EuroPainClinics® Study III (Prospective Observational Study)

Disc Herniations Clinical Trial

— EPCSIII  

Official title:

EuroPainClinics® Study III (Prospective Observational Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02461654
• Other study ID #: 9N-2015
• Status: Terminated
• Start date: December 31, 2018
• 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

Clinical Trial Summary

In this prospective observational trial the effect of the Disc FX microinvasive therapy should be examined in (approximately 150) adult patients with low back pain.

Description:

Patients will be selected from 4 participating clinics from Czech and Slovak republic. Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

Back pain due to Lumbar Disc Disease in our population is a very common problem. The treatment options range from physiotherapy to fusion surgery. When all conservative treatment is failed than in some cases with suitable conditions of intervertebral disc is possible to avoid classical disc surgery with minimally invasive surgery techniques. A number of minimally invasive procedures have also been developed in the recent past for its management. One of them is Disc FX procedure. Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. This method provides an option for those people who have not benefited from conservative treatment, and are not yet ready for major surgery. It is a minimal-access procedure performed on an out-patient basis. Its big advantage is the fact that the patient may go home the same day. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.

Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who undergo Disc FX therapy

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Disc Herniations
• Hernia

Intervention

Other:
• Disc FX
Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.

Locations

Country	Name	City	State
Czechia	Algesiology ambulance	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Europainclinics z.ú.

Country where clinical trial is conducted

Czechia, 

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	3 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	3 years
Secondary	Pain progress as assessed by global pain scale	All acquired information will be noted in to the special anonymous protocol	3 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	3 years