EuroPainClinics® Study IV (Prospective Observational Study)

Terminated

• Conditions: Low Back Pain; Facet Joint Pain
• Interventions: Procedure: Endoscopic rhizotomy

• Registration Number: NCT03039296
• Lead Sponsor: Europainclinics z.ú.

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 Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Study Start: 2017-02-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Patients who undergo Endoscopic rhizotomy therapy

Exclusion Criteria

• No

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
One side endoscopic rhizotomy	Endoscopic rhizotomy	Endoscopic rhizotomy will be provided only on one back side according pain
Both sides endoscopic rhizotomy	Endoscopic rhizotomy	Endoscopic rhizotomy will be provided on both back sides according pain

Primary Outcome Measures

Name	Time	Method
Pain as assessed by the Visual analogue scale	4 years	All acquired information will be noted in to the special anonymous protocol

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Europainclinics; 🇸🇰 Košice, Slovakia