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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03039296
Other study ID # 5N/2016
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 3, 2017
Est. completion date December 31, 2021

Study information

Verified date December 2021
Source Europainclinics z.ú.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients who undergo Endoscopic rhizotomy therapy Exclusion Criteria: - No

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic rhizotomy
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.

Locations

Country Name City State
Slovakia Europainclinics Košice

Sponsors (1)

Lead Sponsor Collaborator
Europainclinics z.ú.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol 4 years
Secondary 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
Secondary Pain progress as assessed by global pain scale All acquired information will be noted in to the special anonymous protocol 4 years
Secondary 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
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