adverse events after impacted third molar surgery following multimodal therapy with 75 mg tramadol hydrochloride plus 25 mg dexketoprofen or monotherapy with 400 mg ibuprofen. Methods Seventy-two patients were randomly assigned to receiving ibuprofen (n = 36) or tramadol-dexketoprofen (n = 36). Postoperative pain intensity and swelling were measured using a visual analog scale (VAS); pain relief experienced was reported using a 4-point verbal rating scale; the rescue medication requirement, adverse effects, and global impression of the medication were recorded. Results No statistically significant between-group difference in pain intensity was observed at any time point; however, pain relief was significantly higher in the tramadol-dexketoprofen treated-group at 6 and 36 hours. Self-reported verbal rating scale assessments showed significantly lower swelling in the tramadoldexketoprofen group at 24 hours post-surgery but not at 48 or 72 hours, and VAS- swelling scores showed no significant between-group difference. The frequency of postoperative nausea and dizziness was significantly higher in the tramadoldexketoprofen group. Conclusions Multimodal therapy proved more effective to manage moderate-severe pain after impacted third molar surgery in comparison to monotherapy. However, the improvement in relief must be balanced against the increased risk of adverse effects when considering this multimodal approach

Avulsión del plexo braquial traumático no controlado con remifentalino: Papel de la analgesia epidural cervical

Presentamos el caso de una paciente que sufrió accidente de tráfico con avulsión del plexo braquial izquierdo, y que presentaba dolor muy intenso (escala visual analógica 8) de características neuropáticas en la fase aguda postraumática. Dosis altas de remifentanilo fueron inefectivas para control del cuadro álgico, el cual se trato con éxito con una infusión de ropivacaína a través de catéter epidural cervical (C5-6). El dolor es controlado en fase crónica (escala visual analógica 2) con agentes específicos contra dolor neuropático (gabapentina, amitriptilina, clonacepam y tramadol).We presented you a patient who suffered a left brachial plexus avulsión with hard neuropatic pain in the posttraumatic acute phase (visual analogue scale 8). High-dose remifentanil infusión was uneffective in controlling pain, which was further ameliorated by ropivacaine infused through a cervical (C5-6) epidural catheter. At discharge pain remained controlled (visual analogue scale 2) with specific treatment against neuropathic pain (gabapentin, amytriptiline, clonacepam, and tramadol)

Estudio CRONO: prevalencia del dolor irruptivo en pacientes con dolor crónico no oncológico en Andalucía, España

ABSTRACT Objective: The aim of this study was to evaluate the prevalence of breakthrough pain (BTP) in ambulatory patients with non-cancer chronic pain in Spain and to characterize physiopathology, location, intensity and frequency of BTP episodes. Methods: Prospective, non-interventional, observational study conducted in 16 pain units of hospitals of Andalusia and Ceuta. Eligible consecutive patients were are asked if they experience BTP defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite stable and controlled background pain". At each survey day, the first two patients reporting BTP were further interrogated on the clinical characteristics of their BTP (etiology, onset, intensity, frequency and treatment). Results: A total of 3,209 patients with non-cancer chronic pain were screened to identify 1,118 patients with BTP, which represented a prevalence of 36 %. BTP characteristics were retrieved from 350 patients: mean BTP intensity was 8.3 (± 1.4) on a Visual Analogue Scale (VAS), with a mean of 2 episodes/24 hour (range 1-5/24 h). Pain mechanism was mixed in 149 (42.6 %), neuropathic in 91 (26 %) and nociceptive in 72 in (20.6 %) of patients. Significant correlation was found between BTP intensity and both higher background pain (r = 0.243, p < 0.001), and daily BTP episodes frequency (r = 0.123, p = 0.003). 78 % of the patients were on opioid treatment. The most frequent were fentanyl citrate (52.6 %) and tramadol (17.4 %). Conclusions: The prevalence rate of BTP in patients with chronic non-oncologic pain is higher than one-third of the patients seen in outpatient hospital pain units in Spain. BTP causes reduced levels of functionality, psychological disorders, and an increase in health care expenditure. Individualization is the key to treatment.RESUMEN Objetivo: El objetivo de este estudio es evaluar la prevalencia de dolor irruptivo (DI) en pacientes ambulatorios con dolor crónico de origen no oncológico y caracterizar la fisiopatología, localización, intensidad y frecuencia de los episodios de DI. Material y métodos: Estudio observacional, prospectivo y no intervencionista realizado en 16 unidades de dolor ambulatorias de hospitales de Andalucía y Ceuta. Se preguntó a los pacientes consecutivos elegibles si experimentan DI definido como "una exacerbación transitoria del dolor que ocurre espontáneamente, o en relación con un desencadenante predecible o impredecible específico, a pesar del dolor de base estable y controlado". En cada día de la encuesta, los dos primeros pacientes que confirmaron DI fueron preguntados sobre las características clínicas de su PTP (etiología, inicio, intensidad, frecuencia y tratamiento). Resultados: Se realizó un cribaje a un total de 3209 pacientes con dolor crónico no oncológico para identificar a 1118 pacientes con DI, lo que representó una prevalencia del 36 %. Se obtuvieron las características del DI de 350 pacientes: la intensidad media fue de 8,3 (± 1,4) en una Escala Analógica Visual (EVA), con una media de 2 episodios/24 horas (rango 1-5/24 h). El mecanismo del dolor fue mixto en 149 (42,6 %), neuropático en 91 (26 %) y nociceptivo en 72 (20,6 %) de los pacientes. Se encontró correlación positiva entre una mayor intensidad de DI con el nivel de dolor basal (r = 0,243, p < 0,001), y el número de crisis diarias de DI (r = 0,123, p = 0,003), ambas estadísticamente significativas. El 78 % de los pacientes estaba en tratamiento con opioides. Los más frecuentes fueron el citrato de fentanilo (52,6 %) y el tramadol (17,4 %). Conclusiones: La tasa de prevalencia del DI en pacientes con dolor crónico no oncológico es superior a un tercio de los pacientes atendidos en las unidades ambulatorias de dolor hospitalario en España. El DI provoca niveles reducidos de funcionalidad, trastornos psicológicos y un aumento del gasto asistencial. La clave del tratamiento es la individualización