Sacroiliac Joint PainSI-DENNCT07486674
Endoscopic and Cryoablation Denervation for Sacroiliac Joint Pain
A study testing Cryoablation and Endoscopic Denervation in people with Sacroiliac Joint Pain and Chronic Pain, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
This interventional study compares cryoablation and endoscopic denervation for the treatment of posterior sacroiliac joint pain in patients with chronic sacroiliac joint pain confirmed by a positive diagnostic block. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sacroiliac Joint Pain, Chronic Pain
- What is being tested?
- Cryoablation and Endoscopic Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSlovakia
- Study dates
- 20 Apr 2023to 15 Jan 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults aged 18 years or older
- chronic sacroiliac joint pain
- positive sacroiliac joint provocation maneuvers
- positive diagnostic block of the dorsal branches of L5 and S1-S3 under fluoroscopic guidance
- at least 70% pain relief after diagnostic block
- ability to understand the study procedures and provide written informed consent
Who cannot join
- radicular pain caused by lumbar disc herniation or other dominant spinal pathology
- spinal tumor, infection, fracture, or inflammatory spinal disease
- coagulation disorder or ongoing anticoagulant therapy contraindicating the procedure
- pregnancy
- severe psychiatric or medical condition preventing reliable follow-up
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating Cryoablation and Endoscopic Denervation of the Dorsal Sacroiliac Joint Innervation (Ramus Dorsalis L5 and S1-S3) in Patients With Sacroiliac Joint Pain
This interventional study compares cryoablation and endoscopic denervation for the treatment of posterior sacroiliac joint pain in patients with chronic sacroiliac joint pain confirmed by a positive diagnostic block. The aim is to evaluate and compare the effectiveness of both procedures in reducing pain and improving functional status.
Read the detailed description
Posterior sacroiliac joint pain is a common cause of chronic low back pain and may substantially impair daily functioning and quality of life. In patients with a positive diagnostic block confirming the sacroiliac joint as the source of pain, interventional procedures targeting the dorsal branches of L5 and S1-S3 may provide pain relief.
This study compares two interventional treatment methods: cryoablation and endoscopic denervation. Patients with confirmed posterior sacroiliac joint pain undergo one of these procedures after diagnostic confirmation of the pain source. Cryoablation is performed on the dorsal branches of L5 and S1-S3. Endoscopic denervation is performed on the same target nerves using an endoscopic approach.
The study evaluates the comparative effectiveness of these procedures in terms of pain reduction and functional improvement over follow-up. The findings may help clarify the role of these two techniques in the management of chronic posterior sacroiliac joint pain.
- Conditions
- Sacroiliac Joint Pain, Chronic Pain
- Being tested
- Cryoablation, Endoscopic Denervation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Percutaneous cryoablation of the dorsal branches of L5 and S1-S3 under imaging guidance for treatment of posterior sacroiliac joint pain after a positive diagnostic block.
Endoscopic DenervationProcedure or surgery
Endoscopic denervation of the dorsal branches of L5 and S1-S3 for treatment of posterior sacroiliac joint pain after a positive diagnostic block.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Patients with sacroiliac joint pain underwent cryoablation of the dorsal branches of L5 and S1-S3 after a positive diagnostic block confirming posterior sacroiliac joint pain. Receives: Procedure: Cryoablation |
| Endoscopic Denervation | Experimental | Patients with sacroiliac joint pain underwent endoscopic denervation of the dorsal branches of L5 and S1-S3 after a positive diagnostic block confirming posterior sacroiliac joint pain. Receives: Procedure: Endoscopic Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by Numeric Rating Scale (NRS)
Change in pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
Measured: Baseline and 12 months follow-up
Functional disability measured by Oswestry Disability Index (ODI)
Change in functional disability assessed using the Oswestry Disability Index (0-100%, higher scores indicate greater disability).
Measured: Baseline and 12 months follow-up
Secondary outcomes (3)
Change From Baseline EuroQol-5 Dimension (EQ-5D-5L) at 12 Months
Change in health-related quality of life assessed using the EQ-5D-5L questionnaire, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline and 12 months follow-up
Procedure-Related Complications
Occurrence and type of adverse events or complications related to cryoablation or endoscopic denervation.
Measured: From procedure up to 24 months follow-up
Analgesic consumption measured as daily dose (mg/day)
Change in analgesic medication use expressed as daily dose in milligrams per day.
Measured: Baseline and 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 posted20 Mar 2026
- Study start20 Apr 2023
- Primary completion20 Apr 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint 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
- Model description
- Patients with sacroiliac joint pain and a positive diagnostic block of the dorsal branches of L5 and S1-S3 were assigned to one of two treatment groups according to the performed intervention: cryoablation or endoscopic denervation.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486674
- Sponsor's protocol ID
- SI-DEN-2019
- Acronym
- SI-DEN
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating Cryoablation and Endoscopic Denervation of the Dorsal Sacroiliac Joint Innervation (Ramus Dorsalis L5 and S1-S3) in Patients With Sacroiliac Joint Pain
- ClinicalTrials.gov ID
- NCT07486674
- Acronym / sponsor ID
- SI-DEN / SI-DEN-2019
- Conditions
- Sacroiliac Joint Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 20 Mar 2026 (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.
This interventional study compares cryoablation and endoscopic denervation for the treatment of posterior sacroiliac joint pain in patients with chronic sacroiliac joint pain confirmed by a positive diagnostic block. The aim is to evaluate and compare the effectiveness of both procedures in reducing pain and improving functional status.
Detailed description
Posterior sacroiliac joint pain is a common cause of chronic low back pain and may substantially impair daily functioning and quality of life. In patients with a positive diagnostic block confirming the sacroiliac joint as the source of pain, interventional procedures targeting the dorsal branches of L5 and S1-S3 may provide pain relief.
This study compares two interventional treatment methods: cryoablation and endoscopic denervation. Patients with confirmed posterior sacroiliac joint pain undergo one of these procedures after diagnostic confirmation of the pain source. Cryoablation is performed on the dorsal branches of L5 and S1-S3. Endoscopic denervation is performed on the same target nerves using an endoscopic approach.
The study evaluates the comparative effectiveness of these procedures in terms of pain reduction and functional improvement over follow-up. The findings may help clarify the role of these two techniques in the management of chronic posterior sacroiliac joint pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with sacroiliac joint pain and a positive diagnostic block of the dorsal branches of L5 and S1-S3 were assigned to one of two treatment groups according to the performed intervention: cryoablation or endoscopic denervation.
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Procedure: CryoablationPatients with sacroiliac joint pain underwent cryoablation of the dorsal branches of L5 and S1-S3 after a positive diagnostic block confirming posterior sacroiliac joint pain. |
| Endoscopic Denervation | Experimental | Procedure: Endoscopic DenervationPatients with sacroiliac joint pain underwent endoscopic denervation of the dorsal branches of L5 and S1-S3 after a positive diagnostic block confirming posterior sacroiliac joint pain. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults aged 18 years or older
- chronic sacroiliac joint pain
- positive sacroiliac joint provocation maneuvers
- positive diagnostic block of the dorsal branches of L5 and S1-S3 under fluoroscopic guidance
- at least 70% pain relief after diagnostic block
Key exclusion criteria (6 listed)
- radicular pain caused by lumbar disc herniation or other dominant spinal pathology
- spinal tumor, infection, fracture, or inflammatory spinal disease
- coagulation disorder or ongoing anticoagulant therapy contraindicating the procedure
- pregnancy
- severe psychiatric or medical condition preventing reliable follow-up
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 |
|---|---|---|
| CryoablationPercutaneous cryoablation of the dorsal branches of L5 and S1-S3 under imaging guidance for treatment of posterior sacroiliac joint pain after a positive diagnostic block. | Procedure or surgery | Cryoablation |
| Endoscopic DenervationEndoscopic denervation of the dorsal branches of L5 and S1-S3 for treatment of posterior sacroiliac joint pain after a positive diagnostic block. | Procedure or surgery | Endoscopic Denervation |
Primary outcome
Pain intensity measured by Numeric Rating Scale (NRS)
Time frame: Baseline and 12 months follow-up
Change in pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
Functional disability measured by Oswestry Disability Index (ODI)
Time frame: Baseline and 12 months follow-up
Change in functional disability assessed using the Oswestry Disability Index (0-100%, higher scores indicate greater disability).
3 secondary outcomes
Change From Baseline EuroQol-5 Dimension (EQ-5D-5L) at 12 Months
Time frame: Baseline and 12 months follow-up
Procedure-Related Complications
Time frame: From procedure up to 24 months follow-up
Analgesic consumption measured as daily dose (mg/day)
Time frame: Baseline and 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 20 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation and Endoscopic Denervation in people with Sacroiliac Joint Pain and Chronic 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 6 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 20 Mar 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?
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 intensity measured by Numeric Rating Scale (NRS) (time frame: Baseline and 12 months follow-up). The study lists 2 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 20 Mar 2026.