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Trial record 10 of 1556 for:    Slovakia

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

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ClinicalTrials.gov Identifier: NCT03039296
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Low Back Pain Facet Joint Pain Procedure: Endoscopic rhizotomy

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 at 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 Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: EuroPainClinics® Study IV (Prospective Observational Study)
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Endoscopy

Group/Cohort Intervention/treatment
One side endoscopic rhizotomy
Endoscopic rhizotomy will be provided only on one back side according pain
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.

Both sides endoscopic rhizotomy
Endoscopic rhizotomy will be provided on both back sides according pain
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.




Primary Outcome Measures :
  1. Pain as assessed by the Visual analogue scale [ Time Frame: 4 years ]
    All acquired information will be noted in to the special anonymous protocol


Secondary Outcome Measures :
  1. Pain localization as assessed by note of radiating dermatome as neurologic examination [ Time Frame: 4 years ]
    All acquired information will be noted in to the special anonymous protocol

  2. Pain progress as assessed by global pain scale [ Time Frame: 4 years ]
    All acquired information will be noted in to the special anonymous protocol

  3. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids [ Time Frame: 4 years ]
    All acquired information will be noted in to the special anonymous protocol



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Patients who undergo Endoscopic rhizotomy therapy

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039296


Contacts
Contact: Miroslav Burianek, MD MBA 905440250 burianek@europainclinics.com
Contact: Robert Rapčan, MD FIPP 905440250 rorapcan007@yahoo.com

Locations
Slovakia
Europainclinics Recruiting
Kosicky Kraj, Slovakia
Contact: Ladislav Kočan, MD PhD         
Sponsors and Collaborators
Europainclinics z.ú.
Investigators
Study Director: Ladislav Kočan, MD PhD europainclinicsstudy@gmail.com

Responsible Party: Europainclinics z.ú.
ClinicalTrials.gov Identifier: NCT03039296     History of Changes
Other Study ID Numbers: 5N/2016
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Europainclinics z.ú.:
Low back pain
Facet joints
Endoscopic rhizotomy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Arthralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases