EuroPainClinics® Study I
The aim of the EPC I project is to compare the clinical status of patients who have undergone periradicular (PRT) procedure, upon compliance with indicated study criteria.
This study focuses on the clinical research of the Periradicular Therapy (PRT) treatment method to treat root syndromes caused by nerve root compression as a result of various pathological processes. Most often these patients have a herniated intervertebral disc as diagnosed using CT or MRI imaging. The study is focused on pursuing long-term pain relief and improving the quality of life in patients undergoing PRT.
EPC Study I was approved on April 23rd 2015 by a regional hospital ethics committee under the number: EK: 74/EK/15. It was subsequently registered in the U.S. National Institutes of Health international database
https://clinicaltrials.gov PRS: NCT02464553.
EPCS 1 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 I (EPCS I) is focused on the clinical research of Periradicular Therapy (PRT) pain treatment methods.
PRT Therapy: Indication Criteria
PRT therapy is directed at the treatment of radicular syndromes caused by compression of nerve roots in the spinal canal as a result of various pathological processes. Such conditions may include foraminal stenosis (the narrowing of the spinal canal), postoperative fibrosis in the epidural space, and other conditions. PRT is one of the treatment possibilities in which anti-inflammatory drugs can be injected together with a local anaesthetic close to the nerve root.
Patients who often benefit from PRT are those with herniated intervertebral discs as diagnosed on CT or MRI imaging. If the pain of a patient diagnosed with radicular syndrome persists for more than three months, despite medical treatment and physiotherapy, PRT is a good indicated option. Its aim is to relieve pain and the inflammatory symptoms at the nerve root area.
It is important to note that PRT may not be indicated for every condition which causes spinal root compression. Examples of contraindications are free fragment, malignant disease, severe acute or chronic inflammatory disorders, coagulation, and others.
Topic of EPC Study I and Registration
EPC Study I is focused on pursuing long-term pain relief and improving the quality of life in patients whose conditions are indicated to undergo Periradicular Therapy.
The topic of the project is the implementation of a multicenter double-blind randomized clinical trial comparing two methodologies of performing Periradicular Therapy. 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: 74/EK/15), 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: NCT02464553.
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 patient data 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 is 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.
Course of EPC Study I
The aim of the study is to compare two groups of patients with pathological findings in the lumbosacral area, for whom Periradicular Therapy is indicated. The condition for enrolment of a patient in the study is an MRI finding of compression in one spinal area, and the symptomatology must correspond to a dermatome situated one level below the lesion.
Patients meeting the criteria for inclusion in the study will be informed by the attending physician about the study and will be offered the opportunity to participate. If the patient agrees, they will be informed about the PRT interventional procedure and asked to sign the informed consent for study participation and informed consent to the invasive procedure, PRT, to the extent of one or two intervertebral spaces. The patient does not know which of these two procedures they will undergo. The patient agrees that they will find out detailed information on the implementation of the performance after the study’s completion. The patient, however, may at any time request a detailed report on the performed procedure. In this case, they will be immediately provided with all data relating to the ongoing treatment process. They will also be excluded from the reference group of study patients. The patient will be assigned an identification number generated by a random number generator. After filling in the first protocol from the examination before the procedure, the protocol is sent to the study coordinator and the person charged with the study data processing. The first and second postoperative examinations of the patient is carried out by another doctor (not engaged in the study), or at another pain clinic, and the examination protocols are filled in again.
Patients meeting the inclusion criteria will be randomly divided into Groups A and B; patients assigned to Group A will undergo a minimally invasive procedure during which the PRT will be carried out in one intervertebral space. Patients assigned to Group B will undergo a minimally invasive procedure during which the PRT will be done in two adjacent intervertebral spaces.
- Patients included in Group A – 1 nerve root block at the point corresponding to the symptomatology
- Patients involved in Group B – 2 nerve root block: one at the point corresponding to the symptomatology and another at the compression point as confirmed by MRI imaging
The first postoperative check-up is ensured by the study coordinator after 6 months and the second post-operative check-up after 12 months.
EPC I study diagram
Objectives of EPC Study I and Outcome Measures
The aim of the project is to compare the clinical status of patients who underwent the PRT procedure and were enrolled in EPC Study I, upon compliance with indicated criteria. 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.