Endoscopic and Cryoablation Denervation for Sacroiliac Joint Pain (SI-DEN)

March 18, 2026 updated by: EPC Education s.r.o.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
    • Košice Region
      • Košice, Košice Region, Slovakia, 04011
        • EuroPainClinics Košice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoablation
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.
Procedure: Cryoablation
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.
Experimental: Endoscopic Denervation
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.
Procedure: Endoscopic Denervation
Endoscopic denervation of the dorsal branches of L5 and S1-S3 for treatment of posterior sacroiliac joint pain after a positive diagnostic block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 12 months follow-up
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).
Baseline and 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline EuroQol-5 Dimension (EQ-5D-5L) at 12 Months
Time Frame: Baseline and 12 months follow-up
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.
Baseline and 12 months follow-up
Procedure-Related Complications
Time Frame: From procedure up to 24 months follow-up
Occurrence and type of adverse events or complications related to cryoablation or endoscopic denervation.
From procedure up to 24 months follow-up
Analgesic consumption measured as daily dose (mg/day)
Time Frame: Baseline and 12 months follow-up
Change in analgesic medication use expressed as daily dose in milligrams per day.
Baseline and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EPC Education s.r.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

April 20, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-DEN-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Cryoablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe