An observational study in Disc Herniations, sponsored by EPC Education s.r.o.. Terminated at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by EPC Education s.r.o. · Observational
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.
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.
491 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 123 observational studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →EPC Education s.r.o. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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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.
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Exclusion Criteria:
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.
Pain as assessed by the Visual analogue scale
All acquired information will be noted in to the special anonymous protocol
Time frame: 3 years
Pain localization as assessed by note of radiating dermatome as neurologic examination
All acquired information will be noted in to the special anonymous protocol
Time frame: 3 years
Pain progress as assessed by global pain scale
All acquired information will be noted in to the special anonymous protocol
Time frame: 3 years
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
Time frame: 3 years
Ran from Dec 2018 to primary completion in May 2021, 29 months.
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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement →
EPC Education s.r.o.