EuroPainClinics® Study III (Prospective Observational Study)

NCT ID: NCT02461654

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

Disc Herniations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who undergo Disc FX therapy

Exclusion Criteria

• No

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Europainclinics z.ú.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juraj Mláka, MD PhD

Role: STUDY_CHAIR

R-Clinic

Ladislav Kočan, MD PhD

Role: STUDY_DIRECTOR

K-medicine

Locations

Algesiology ambulance

Prague, , Czechia

Countries

Czechia

Other Identifiers

9N-2015

Identifier Type: -

Identifier Source: org_study_id