EuroPainClinics® Study III
The aim of EPC Study III is to objectify the benefits of the minimally invasive pain management technique, Disc FX, in patients with vertebrogenic algic syndrome and to quantify long-term pain relief and improvement of the quality of life of patients after the procedure. This intervertebral procedure is performed on a select group of patients, upon compliance with indicated study criteria.
The study was approved on April 23rd 2015 by a regional hospital ethics committee under the reference number EK: 9N-2015. It was subsequently registered in the U.S. National Institutes of Health international database https://clinicaltrials.gov PRS: NCT02461654
EPCS 3 Approval document The project meets all the attributes and valid legislative standards relating to medical procedures as approved by the Ministry of Health of the Slovak Republic and the Czech Republic.
EuroPainClinics® Study III (EPCS III) focuses on the clinical research of the Disc FX treatment method.
Disc FX: Indication Criteria
Disc FX is an innovative system allowing safe and efficient access to the affected intervertebral disc without damaging surrounding structures. This method provides an opportunity for treatment to those for whom conventional treatment has been unsuccessful and who are not yet ready for a complex surgery. It is a minimally invasive outpatient procedure, and is divided into three phases. In the first phase, the disc in punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerated inner tissue. Then, using a radiofrequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radiofrequency ablation.
EuroPainClinics® Study III is focused on pursuing long-term pain relief and improved quality of life for selected groups of patients who have undergone the Disc FX procedure, upon compliance with indicated criteria.
Topic of EPC Study III and Registration
The topic of the project is the implementation of a multicenter prospective observational study, observing the development of patients’ clinical conditions at three time points, namely: before the procedure, 6 months after the procedure, and 12 months after the procedure.
The study was prepared and elaborated by EuroPainClinics R.I. It was approved on April 23rd 2015 by the regional hospital ethics committee (reference number: EK: 9N-2015), following the design of the study and preparation of informed consent for study participants, as well as the study protocol. It was subsequently registered in the U.S. National Institutes of Health international database https://clinicaltrials.gov PRS: NCT02461654.
The project meets all aspects and valid legislative standards relating to medical procedures approved by the Ministry of Health of the Slovak Republic and the Czech Republic. The processing of personal data of patients in order to conduct the study is in accordance with the current version of the 2008 Helsinki Declaration and in accordance with the applicable laws of the country. Patient privacy will be guaranteed. The data will be handled in accordance with EU directives: Directive 95/46/EC, Directive 2002/58/EC, Directive 2006/24/EC. It will be ensured that the study protocol, informed consents, and the inclusion in the ongoing study, are provided to the appropriate independent ethics committee in accordance with local requirements. In the event that the laws of the country require so, EuroPainClinics R.I. is responsible for providing annual updates of the documentation to an independent ethics committee. Results obtained in the study will be published in international scientific journals and taken into account in the recommendations and practices of clinical interventional pain management.
Objectives of EPC Study III and Outcome Measures
The aim of EPC Study III is to objectify the benefits of minimally invasive pain management techniques in patients with vertebrogenic pain syndrome and to quantify long-term pain relief and improvement of the quality of life of patients after the Disc FX procedure. The results will be compared with results from other pain management departments in the world. The outcome measures will be the clinical condition, visual pain scale (VAS), global pain scores, spreading of pain in the corresponding dermatomes, reduction in the use of analgesics, and the Oswestry Disability Index (ODI – indicating the quality of life in patients with lumbosacral spine pain). The observed parameters will be recorded in three time periods, namely: before the procedure (First Examination), followed by 6 months after the procedure (Second Examination), and finally 12 months after the procedure (Third Examination). The results will then be subjected to statistical analysis. A further aim of the project is the publication of its findings in international scientific journals.