Endoscopic and Cryoablation Denervation for Sacroiliac Joint Pain

NCT07486674 | Completed

• 1 other identifier: SI-DEN-2019
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. The aim is to evaluate and compare the effectiveness of both procedures in reducing pain and improving functional status.

Conditions

Sacroiliac Joint Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline and 12 months follow-up

Secondary Outcomes (3)

• Change From Baseline EuroQol-5 Dimension (EQ-5D-5L) at 12 Months

  Baseline and 12 months follow-up

• Procedure-Related Complications

  From procedure up to 24 months follow-up

• Analgesic consumption measured as daily dose (mg/day)

  Baseline and 12 months follow-up

Study Arms (2)

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.

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.

Procedure: Endoscopic Denervation

Interventions

Cryoablation PROCEDURE

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.

Cryoablation

Endoscopic Denervation PROCEDURE

Endoscopic denervation of the dorsal branches of L5 and S1-S3 for treatment of posterior sacroiliac joint pain after a positive diagnostic block.

Endoscopic Denervation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EPC Education s.r.o.: lead

Study Sites (1)

EuroPainClinics Košice

Košice, Košice Region, 04011, Slovakia

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study. Neither participants nor investigators were masked to the performed intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 20, 2026
• Study Start: April 20, 2023
• Primary Completion: April 20, 2025
• Study Completion: January 15, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

SL (1)