Lumbar Spinal StenosisEPCSIINCT02459392
EuroPainClinics® Study II (Prospective Trial)
A study testing Epiduroscopy, Hyaluronic Acid and DepoMedrol in people with Lumbar Spinal Stenosis, run by EPC Education s.r.o. at 1 site in Czechia.
Trial summary
In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be examined in (approximately 300) adult patients with low back pain pain caused by failed back surgery syndrome (FBSS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Epiduroscopy, Hyaluronic Acid and DepoMedrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 31 Dec 2021to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Written informed consent
- Patients with FBSS
- Magnetic resonance examination evidence of intervertebral disc herniation
- Permanent pain radiating to lower limbs despite previous periradicular therapy or caudal block
- Actual Magnetic resonance imaging: lesion without serious spinal stenosis, lesion without serious radicular compression, lesion without serious intervertebral disc herniation
Who cannot join
- Patients not capable of consenting
- Pregnant women or women of child-bearing potential
- Cauda equine syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial)
In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be examined in (approximately 300) adult patients with low back pain pain caused by failed back surgery syndrome (FBSS).
Read the detailed description
A small flexible fibreoptic catheter is inserted in sacral hiatus and the areas of concern can be visualized on the screen. Effective drugs like active enzyme: Hyaluronic acid and corticosteroids then can be injected through the same catheter.
With this method we can eliminate adhesions or scar tissue that may be pulling or irritating specific nerve roots.
Indicated for this procedure are patients with low back pain or sciatic patients who have not had a successful result with back surgery or spine surgery and have experienced continued pain after surgery: Failed back surgery syndrome (FBSS). Trial will compare groups of patients after fulfilment inclusion with Failed back surgery syndrome who will undergo interventional pain release procedure epiduroscopy. Elimination of adhesions, or scar tissue will be provided mechanically (grabbers, balloon techniques, by radiofrequency or laser) and with medical support (Hyaluronic acid and Depo-Medrol administration via epidural catheter).
The first group of patients enrolled in to the trial will undergo only mechanical lysis of epidural adhesions (grabbers, balloon techniques, by radiofrequency or laser).
The second group of patients enrolled in to the trial will undergo mechanical lysis of epidural adhesions together with epidural drug administration (Hyaluronic acid 150 IU and Depo-Medrol 80mg).
After first visit in ambulance patients will be about study informed. After agreement patient will be in to the study involved. Specific unique nine digits number will be assigned to each patient. Then patients will be randomized in to groups by special evaluated software created especially for this study. Patients will agree that about range of epiduroscopy (mechanical or combination of mechanical and drug administration) will be informed until the end of the study. This way will be patients blinded All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire EQ-5D-5LQuestionnaire) .
Second examination will be provided after 6 months. Patients will be in the beginning introduced to doctor only by their unique number. Doctor will be blinded and he will not dispose with information about microinvasive procedure and will examine patient. Data which will be collected: (Visual analogue scale, dermatome where pain is radiating, global pain scale, changes in analgesics drugs consumption). All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire EQ-5D-5LQuestionnaire) .
The third examination will be provided after 12 months same way. Patients will be in the beginning introduced to doctor only by their unique number. Doctor will be blinded and he will not dispose with information about microinvasive procedure and will examine patient. Data which will be collected: (Visual analogue scale, pain radiating dermatome, global pain scale, changes in analgesics drugs consumption). All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire, EQ-5D-5LQuestionnaire).
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Epiduroscopy, Hyaluronic Acid, DepoMedrol
- Keywords
- Epiduroscopy,, Failed back surgery syndrome, Spinal Stenosis with neurologic changes
- Medical subject headings
- Spinal Stenosis, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduroscopyOther
Epiduroscopy has two main uses in the pain clinic:
Releasing epidural adhesions for the relief of chronic sciatica. Adhesions can form around the lower lumbar nerve roots after decompressive surgery for disc disease or after a bad bout of inflammatory sciatica in the absence of surgery. Epidural adhesions can usually be identified on an enhanced magnetic resonance scan using intravenous gadolinium. They also cause uneven spread of X-ray contrast when performing an epidurogram.
Injecting mixtures of local anesthetic and depot steroid around inflamed nerve roots when epidural injections / nerve root blocks have been unsuccessful. The presence of adhesions can prevent epidurally injected drugs from reaching the inflamed nerve roots.
Hyaluronic AcidDrug
Drug administration
DepoMedrolDrug
Drug administration
| Study group | Role | What they receive |
|---|---|---|
| Epiduroscopy mechanical lysis - failed back surgery syndrome | Other | Epiduroscopy only mechanical lysis Receives: Other: Epiduroscopy |
| Epiduroscopy combination - failed back surgery syndrome | Experimental | Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg Receives: Other: Epiduroscopy; Drug: Hyaluronic Acid; Drug: DepoMedrol |
| Epiduroscopy mechanical lysis - chronic low back pain without previous spine surgery | Other | Epiduroscopy only mechanical lysis Receives: Other: Epiduroscopy |
| Epiduroscopy combination - chronic low back pain without previous spine surgery | Experimental | Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg Receives: Other: Epiduroscopy; Drug: Hyaluronic Acid; Drug: DepoMedrol |
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 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start31 Dec 2021
- Primary completion31 Dec 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 Lumbar Spinal StenosisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 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-Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459392
- Sponsor's protocol ID
- 75/EK/15
- Acronym
- EPCSII
- Status last verified
- Dec 2021
- First submitted
- 26 May 2015
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial)
- ClinicalTrials.gov ID
- NCT02459392
- Acronym / sponsor ID
- EPCSII / 75/EK/15
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Epiduroscopy,, Failed back surgery syndrome, Spinal Stenosis with neurologic changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 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 multi-centre double-blind trial the effect of the epiduroscopy will be examined in (approximately 300) adult patients with low back pain pain caused by failed back surgery syndrome (FBSS).
Detailed description
A small flexible fibreoptic catheter is inserted in sacral hiatus and the areas of concern can be visualized on the screen. Effective drugs like active enzyme: Hyaluronic acid and corticosteroids then can be injected through the same catheter.
With this method we can eliminate adhesions or scar tissue that may be pulling or irritating specific nerve roots.
Indicated for this procedure are patients with low back pain or sciatic patients who have not had a successful result with back surgery or spine surgery and have experienced continued pain after surgery: Failed back surgery syndrome (FBSS). Trial will compare groups of patients after fulfilment inclusion with Failed back surgery syndrome who will undergo interventional pain release procedure epiduroscopy. Elimination of adhesions, or scar tissue will be provided mechanically (grabbers, balloon techniques, by radiofrequency or laser) and with medical support (Hyaluronic acid and Depo-Medrol administration via epidural catheter).
The first group of patients enrolled in to the trial will undergo only mechanical lysis of epidural adhesions (grabbers, balloon techniques, by radiofrequency or laser).
The second group of patients enrolled in to the trial will undergo mechanical lysis of epidural adhesions together with epidural drug administration (Hyaluronic acid 150 IU and Depo-Medrol 80mg).
After first visit in ambulance patients will be about study informed. After agreement patient will be in to the study involved. Specific unique nine digits number will be assigned to each patient. Then patients will be randomized in to groups by special evaluated software created especially for this study. Patients will agree that about range of epiduroscopy (mechanical or combination of mechanical and drug administration) will be informed until the end of the study. This way will be patients blinded All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire EQ-5D-5LQuestionnaire) .
Second examination will be provided after 6 months. Patients will be in the beginning introduced to doctor only by their unique number. Doctor will be blinded and he will not dispose with information about microinvasive procedure and will examine patient. Data which will be collected: (Visual analogue scale, dermatome where pain is radiating, global pain scale, changes in analgesics drugs consumption). All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire EQ-5D-5LQuestionnaire) .
The third examination will be provided after 12 months same way. Patients will be in the beginning introduced to doctor only by their unique number. Doctor will be blinded and he will not dispose with information about microinvasive procedure and will examine patient. Data which will be collected: (Visual analogue scale, pain radiating dermatome, global pain scale, changes in analgesics drugs consumption). All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire, EQ-5D-5LQuestionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epiduroscopy mechanical lysis - failed back surgery syndrome | Other | Other: EpiduroscopyEpiduroscopy only mechanical lysis |
| Epiduroscopy combination - failed back surgery syndrome | Experimental | Other: Epiduroscopy, Drug: Hyaluronic Acid, Drug: DepoMedrolEpiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg |
| Epiduroscopy mechanical lysis - chronic low back pain without previous spine surgery | Other | Other: EpiduroscopyEpiduroscopy only mechanical lysis |
| Epiduroscopy combination - chronic low back pain without previous spine surgery | Experimental | Other: Epiduroscopy, Drug: Hyaluronic Acid, Drug: DepoMedrolEpiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 years or older
- Written informed consent
- Patients with FBSS
- Magnetic resonance examination evidence of intervertebral disc herniation
- Permanent pain radiating to lower limbs despite previous periradicular therapy or caudal block
Key exclusion criteria (3 listed)
- Patients not capable of consenting
- Pregnant women or women of child-bearing potential
- Cauda equine syndrome
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 |
|---|---|---|
| EpiduroscopyEpiduroscopy has two main uses in the pain clinic: Releasing epidural adhesions for the relief of chronic sciatica. Adhesions can form around the lower lumbar nerve roots after decompressive surgery for disc disease or after a bad bout of inflammatory sciatica in the absence of surgery. Epidural adhesions can usually be identified on an enhanced magnetic resonance scan using intravenous gadolinium. They also cause uneven spread of X-ray contrast when performing an epidurogram. Injecting mixtures of local anesthetic and depot steroid around inflamed nerve roots when epidural injections / nerve root blocks have been unsuccessful. The presence of adhesions can prevent epidurally injected drugs from reaching the inflamed nerve roots. | Other | Epiduroscopy combination - chronic low back pain without previous spine surgery, Epiduroscopy combination - failed back surgery syndrome, Epiduroscopy mechanical lysis - chronic low back pain without previous spine surgery, Epiduroscopy mechanical lysis - failed back surgery syndrome |
| Hyaluronic AcidDrug administration | Drug | Epiduroscopy combination - chronic low back pain without previous spine surgery, Epiduroscopy combination - failed back surgery syndrome |
| DepoMedrolDrug administration | Drug | Epiduroscopy combination - chronic low back pain without previous spine surgery, Epiduroscopy combination - failed back surgery syndrome |
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 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
Pain localization as assessed by note of radiating dermatome as neurologic examination
Time frame: 3 years
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.
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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
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, Hyaluronic Acid and DepoMedrol in people with Lumbar Spinal Stenosis, 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 6 inclusion and 3 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 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 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?
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 3 Jan 2022.