EuroPainClinics® Study IV (Prospective Observational Study)

NCT03039296 | Terminated DMC

• 1 other identifier: 5N/2016
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Facet Joint Pain

Keywords

Low back pain; Facet joints; Endoscopic rhizotomy

Outcome Measures

Primary Outcomes (1)

• Pain as assessed by the Visual analogue scale

  All acquired information will be noted in to the special anonymous protocol

  4 years

Secondary Outcomes (3)

• Pain localization as assessed by note of radiating dermatome as neurologic examination

  4 years

• Pain progress as assessed by global pain scale

  4 years

• Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids

  4 years

Study Arms (2)

One side endoscopic rhizotomy

Endoscopic rhizotomy will be provided only on one back side according pain

Procedure: Endoscopic rhizotomy

Both sides endoscopic rhizotomy

Endoscopic rhizotomy will be provided on both back sides according pain

Procedure: Endoscopic rhizotomy

Interventions

Endoscopic rhizotomy PROCEDURE

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.

Both sides endoscopic rhizotomy; One side endoscopic rhizotomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who undergo Endoscopic rhizotomy therapy

Sponsors & Collaborators

• Europainclinics z.ú.: lead

Study Sites (1)

Europainclinics

Košice, 04011, Slovakia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ladislav Kočan, MD PhD

  europainclinicsstudy@gmail.com

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: February 3, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 18, 2022

Record last verified: 2021-12

Locations

SL (1)