EuroPainClinics® Study IV (Prospective Observational Study)

Study Overview
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Brief Summary
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In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive therapy should be examined in (approximately 150) adult patients with low back pain positive for facet joint pain component.

Detailed Description
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Facet joint pain encompasses a significant portion of possible sources of pain in patients with vertebrogenic algic syndrome. A typical symptom is intermittent radiation of pain in the back and legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root, which innervates a facet joint. Confirmation of the source of pain involves using a local anaesthetic to block the medial branches of several vertebral areas. If, through this test, the facet joints are determined to be the source of pain the patient's condition is indicated for radiofrequency ablation of the nerve branches. EuroPainClinics® Study IV (EPCS IV) is a prospective observational comparative study that will use pain scales to analyse changes in the neurological status of nerves of patients who undergo the minimally invasive procedure: radiofrequency nerve ablation and cryoablation of the lumber facet joints. The study aims to investigate documented clinical results of the neurological conditions of patients, to compare pain scales and the use of analgesics over a number of time periods: prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure. The data will be subsequently statistically analysed.

Official Title
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EuroPainClinics® Study IV (Prospective Observational Study)

Conditions
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Low Back Pain, Facet Joint Pain

Intervention / Treatment
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* Procedure: Endoscopic rhizotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo Endoscopic rhizotomy therapy Exclusion Criteria: No

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One side endoscopic rhizotomy<br>Endoscopic rhizotomy will be provided only on one back side according pain | Procedure: Endoscopic rhizotomy<br>* Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.<br>|
| Both sides endoscopic rhizotomy<br>Endoscopic rhizotomy will be provided on both back sides according pain | Procedure: Endoscopic rhizotomy<br>* Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as assessed by the Visual analogue scale | All acquired information will be noted in to the special anonymous protocol | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain localization as assessed by note of radiating dermatome as neurologic examination | All acquired information will be noted in to the special anonymous protocol | 4 years | 
| Pain progress as assessed by global pain scale | All acquired information will be noted in to the special anonymous protocol | 4 years | 
| Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids | All acquired information will be noted in to the special anonymous protocol | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Facet joints, Endoscopic rhizotomy