EuroPainClinics® Study III (Prospective Observational Study)

Terminated

• Conditions: Disc Herniations

• Registration Number: NCT02461654
• Lead Sponsor: Europainclinics z.ú.

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.

Study Timeline

• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-31
• Study First Posted: 2015-06-03
• Study Start: 2018-12-31
• Primary Completion: 2021-05-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Study Completion: 2021-12-31
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients who undergo Disc FX therapy

Exclusion Criteria

• No

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain as assessed by the Visual analogue scale	3 years	All acquired information will be noted in to the special anonymous protocol

Secondary Outcome Measures

Name	Time	Method
Pain progress as assessed by global pain scale	3 years	All acquired information will be noted in to the special anonymous protocol
Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids	3 years	All acquired information will be noted in to the special anonymous protocol
Pain localization as assessed by note of radiating dermatome as neurologic examination	3 years	All acquired information will be noted in to the special anonymous protocol

Trial Locations

Locations (1)

Algesiology ambulance; 🇨🇿 Praha, Czechia