Back PainEPCS XIr-ZjNCT05813639
EuroPainClinicsStudy XIr-Zj
A study testing Lumbar medial branch cryo ablation neurotomy, Lumbar medial branch radiofrequency ablation neurotomy and Endoscopic denervation of fazet joint in people with Back Pain, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Lumbar medial branch cryo ablation neurotomy, Lumbar medial branch radiofrequency ablation neurotomy and Endoscopic denervation of fazet joint
- 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
- 2 Apr 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application
- positive patient history of facet joint pain
- patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS >=5)
- 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
- patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
- women with positive a pregnancy tests 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: EuroPainClinicsStudy XIr-Zj (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)
Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
Read the detailed description
Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome.A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the 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 the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches. Description of interventional procedures: Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.
- Conditions
- Back Pain
- Being tested
- Lumbar medial branch cryo ablation neurotomy, Lumbar medial branch radiofrequency ablation neurotomy, Endoscopic denervation of fazet joint
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar medial branch cryo ablation neurotomyProcedure or surgery
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Lumbar medial branch radiofrequency ablation neurotomyProcedure or surgery
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Endoscopic denervation of fazet jointProcedure or surgery
The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach
| Study group | Role | What they receive |
|---|---|---|
| Lumbar medial branch cryoablation | Experimental | Lumbar medial branch cryoablation Procedure lumbar medial branch cryoablation Decreasing the electrode temperature to - 85 C for 120 seconds in two cycles. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure Repeated cryoablation ablation procedures are allowed (when VAS will be =/> 4 ) Procedure/Surgery: Lumbar medial branch cryo ablation neurotomy A procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy Receives: Procedure: Lumbar medial branch cryo ablation neurotomy |
| Lumbar medial branch RF neurotomy | Experimental | Lumbar medial branch RF neurotomy Procedure lumbar medial branch RF neurotomy: Raising the temperature of the tip of the electrode to 85 C for 120 seconds. RF generator. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure. Repeated cryoablation ablation procedures are allowed (when VAS will be > 4 ) Receives: Procedure: Lumbar medial branch radiofrequency ablation neurotomy |
| Lumbar fazet joint decapsulation | Experimental | Lumbar facet joint decapsulation through an endoscopic approach Receives: Procedure: Endoscopic denervation of fazet joint |
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 36m
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Measured: 36 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 12m
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m measured by VAS 10 point measurement
Measured: 36 months follow-up
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m measured by VAS 10 point measurement
Measured: 36 months follow-up
Oswestry Disability Index (ODI) 12m
The ODI self-administered questionnaire measuring 0-100 scale
Measured: 12 months follow-up
Oswestry Disability Index (ODI) 36m
The ODI self-administered questionnaire measuring 0-100 scale
Measured: 36 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 posted14 Apr 2023
- Study start2 Apr 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospectively randomized patients with positive facet joint syndrome
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- Slovak Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- MD, PhD, FIPP Rapcan, MD, FIPP, Study chair, R-Clinic Bardejov, Slovakia, 085 01
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813639
- Sponsor's protocol ID
- 6146/2022/ODDZ-25513
- Acronym
- EPCS XIr-Zj
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publishing results
Publications
Kocan L, Rapcan R, Mlaka J, Griger M, Poliak L, Lences P, Kovalicova L, Manik E, Sherdil N, Burianek M, Vaskova J. Comparative Effectiveness of Radiofrequency Ablation, Cryoablation, and Endoscopic Denervation for Lumbar Facet Pain: A Multicenter Trial. Spine (Phila Pa 1976). 2026 Jan 1;51(1):1-8. doi: 10.1097/BRS.0000000000005539. Epub 2025 Nov 4.
PubMed 41084911
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EuroPainClinicsStudy XIr-Zj (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)
- ClinicalTrials.gov ID
- NCT05813639
- Acronym / sponsor ID
- EPCS XIr-Zj / 6146/2022/ODDZ-25513
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Collaborators
- Slovak Academy of Sciences
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 14 Apr 2023 (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.
Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
Detailed description
Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome.A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the 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 the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches. Description of interventional procedures: Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Prospectively randomized patients with positive facet joint syndrome
| Arm | Type | Receives |
|---|---|---|
| Lumbar medial branch cryoablation | Experimental | Procedure: Lumbar medial branch cryo ablation neurotomyLumbar medial branch cryoablation Procedure lumbar medial branch cryoablation Decreasing the electrode temperature to - 85 C for 120 seconds in two cycles. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure Repeated cryoablation ablation procedures are allowed (when VAS will be =/> 4 ) Procedure/Surgery: Lumbar medial branch cryo ablation neurotomy A procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy |
| Lumbar medial branch RF neurotomy | Experimental | Procedure: Lumbar medial branch radiofrequency ablation neurotomyLumbar medial branch RF neurotomy Procedure lumbar medial branch RF neurotomy: Raising the temperature of the tip of the electrode to 85 C for 120 seconds. RF generator. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure. Repeated cryoablation ablation procedures are allowed (when VAS will be > 4 ) |
| Lumbar fazet joint decapsulation | Experimental | Procedure: Endoscopic denervation of fazet jointLumbar facet joint decapsulation through an endoscopic approach |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients aged between 20 and 80
- positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application
- positive patient history of facet joint pain
- patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS >=5)
- 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 (5 listed)
- patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
- women with positive a pregnancy tests 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
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 |
|---|---|---|
| Lumbar medial branch cryo ablation neurotomyThe procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy | Procedure or surgery | Lumbar medial branch cryoablation |
| Lumbar medial branch radiofrequency ablation neurotomyThe procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy | Procedure or surgery | Lumbar medial branch RF neurotomy |
| Endoscopic denervation of fazet jointThe procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach | Procedure or surgery | Lumbar fazet joint decapsulation |
Primary outcome
Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 36m
Time frame: 36 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 12m
Time frame: 36 months follow-up
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m measured by VAS 10 point measurement
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m
Time frame: 36 months follow-up
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m measured by VAS 10 point measurement
Oswestry Disability Index (ODI) 12m
Time frame: 12 months follow-up
The ODI self-administered questionnaire measuring 0-100 scale
Oswestry Disability Index (ODI) 36m
Time frame: 36 months follow-up
The ODI self-administered questionnaire measuring 0-100 scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 41084911Kocan L, Rapcan R, Mlaka J, Griger M, Poliak L, Lences P, Kovalicova L, Manik E, Sherdil N, Burianek M, Vaskova J. Comparative Effectiveness of Radiofrequency Ablation, Cryoablation, and Endoscopic Denervation for Lumbar Facet Pain: A Multicenter Trial. Spine (Phila Pa 1976). 2026 Jan 1;51(1):1-8. doi: 10.1097/BRS.0000000000005539. Epub 2025 Nov 4.
- Individual participant dataSharing planned: No. publishing results
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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.
MD, PhD, FIPP Rapcan, MD, FIPP study chair
R-Clinic Bardejov, Slovakia, 085 01
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar medial branch cryo ablation neurotomy, Lumbar medial branch radiofrequency ablation neurotomy and Endoscopic denervation of fazet joint in people with Back 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 36m (time frame: 36 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?
On the ClinicalTrials.gov record for NCT05813639, 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 18 Jun 2026.