EuroPainClinics® Study V
EuroPainClinics®Study V (EPCS V) is a prospective observational comparative study aimed at clinical research of Endoscopic Discectomy treatment methods. The study evaluates changes in the neurological status of treated nerves through evaluation of patients’ pain scales after they have undergone the given interventional procedures and met study criteria. The study is approved by an ethics committee, and a detailed description of the study is available on the international database www.clinicaltrials.gov where it is registered under the identification number PRS: NCT01541163.
Treatment of a Protruding Intervertebral Disc
Description of Back Problems
Back pain is amongst the most common chronic forms of pain experienced, and its diagnosis involves multi-etiological considerations. The most frequent cause of back pain is a disruption in the normal anatomical structures of the spine, and functional changes result in pain as the dominant symptom. Herniation of an intervertebral disc, with a prevalence of 1-3% in developed countries, is the most common reason leading to back surgery.
Endoscopic discectomy is an alternative to open surgery – lumbar hemilaminectomy. It can be performed via transforaminal or intralaminar access. Procedures involving minimally invasive endoscopic techniques have been successfully used in the treatment of degenerative intervertebral discs. The surgery is possible due to the anatomical structural arrangement across the lumbar spine L1-L5 and at the lumbosacral interface L5-S1. The procedure is performed through a one centimetre-wide working channel with minimal trauma to the surrounding tissue. A transforaminal approach spares the spinal dura, which is likely a key factor in the prevention of epidural fibrosis. The most recent evidence demonstrates that endoscopic discectomy has a number of advantages over open surgery. Namely: decreased blood loss, shorter hospitalization and increased patient satisfaction, as well as reduced need for reoperation or other complications.
Topic of EPC Study V and Registration
The study will include those patients who undergo minimally invasive endoscopic discectomy. The course will be for a period of 36 months after the approval by a university ethics committee. It will be run in a number of EuroPainClinics® pain management centres, namely in Prague, Bratislava, Bardejov and Košice. All procedures are employed in the treatment of pain and are approved by the Ministry of Health of the Slovak Republic and the Czech Republic. EPCS V is approved by an ethics committee, and a detailed description of the study is available on the international database www.clinicaltrials.gov where it is registered under the identification number PRS: NCT01541163
Endoscopic Discectomy:Indication Criteria
Selection and Qualification of Patients for the Study
Patients undergoing minimally invasive interventional endoscopic discectomy meeting the following criteria will be approved for participation in the study: one-sided radiation of pain to the lower limbs corresponding to MRI findings, positive Lasegue test, ineffectiveness of conservative pharmacological therapy to-date, positive lumbosacral spine MRI finding (e.g. of intervertebral disc herniation), and consent of the patient. Exclusion criteria: severe stenosis of the spinal canal or segmental instability on MRI, cauda equina syndrome, extreme lateral disc herniation, infection, trauma, or fractures.
Objectives of EPC Study V and Outcome Measures
Blind study, performing the procedure, and data collection:
Patients will be investigated in two groups based on the surgical interventions, for which inclusion in the study has no effect. The patient will be subject to further examination of pain in indicated cases and subject to minimally invasive interventions. Patients meeting the criteria for participation in the study will be informed by the attending physician involved in the study and will be offered the opportunity to participate. If the patient consents, they will be educated about the interventional endoscopic discectomy procedure and will be asked to sign an informed consent for the participation in the controlled study, and an informed consent to undergo the minimally invasive procedure: endoscopic discectomy. The patient will be assigned a randomly generated number. After completing the first protocol of tests prior to the procedure, the protocol is sent to the study coordinator and to those involved with study data processing. The first and second postoperative examination of the patient is performed by a doctor not engaged in the medical procedure or at a different pain clinic and the investigation reports are filled out again. During the post-operative examinations the examining physician will be informed about the patient´s participation in the study. The patient presents with a generated number. The physician will examine the patient without advanced knowledge that the patient has undergone an interventional procedure, and they will subsequently fill out the study protocol and send it in to the individual involved with study data processing. The study will involve those patients who have undergone minimally invasive endoscopic discectomy. The study coordinator ensures the first post-operative control check-up at 6 months and the second at 12 months post-operation.