The objective of the EPCS II study is a comparison of the clinical status of patients who have undergone an epiduroscopic procedure after fulfilling the inclusion criteria.
EUROPAINCLINICS® Study II (EPCS II) objectifies the benefits of the minimally invasive interventional pain management procedure – epiduroscopy, in patients with back pain after one or more failed spine operations with FAILED BACK SURGERY syndrome (FBSS). It is aimed at tracking long-term pain relief and improving the quality of life in these patients. On 23 Apr 2015, the study was approved by the Regional Hospital Ethics Commission under the EC Number: 75 / EC / 15. It was subsequently registered in the National Health Service USA International Database. https://clinicaltrials.gov PRS: NCT02459392. EPCS 2 Approval Document Project meets all attributes and valid legislative standards regarding medical output approved by the Ministries of Health in the Slovak Republic and the Czech Republic.
Study detail
EuroPainClinics®Study II (EPCS II) objectifies the benefits of the minimally invasive interventional pain management procedure – epiduroscopy.
Epiduroscopy – indication criteria
The EuroPainClinics®Study II (EPCS II) study objectifies the benefits of the minimally invasive interventional pain management procedure – epiduroscopy, in patients with back pain who have undergone one or more unsuccessful spinal surgeries and suffer from failed back surgery syndrome – FBSS. The study aims to monitor long-term pain relief and to improve the quality of life of these patients.
Subject of the EPCS II study and registration
The subject of the project is the realization of a multicenter double-blind randomized clinical study assessing the comparison of two methodological procedures for performing epiduroscopic surgery in patients with FBSS.
The study was prepared by Europainclinics. After the elaboration of the study design, preparation of informed consents for its participants and preparation of the protocol, the study was approved by the Regional Hospital Ethics Committee under the EC number: 75 / EK / 15 on 23 April 2015. It was subsequently registered in the international database National Health Service USA https: // clinicaltrials .gov PRS: NCT02459392.
The project meets all the attributes and valid legislative standards related to medical performance approved by the Ministries of Health in the Slovak Republic and the Czech Republic. The processing of patients’ personal data for the purpose of conducting the study is in accordance with the current version of the 2008 Helsinki Declaration and in accordance with the relevant laws of the country. The protection of the patient’s personal data will be maintained. The data will be handled according to EU directives: Directive 95/46 / EC, Directive 2002/58 / EC, Directive 2006/24 / EC. It will be ensured that the study protocol, informed consents to the intervention, and the ongoing study are provided to the appropriate independent ethics committee according to local requirements. If required by the laws of the country, EuroPainClinics is responsible for providing the annual documentation update to an independent ethics committee. The results obtained in the study will be published in professional international journals and taken into account in the recommendations and procedures in the clinical practice of interventional pain management.
The course of the EPCS II study
The aim of the study will be to compare two groups of patients who will undergo an epiduroscopic surgery. In group A patients – only mechanical lysis of fibrous adhesions will be performed during epiduroscopy. In group B patients, mechanical lysis of adhesions and administration of corticoid drugs – depomedrol and hyase – are performed simultaneously. During adhesiolysis, the physician under visual guidance removes the adhesions, which are attached to the affected nerve or dura. They can be removed mechanically – by tearing them off with the tip of a visually guided epiduroscope, or by using pressure while rinsing the area with saline. Advanced methods of mechanical adhesion removal include laser lysis and pulsed radiofrequency ablation. Topically administered drugs to the epidural space during the procedure and their expected effect: Hyase may be involved in the disruption of adhesions by the mechanism of enzymatic cleavage. Depomedrol is expected to have an anti-inflammatory effect at the site of administration and a consequent tendency to reduce the inflammatory response, cell migration, swelling, pain and adhesions. Despite these theoretical assumptions about the effect of administered drugs, the benefit has not yet been verified in the results of published studies, and, therefore, the administration of these drugs is considered debatable.
Objectives of the EPC II study and monitored parameters.
The aim of the project is to compare the clinical condition of patients who underwent epiduroscopic surgery after meeting the inclusion criteria and were included in the EPCS II study. From the monitored parameters, the clinical condition, visual pain scale, Global pain score, spread of pain in the respective dermatomes, reduction of analgesic consumption, Oswestry disability questionnaire (indicating quality of life in patients with lumbosacral spine pain) will be compared. The monitored parameters will be recorded in three time periods: before the procedure (First examination), 6 months after the operation (Second examination) and finally 12 months after the operation (Third examination). The results will then be subjected to statistical analysis. Another goal of the project is to publish the results in professional international journals.
