EuroPainClinics Košice
Košice, Košice Region, 04011, Slovakia
NCT Number: NCT07486674
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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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Košice, Košice Region, 04011, Slovakia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 of the dorsal branches of L5 and S1-S3 for treatment of posterior sacroiliac joint pain after a positive diagnostic block.
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).
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).
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.
Time frame: From procedure up to 24 months follow-up
Occurrence and type of adverse events or complications related to cryoablation or endoscopic denervation.
Time frame: Baseline and 12 months follow-up
Change in analgesic medication use expressed as daily dose in milligrams per day.
EPC Education s.r.o.
Other
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
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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