Failed Back Surgery SyndromeEPCS IXNCT04686903
EuroPainClinicsStudy IX
A study testing Epiduroscopy treatment, Racz catheter epidural procedure and Caudal epidural block in people with Failed Back Surgery Syndrome, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- Epiduroscopy treatment, Racz catheter epidural procedure and Caudal epidural block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 20 and 80
- patients with FBSS (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (VAS >=5) on lower extremities
- those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form
Who cannot join
- more than 2 lumbar laminectomies
- patients without previous spine surgery
- patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
- women with a positive pregnancy test before the trial or who planned to become pregnant within the following 3 years
- other patients viewed as inappropriate by the staff
- disagreement with participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparison Between Epiduroscopy Procedure, Racz Catheter Procedure and Caudal Epidural Block in Patients With FBSS
Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS
Read the detailed description
- Epiduroscopy is an advanced proven diagnostic and therapeutic method for chronic radicular pain after spinal surgery. Moreover, this method is frequently used in patients with chronic low back pain conditions without previous spine surgery also known as "virgin back". Epiduroscopy allows by optical fiber technology and skiascopy imaging the exact examination of the epidural space and subsequently mechanical lysis (with advanced interventional options by laser, radiofrequency, balloon techniques etc.) and/or drug administration to the target point.
II. The Racz catheter procedure is based on epidural neurolysis. It is used to release some of the adhesions or scar tissue which surround entrapped nerves in the epidural space of the spine. This state could be caused by chronic inflammatory adhesions or by healing mechanisms after spine surgery - scars. Mechanical liberation of epidural space further allows better administration and targeting of drugs as corticoids or hyaluronidase. This technique is performed under fluoroscopy imaging. Suitable epidurogram and skiascopy confirm appropriate catheter position during procedure.
III. The caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach to the epidural space is popular in managing a wide variety of chronic pain conditions in adults, especially chronic low back pain syndromes. Fluoroscopy is considered as a gold standard of needle guidance during procedures in which caudal epidural injections are performed.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Epiduroscopy treatment, Racz catheter epidural procedure, Caudal epidural block
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiduroscopy treatmentProcedure or surgery
Device Epiduroscop, procedure mecahnical lysis, laser, radiofrequency + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) Follow-up: before procedure, 6 months and 12 months after procedure
Racz catheter epidural procedureProcedure or surgery
Device Racz catheter, two procedures during clinical trial observation
- First procedure after enrolment into the study mechanical lysis and drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)
- Second procedure after 6 months mechanical lysis + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)
Caudal epidural blockProcedure or surgery
Technique Caudal epidural block
Three procedures during clinical trial observation :
- First procedure after enrolment into the study drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)
- Second procedure after 4 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg)
- Third procedure after 8 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg)
| Study group | Role | What they receive |
|---|---|---|
| Epiduroscopy | Experimental | Epiduroscopy in patients with FBSS Receives: Procedure: Epiduroscopy treatment |
| Racz catheter epidural procedure | Experimental | Racz catheter epidural procedure in patients with FBSS Receives: Procedure: Racz catheter epidural procedure |
| Caudal epidural block | Experimental | Caudal epidural block treatment of FBSS Receives: Procedure: Caudal epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Measured: 6 months follow-up
Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Measured: 12 months follow-up
Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m
VAS 10 point measurement
Measured: 6 months follow-up
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m
VAS 10 point measurement
Measured: 12 months follow-up
Oswestry disability index (ODI) 6m
he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.
Measured: 6 months follow-up
Oswestry disability index (ODI) 12m
he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.
Measured: 12 months follow-up
Secondary outcomes (3)
Before procedure drug usage
drug usage
Measured: before procedure
Postprocedural drug usage
drug usage
Measured: before procedure
Radiation exposure
Dose of radiation exposure
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2020
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 paralel groups: Group A Epiduroscopy in patients with FBSS (50 patients) Group B Racz catheter epidural procedure in patients with FBSS (50 patients) Group C Caudal epidural block in patients with FBSS (50 patients)
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, Slovak Academy of Sciences, Pavol Jozef Safarik University
- Responsible party
- Sponsor
- Investigators
- Miroslav Burianek, MD MBA, Study chair, EPC Education s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686903
- Sponsor's protocol ID
- 03595/2020/OZ-30
- Acronym
- EPCS IX
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: encrypted database
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between Epiduroscopy Procedure, Racz Catheter Procedure and Caudal Epidural Block in Patients With FBSS
- ClinicalTrials.gov ID
- NCT04686903
- Acronym / sponsor ID
- EPCS IX / 03595/2020/OZ-30
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Collaborators
- Brno University Hospital, Slovak Academy of Sciences, Pavol Jozef Safarik University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Dec 2020 (actual)
- 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.
Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS
Detailed description
- Epiduroscopy is an advanced proven diagnostic and therapeutic method for chronic radicular pain after spinal surgery. Moreover, this method is frequently used in patients with chronic low back pain conditions without previous spine surgery also known as "virgin back". Epiduroscopy allows by optical fiber technology and skiascopy imaging the exact examination of the epidural space and subsequently mechanical lysis (with advanced interventional options by laser, radiofrequency, balloon techniques etc.) and/or drug administration to the target point.
II. The Racz catheter procedure is based on epidural neurolysis. It is used to release some of the adhesions or scar tissue which surround entrapped nerves in the epidural space of the spine. This state could be caused by chronic inflammatory adhesions or by healing mechanisms after spine surgery - scars. Mechanical liberation of epidural space further allows better administration and targeting of drugs as corticoids or hyaluronidase. This technique is performed under fluoroscopy imaging. Suitable epidurogram and skiascopy confirm appropriate catheter position during procedure.
III. The caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach to the epidural space is popular in managing a wide variety of chronic pain conditions in adults, especially chronic low back pain syndromes. Fluoroscopy is considered as a gold standard of needle guidance during procedures in which caudal epidural injections are performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 paralel groups: Group A Epiduroscopy in patients with FBSS (50 patients) Group B Racz catheter epidural procedure in patients with FBSS (50 patients) Group C Caudal epidural block in patients with FBSS (50 patients)
| Arm | Type | Receives |
|---|---|---|
| Epiduroscopy | Experimental | Procedure: Epiduroscopy treatmentEpiduroscopy in patients with FBSS |
| Racz catheter epidural procedure | Experimental | Procedure: Racz catheter epidural procedureRacz catheter epidural procedure in patients with FBSS |
| Caudal epidural block | Experimental | Procedure: Caudal epidural blockCaudal epidural block treatment of FBSS |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged between 20 and 80
- patients with FBSS (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (VAS >=5) on lower extremities
- those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form
Key exclusion criteria (6 listed)
- more than 2 lumbar laminectomies
- patients without previous spine surgery
- patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
- women with a positive pregnancy test before the trial or who planned to become pregnant within the following 3 years
- other patients viewed as inappropriate by the staff
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 |
|---|---|---|
| Epiduroscopy treatmentDevice Epiduroscop, procedure mecahnical lysis, laser, radiofrequency + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) Follow-up: before procedure, 6 months and 12 months after procedure | Procedure or surgery | Epiduroscopy |
| Racz catheter epidural procedureDevice Racz catheter, two procedures during clinical trial observation * First procedure after enrolment into the study mechanical lysis and drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) * Second procedure after 6 months mechanical lysis + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) | Procedure or surgery | Racz catheter epidural procedure |
| Caudal epidural blockTechnique Caudal epidural block Three procedures during clinical trial observation : * First procedure after enrolment into the study drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) * Second procedure after 4 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg) * Third procedure after 8 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg) | Procedure or surgery | Caudal epidural block |
Primary outcome
Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m
Time frame: 6 months follow-up
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m
Time frame: 12 months follow-up
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m
Time frame: 6 months follow-up
VAS 10 point measurement
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m
Time frame: 12 months follow-up
VAS 10 point measurement
Oswestry disability index (ODI) 6m
Time frame: 6 months follow-up
he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.
Oswestry disability index (ODI) 12m
Time frame: 12 months follow-up
he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.
3 secondary outcomes
Before procedure drug usage
Time frame: before procedure
Postprocedural drug usage
Time frame: before procedure
Radiation exposure
Time frame: 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No. encrypted database
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SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
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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.
Miroslav Burianek, MD MBA study chair
EPC Education s.r.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epiduroscopy treatment, Racz catheter epidural procedure and Caudal epidural block in people with Failed Back Surgery Syndrome, 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m (time frame: 6 months follow-up). The study lists 6 primary outcomes in all. 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 3 Jan 2022.