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Completed

NCT Number: NCT07486674

Endoscopic and Cryoablation Denervation for 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EuroPainClinics Košice

Košice, Košice Region, 04011, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

EPC Education s.r.o.

Other

Registry information

Official study 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

Acronym: SI-DEN

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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