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EuroPainClinics® Study IV (Prospective Observational Study) (EPCSIV)

E

Europainclinics z.ú.

Status

Terminated

Conditions

Facet Joint Pain
Low Back Pain

Treatments

Procedure: Endoscopic rhizotomy

Study type

Observational

Funder types

Other

Identifiers

NCT03039296
5N/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who undergo Endoscopic rhizotomy therapy

Exclusion criteria

  • No

Trial design

4 participants in 2 patient groups

One side endoscopic rhizotomy
Description:
Endoscopic rhizotomy will be provided only on one back side according pain
Treatment:
Procedure: Endoscopic rhizotomy
Both sides endoscopic rhizotomy
Description:
Endoscopic rhizotomy will be provided on both back sides according pain
Treatment:
Procedure: Endoscopic rhizotomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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