Back PainEPCSVNCT02742311
EuroPainClinics® Study V (Prospective Observational Study)
A study testing Endoscopic disectomy in people with Back Pain and Intervertebral Disc Herniation, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Intervertebral Disc Herniation
- What is being tested?
- Endoscopic disectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSlovakia
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI
Who cannot join
- The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent
Trial locations and contacts
1 site in 1 country.
About this study
In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.
- Conditions
- Back Pain, Intervertebral Disc Herniation
- Being tested
- Endoscopic disectomy
- Medical subject headings
- Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic disectomyProcedure or surgery
Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.
| Study group | Role | What they receive |
|---|---|---|
| transforaminal endoscopic discectomy | Active comparator | Not described Receives: Procedure: Endoscopic disectomy |
| interlaminar endoscopic discectomy | Active comparator | Not described Receives: Procedure: Endoscopic disectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol
All acquired information will be noted in to the special anonymous protocol
Measured: 3 years
Secondary outcomes (3)
2.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
3.Pain progress as assessed by global pain scale
All acquired information will be noted in to the special anonymous protocol
Measured: 3 years
4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
All acquired information will be noted in to the special anonymous protoco
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 posted19 Apr 2016 (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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miroslav Burianek, MD MPH, Study chair, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742311
- Sponsor's protocol ID
- EK: 9N-2015
- Acronym
- EPCSV
- Status last verified
- Dec 2021
- First submitted
- 10 Apr 2016
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rapcan R, Kocan L, Witkovsky V, Rapcanova S, Mlaka J, Tirpak R, Burianek M, Kocanova H, Vaskova J, Gajdos M. Endoscopic discectomy of the herniated intervertebral disc and changes in quality-of-life EQ-5D-5L analysis. Medicine (Baltimore). 2023 Jun 30;102(26):e34188. doi: 10.1097/MD.0000000000034188.
PubMed 37390280
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 V (Prospective Observational Study)
- ClinicalTrials.gov ID
- NCT02742311
- Acronym / sponsor ID
- EPCSV / EK: 9N-2015
- Conditions
- Back Pain, Intervertebral Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 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
- 19 Apr 2016 (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 discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transforaminal endoscopic discectomy | Active comparator | Procedure: Endoscopic disectomy |
| interlaminar endoscopic discectomy | Active comparator | Procedure: Endoscopic disectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI
Key exclusion criteria (1 listed)
- The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent
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 disectomyEndoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work. | Procedure or surgery | interlaminar endoscopic discectomy, transforaminal endoscopic discectomy |
Primary outcome
1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol
Time frame: 3 years
All acquired information will be noted in to the special anonymous protocol
3 secondary outcomes
2.Pain localization as assessed by note of radiating dermatome as neurologic examination
Time frame: 3 years
3.Pain progress as assessed by global pain scale
Time frame: 3 years
4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
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 13 Jan 2022.
- Derived from this study: PubMed 37390280Rapcan R, Kocan L, Witkovsky V, Rapcanova S, Mlaka J, Tirpak R, Burianek M, Kocanova H, Vaskova J, Gajdos M. Endoscopic discectomy of the herniated intervertebral disc and changes in quality-of-life EQ-5D-5L analysis. Medicine (Baltimore). 2023 Jun 30;102(26):e34188. doi: 10.1097/MD.0000000000034188.
- Individual participant dataSharing planned: No
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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 MPH study chair
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic disectomy in people with Back Pain and Intervertebral Disc Herniation, 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: finished, 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 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?
1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742311, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 31 Oct 2026.