Chronic Pain, Sacroiliac Joint Pain
Conditions
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.
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.
Interventions
PROCEDURECryoablation
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.
PROCEDUREEndoscopic Denervation
Endoscopic denervation of the dorsal branches of L5 and S1-S3 for treatment of posterior sacroiliac joint pain after a positive diagnostic block.
Sponsors
EPC Education s.r.o.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study. Neither participants nor investigators were masked to the performed intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by Numeric Rating Scale (NRS) | 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). |
| Functional disability measured by Oswestry Disability Index (ODI) | Baseline and 12 months follow-up | Change in functional disability assessed using the Oswestry Disability Index (0-100%, higher scores indicate greater disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline EuroQol-5 Dimension (EQ-5D-5L) at 12 Months | 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. |
| Procedure-Related Complications | From procedure up to 24 months follow-up | Occurrence and type of adverse events or complications related to cryoablation or endoscopic denervation. |
| Analgesic consumption measured as daily dose (mg/day) | Baseline and 12 months follow-up | Change in analgesic medication use expressed as daily dose in milligrams per day. |
Countries
Slovakia
Outcome results
None listed