Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain

ClinicalTrials.gov ID: NCT05409443

Public ClinicalTrials.gov record NCT05409443. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Conventional or Bipolar Radiofrequency Ablation for the Treatment of Sacroiliac Joint Pain? The COBRA-SIJ Study, a Double-blinded, Randomized, Comparative Trial.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Specific Aims The sacroiliac joint complex (SIJC) is a diathrodial, synovial joint and posterior ligamentous network that receives both anterior innervation from the lumbosacral plexus as well as posterior sensory innervation via the posterior sacral network (PSN). The PSN is comprised by the lateral branches S1-S3 posterior rami, with variable contributions from S4 lateral branch, L4 medial branch, and L5 dorsal ramus. Pain signals originating from the SIJC can be interrupted with image-guided percutaneous radiofrequency ablation (RFA) of the PSN, thereby reducing pain and disability in carefully selected patients. A prior systematic review estimated that 32-89% of patients achieve at least 50% pain relief for six months after some type of PSN ablation. Many experts suspect that heterogenous RFA techniques and technology are responsible for the variable success rates seen across published studies. Cadaveric work suggests that targeting the PSN with a large bipolar strip lesions would result in \>95% PSN neural capture compared to a smaller lesion produced by a conventional, monopolar, periforaminal RFA technique which may capture as low as 2.5% of the PSN. Nimbus is a commonly used multi-tined RFA probe whose large bipolar lesion size make it an ideal option for complete PSN neural ablation. Both the Nimbus (N-SIJRFA) and conventional (C-SIJRFA) techniques and technologies are commonly used; however, there are no prospective RCT's comparing them, and the clinical significance remains unknown. Problem: There are no randomized controlled trials comparing novel technologies like N-SIJRFA to C-SIJRFA. Purpose: To compare pain and disability outcomes in patients with confirmed SIJC pain after randomization to either N-SIJRFA or C-SIJRFA. Central Hypothesis: N-SIJRFA will be more effective in improving pain and function compared to patients treated with C-SIJRFA at 3, 6, 12, 18, and 24 months. Specific Aims: 1. Compare the proportion of participants who report ≥50% relief of pain by Numeric Pain Rating Scale (NPRS) after N-SIJRFA versus C-SIJRFA. 2. Compare the proportion of participants who report ≥15-point ODI (Oswestry Disability Index) reduction after N-SIJRFA versus C-SIJRFA. 3. Compare the proportion of participants with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) defined by ≥0.03, after N-SIJRFA versus C-SIJRFA. 4. Compare the proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale after N-SIJRFA versus C-SIJRFA. 5. Evaluate the differences in success rates for pain improvement, functional improvement and satisfaction in those experiencing ≥ 50%, ≥ 80%, and 100% pain relief after either prognostic PSN blocks or intra-articular (IA) sacroiliac joint (SIJ) injections. 6. Determine the effect of PSN ablation on reducing pain related sleep disturbance as measured by the Pain and Sleep Questionnaire (PSQ-3). 7. Compare procedural time requirements between those treated with N-SIJRFA versus C-SIJRFA. 8. Report adverse effects. 9. Report rates of subsequent interventional healthcare utilization including repeat N-SIJRFA versus C-SIJRFA, SIJ injection, and SIJ fusion.

Study identification

NCT ID: NCT05409443
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 4
Lead sponsor: University of Utah; Other
Enrollment: 20 participants

Conditions and interventions

Conditions

Interventions

Procedure

Eligibility (public fields only)

Age range: 18 Years to 90 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 14, 2022
Primary completion: Feb 18, 2025
Completion: Mar 9, 2025
Last update posted: Jun 25, 2026

2022 – 2025

United States locations

U.S. sites: 3
U.S. states: 1
U.S. cities: 3

Facility	City	State	ZIP	Site status
University of Utah Farmington Health Center	Farmington	Utah	84025	—
University of Utah Orthopaedic Center	Salt Lake City	Utah	84108	—
University of Utah South Jordan Health Center	South Jordan	Utah	84009	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05409443, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 25, 2026 · Synced Sep 5, 2026

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