ABSTRACT
BACKGROUND AND OBJECTIVE: Despite its prevalence and impact, breakthrough pain (BTP) in chronic non-cancer pain with neuropathic component, has not been well studied and is sometimes unrecognized and often undertreated. We evaluated the efficacy of sublingual fentanyl tablet (SLF) for the treatment of BTP in opioid-tolerant patients with chronic musculoskeletal pain with neuropathic component in terms of relief of pain intensity and assessed whether hypothetical pain relief impacts on quality of life (QoL). METHODS: A multicenter, prospective, open-label study was conducted over a 30-day period. Efficacy was evaluated using a visual analogue scale (VAS) and time to onset of action of SLF. The incidence of dependence was assessed by the Leeds Dependence Questionnaire (LDQ). Changes in QoL were evaluated using the Brief Pain Questionnaire (BPI) and the EuroQol (EQ-5D). Adverse events (AE) were recorded throughout. RESULTS: 106 patients were enrolled and 105 completed the study. The average pain reduction across the study was -3.30 points [95 % confidence interval (CI) 2.9-3.7; P < 0.0001]. Pain intensity improvement from baseline was statistically significant at first assessment and all subsequent assessments (P < 0.0001). The most common AEs included nausea (33.87 %), constipation (33.06 %), somnolence (19.35 %) and vomiting (6.45 %). No significant differences were observed on LDQ (P = 0.71). QoL as measured by BPI showed statistically significant improvement in all four severity items and all interference items (P < 0.0001) and a significant improvement in the percentage of pain relief reported by patients (P < 0.0001). EQ-5D results showed a trend towards improvement. Mean self-rate health status, as measured by the EQ VAS scale increased significantly (P < 0.0001). CONCLUSION: SLF provides significant reductions in BTP intensity. The results of the BPI and EQ-5D assessments indicate that pain relief is associated with improvement of functioning and enhancement of QoL.
Subject(s)
Breakthrough Pain/drug therapy , Fentanyl/therapeutic use , Musculoskeletal Pain/drug therapy , Neuralgia/drug therapy , Administration, Sublingual , Adult , Aged , Aged, 80 and over , Drug-Related Side Effects and Adverse Reactions , Female , Fentanyl/administration & dosage , Fentanyl/adverse effects , Humans , Male , Middle Aged , Prospective Studies , TabletsABSTRACT
Las técnicas de neuromodulación suponen un abordaje no destructivo y reversible en el tratamiento del dolor. Su utilización se establece como estrategia de control del dolor no controlable dentro de las directrices de la O.M.S. y como alternativa a otras terapias invasivas menores o neuroablatibas que no han sido eficaces o que están contraindicadas. De entre ellas el uso clínico de la estimulación eléctrica medular (EEM) o neuroestimulación, demuestra día a día su utilidad y eficacia en el tratamiento de diferentes síndromes de dolor crónico. Estudios de Cook y cols en 1.976, ya demostraron en sus trabajos la efectividad de esta técnica en la manifestación clínica del dolor isquémico así como en la arterioesclerosis o vasculopatía diabética, o en el dolor isquémico producido por vaso espasmo periférico, en entidades específicas como la Enfermedad de Buerguer, Esclerodermia o Síndrome de Raynaud. Durante la última década, se ha extendido la utilización de la EEM en la cardiopatía isquémica de carácter intratable (angina de pecho refractaria a tratamientos, síndrome X,...) y la patología vascular periférica, objeto de esta revisión. Esta técnica se presenta como una de las principales indicaciones con altos niveles de efectividad (80%), tanto en el aspecto clínico por el alivio sintomático que produce, como en los beneficios isquémicos fisiopatológicos que induce la neuroestimulación (AU)
The Neuromodulation technologies are a not destructive and reversible approach in the treatment of the pain. They are used as a strategy for the control of untreatable pain according to the directives of the OMS and as an alternative of other invasive minor or neuroablatives therapies that have been not effective or that are not indicated. Between them the clinical use of spinal cord stimulation (SCS) has demonstrated its usefulness and efficiency in the treatment of different syndromes of chronic pain. Cook´s and cols. in 1.976, demonstrated in their reports the efficiency of this technique in the clinical manifestation of ischemic pain as well as in the arteriosclerosis, diabetic vasculopaty, or in the ischemic pain related with peripheral vasospasm, in specific pathologies as the Buerguer´s disease, Scleroderma or Raynaud´s syndrome. During the last decade, the utilization of the SCS has spread in the ischemic cardiopathy of untreatable character (refractory angina pectoris, syndrome X, ) and vascular peripheral pathology, subject of this review. This technique appears as one of the main indications with high levels of efficiency (80%), so much in the clinical aspect for the symptomatic relief as well as in the ischemic physiopatologic benefits that induces the neuroestimulation (AU)
