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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months follow-up |
| Procedure-Related Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EuroPainClinics Košice | Košice | Košice Region | 04011 | Slovakia |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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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.
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This was an open-label study. Neither participants nor investigators were masked to the performed intervention.
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| 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. |
|
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) | Change in analgesic medication use expressed as daily dose in milligrams per day. | Baseline and 12 months follow-up |