Disc HerniationsEPCSIIINCT02461654
EuroPainClinics® Study III (Prospective Observational Study)
An observational study of Disc Herniations, run by EPC Education s.r.o. at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disc Herniations
- What is being tested?
- Disc FX
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 31 Dec 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who undergo Disc FX therapy
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Disc FX
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disc FXOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as assessed by the Visual analogue scale
All acquired information will be noted in to the special anonymous protocol
Measured: 3 years
Secondary outcomes (3)
Pain localization as assessed by note of radiating dermatome as neurologic examination
All acquired information will be noted in to the special anonymous protocol
Measured: 3 years
Pain progress as assessed by global pain scale
All acquired information will be noted in to the special anonymous protocol
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start31 Dec 2018
- Primary completion31 May 2021
- Study completion31 Dec 2021
Why it stopped: The clinical trial was suspended for the reason that preliminary results in 20 patients didn't show a significant curative effect of observed treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc HerniationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juraj Mláka, MD PhD, Study chair, R-ClinicLadislav Kočan, MD PhD, Study director, K-medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461654
- Sponsor's protocol ID
- 9N-2015
- Acronym
- EPCSIII
- Status last verified
- Dec 2021
- First submitted
- 26 May 2015
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EuroPainClinics® Study III (Prospective Observational Study)
- ClinicalTrials.gov ID
- NCT02461654
- Acronym / sponsor ID
- EPCSIII / 9N-2015
- Conditions
- Disc Herniations
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The clinical trial was suspended for the reason that preliminary results in 20 patients didn't show a significant curative effect of observed treatment.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who undergo Disc FX therapy
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disc FXDisc 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. | Other | – |
Primary outcome
Pain as assessed by the Visual analogue scale
Time frame: 3 years
All acquired information will be noted in to the special anonymous protocol
3 secondary outcomes
Pain localization as assessed by note of radiating dermatome as neurologic examination
Time frame: 3 years
Pain progress as assessed by global pain scale
Time frame: 3 years
Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
Time frame: 3 years
Results and safety
The study was stopped early (reason given: The clinical trial was suspended for the reason that preliminary results in 20 patients didn't show a significant curative effect of observed treatment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juraj Mláka, MD PhD study chair
R-Clinic
Ladislav Kočan, MD PhD study director
K-medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disc Herniations, run by EPC Education s.r.o. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The clinical trial was suspended for the reason that preliminary results in 20 patients didn't show a significant curative effect of observed treatment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as assessed by the Visual analogue scale (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.