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NCT05409443 · ClinicalTrials.gov registry record · Phase 4
Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain
A Phase 4 study of Low Back Pain and Sacroiliac Joint Complex, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 116
- Enrollment target
- 3
- Study locations
NCT05409443 is a Phase 4 study of Low Back Pain and Sacroiliac Joint Complex that is actively recruiting participants, run by University of Utah. The registered enrollment target is 116 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (77% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT05409443, a Phase 4 study of Low Back Pain and Sacroiliac Joint Complex, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 116 participants
- Enrollment target
- 3
- Study locations
Study Summary
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%
Conditions Studied
Interventions
- PROCEDURE Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
- PROCEDURE Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
Study Locations (3)
Utah
- University of Utah Farmington Health Center - Farmington
- University of Utah Orthopaedic Center - Salt Lake City
- University of Utah South Jordan Health Center - South Jordan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05409443
The ClinicalTrials.gov registry entry for NCT05409443 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (77% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) is the first listed.
NCT05409443 reports 3 study locations spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT05409443 about?
NCT05409443 is a clinical study titled "Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain". 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 latera...
What is the current status of trial NCT05409443?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 116 participants. The study started on 2022-08-15. Estimated completion is 2027-06-30.
What conditions does trial NCT05409443 study?
This clinical trial studies the following conditions: Low Back Pain, Sacroiliac Joint Complex.
What interventions are being tested in trial NCT05409443?
The interventions under investigation include: Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) (PROCEDURE), Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) (PROCEDURE).
Who is sponsoring clinical trial NCT05409443?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05409443 being conducted?
This trial has 3 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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