EuroPainClinics® Study IV (Prospective Observational Study)

Low Back Pain Clinical Trial

— EPCSIV  

Official title:

EuroPainClinics® Study IV (Prospective Observational Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03039296
• Other study ID #: 5N/2016
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Arthralgia
• Back Pain
• Facet Joint Pain
• Low Back Pain

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