EuroPainClinics® Study IV (Prospective Observational Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Europainclinics z.ú.
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Pain as assessed by the Visual analogue scale
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who undergo Endoscopic rhizotomy therapy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pain as assessed by the Visual analogue scale
Time Frame: 4 years
All acquired information will be noted in to the special anonymous protocol
Secondary Outcomes
- Pain localization as assessed by note of radiating dermatome as neurologic examination(4 years)
- Pain progress as assessed by global pain scale(4 years)
- Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids(4 years)