Clinical trial NCT02461654: EuroPainClinics® Study III (Prospective Observational Study)
Official title: EuroPainClinics® Study III (Prospective Observational Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Disc Herniations
Lead sponsor: Europainclinics z.ú.
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 algesiologic procedure - disc FX.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who undergo Disc FX therapy

Exclusion Criteria:

* No

Primary outcomes:
measure: Pain as assessed by the Visual analogue scale
timeFrame: 3 years
Secondary outcomes:
measure: Pain localization as assessed by note of radiating dermatome as neurologic examination
timeFrame: 3 years
measure: Pain progress as assessed by global pain scale
timeFrame: 3 years
measure: Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
timeFrame: 3 years
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Algesiology ambulance
Study officials:
affiliation: R-Clinic
name: Juraj Mláka, MD PhD
role: STUDY_CHAIR
affiliation: K-medicine
name: Ladislav Kočan, MD PhD
role: STUDY_DIRECTOR
References: