Clinical trial NCT03039296: EuroPainClinics® Study IV (Prospective Observational Study)
Official title: EuroPainClinics® Study IV (Prospective Observational Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain
Facet Joint Pain
Keywords: Low back pain
Facet joints
Endoscopic rhizotomy
Lead sponsor: Europainclinics z.ú.
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who undergo Endoscopic rhizotomy therapy

Exclusion Criteria:

* No

Primary outcomes:
measure: Pain as assessed by the Visual analogue scale
timeFrame: 4 years
Secondary outcomes:
measure: Pain localization as assessed by note of radiating dermatome as neurologic examination
timeFrame: 4 years
measure: Pain progress as assessed by global pain scale
timeFrame: 4 years
measure: Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
timeFrame: 4 years
Other outcomes:
Locations:
city: Košice
country: Slovakia
facility: Europainclinics
Study officials:
affiliation: europainclinicsstudy@gmail.com
name: Ladislav Kočan, MD PhD
role: STUDY_DIRECTOR
References: