Clinical Trial EuroPainClinics® Examines Benefits of Epiduroscopy
25. 1. 2017
The knowledge platform EuroPainClinics® applied in the medical practice is a cornerstone of development and research activities that EuroPainClinics® pursues at partnership sites by means of clinical studies. EuroPainClinics® Study II, is one of five currently registered trials and examines the benefits of a treatment method called epiduroscopy.
EuroPainClinics® Study II examines the benefit ofepiduroscopy in patients with back pain who have undergone one or more spine surgery procedures resulting in so-called failed back surgery syndrome, FBSS. The study focuses on follow-up visits with patients to determine long-term pain relief and improvement of quality of life of these patients. Its design is a multi-centric, double-blind, randomized study comparing two methodological management procedures. In one patient group, the epiduroscopy was conducted using the method of mechanical lysis (removal) of fibrous adhesions. In the second group, the drug (corticoid) was administered together with the mechanical lysis of the adhesions with the intention to study the effect of the medicinal product that has not yet been confirmed by any clinical trial.
EPCS II study globally and objectively looks at the concrete parameters such as the clinical condition of patients, the stage of pain at so-called Visual Analog Scale for Pain (VAS) and the rate of drug use and quality of life of patients according to the Oswestry Questionnaire. Follow-up of patients is done three times (one examination before the procedure and two examinations after it with the intervals of six and twelve months). EuroPainClinics® is preparing the results of the statistical analysis of the EPCS study for publication in May 2017.
Exhibit: diagram of the EPCS II study, source: EuroPainClinics®
The EuroPainClinics® clinical trials are conducted anonymously. They systematically gather and analyze data on patients undergoing the examined procedures. Their aim is to compare data with other intervention sites as well as contribute scientific knowledge for the improvement of treatment procedures and their introduction into the practice within evidence-based medicine (EBM). The studies are registered in the international registration data basis ClinicalTrials.gov PRS, U.S. National Institutes of Health.