Low Back PainEPCSIVNCT03039296
EuroPainClinics® Study IV (Prospective Observational Study)
An observational study of Low Back Pain and Facet Joint Pain, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive therapy should be examined in (approximately 150) adult patients with low back pain positive for facet joint pain component. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain, Facet Joint Pain
- What is being tested?
- Endoscopic rhizotomy
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteSlovakia
- Study dates
- 3 Feb 2017to 31 Dec 2021
- How long will I take part?
- 4 Years
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study aims to investigate documented clinical results of the neurological conditions of patients, to compare pain scales and the use of analgesics over a number of time periods: prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure. The data will be subsequently statistically analysed.
Who may be able to join
- Patients who undergo Endoscopic rhizotomy 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 Endoscopic rhizotomy microinvasive therapy should be examined in (approximately 150) adult patients with low back pain positive for facet joint pain component.
Read the detailed description
Facet joint pain encompasses a significant portion of possible sources of pain in patients with vertebrogenic algic syndrome. A typical symptom is intermittent radiation of pain in the back and legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root, which innervates a facet joint. Confirmation of the source of pain involves using a local anaesthetic to block the medial branches of several vertebral areas. If, through this test, the facet joints are determined to be the source of pain the patient's condition is indicated for radiofrequency ablation of the nerve branches.
EuroPainClinics® Study IV (EPCS IV) is a prospective observational comparative study that will use pain scales to analyse changes in the neurological status of nerves of patients who undergo the minimally invasive procedure: radiofrequency nerve ablation and cryoablation of the lumber facet joints.
The study aims to investigate documented clinical results of the neurological conditions of patients, to compare pain scales and the use of analgesics over a number of time periods: prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure. The data will be subsequently statistically analysed.
- Conditions
- Low Back Pain, Facet Joint Pain
- Being tested
- Endoscopic rhizotomy
- Keywords
- Low back pain, Facet joints, Endoscopic rhizotomy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic rhizotomyProcedure or surgery
Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.
| Study group | Role | What they receive |
|---|---|---|
| One side endoscopic rhizotomy | Endoscopic rhizotomy will be provided only on one back side according pain Receives: Procedure: Endoscopic rhizotomy | |
| Both sides endoscopic rhizotomy | Endoscopic rhizotomy will be provided on both back sides according pain Receives: Procedure: Endoscopic rhizotomy |
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: 4 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: 4 years
Pain progress as assessed by global pain scale
All acquired information will be noted in to the special anonymous protocol
Measured: 4 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: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start3 Feb 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: The low number of participants was enrolled in to the clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- 4 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ladislav Kočan, MD PhD, Study director, europainclinicsstudy@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039296
- Sponsor's protocol ID
- 5N/2016
- Acronym
- EPCSIV
- Status last verified
- Dec 2021
- First submitted
- 30 Jan 2017
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EuroPainClinics® Study IV (Prospective Observational Study)
- ClinicalTrials.gov ID
- NCT03039296
- Acronym / sponsor ID
- EPCSIV / 5N/2016
- Conditions
- Low Back Pain, Facet Joint Pain
- Keywords
- Low back pain, Facet joints, Endoscopic rhizotomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The low number of participants was enrolled in to the clinical trial
- Enrolment
- 4 participants (actual)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Feb 2017 (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 Endoscopic rhizotomy microinvasive therapy should be examined in (approximately 150) adult patients with low back pain positive for facet joint pain component.
Detailed description
Facet joint pain encompasses a significant portion of possible sources of pain in patients with vertebrogenic algic syndrome. A typical symptom is intermittent radiation of pain in the back and legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root, which innervates a facet joint. Confirmation of the source of pain involves using a local anaesthetic to block the medial branches of several vertebral areas. If, through this test, the facet joints are determined to be the source of pain the patient's condition is indicated for radiofrequency ablation of the nerve branches.
EuroPainClinics® Study IV (EPCS IV) is a prospective observational comparative study that will use pain scales to analyse changes in the neurological status of nerves of patients who undergo the minimally invasive procedure: radiofrequency nerve ablation and cryoablation of the lumber facet joints.
The study aims to investigate documented clinical results of the neurological conditions of patients, to compare pain scales and the use of analgesics over a number of time periods: prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure. The data will be subsequently statistically analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One side endoscopic rhizotomy | – | Procedure: Endoscopic rhizotomyEndoscopic rhizotomy will be provided only on one back side according pain |
| Both sides endoscopic rhizotomy | – | Procedure: Endoscopic rhizotomyEndoscopic rhizotomy will be provided on both back sides according pain |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to investigate documented clinical results of the neurological conditions of patients, to compare pain scales and the use of analgesics over a number of time periods: prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure. The data will be subsequently statistically analysed.
Key inclusion criteria (1 listed)
- Patients who undergo Endoscopic rhizotomy 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 |
|---|---|---|
| Endoscopic rhizotomyEndoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures. | Procedure or surgery | Both sides endoscopic rhizotomy, One side endoscopic rhizotomy |
Primary outcome
Pain as assessed by the Visual analogue scale
Time frame: 4 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: 4 years
Pain progress as assessed by global pain scale
Time frame: 4 years
Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
Time frame: 4 years
Results and safety
The study was stopped early (reason given: The low number of participants was enrolled in to the clinical trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ladislav Kočan, MD PhD study director
europainclinicsstudy@gmail.com
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 Low Back Pain and Facet Joint Pain, run by EPC Education s.r.o. at 1 site in Slovakia.
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 18 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 Slovakia. 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 low number of participants was enrolled in to the clinical trial). 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: 4 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 18 Jan 2022.