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NCT05424198 · ClinicalTrials.gov registry record · NA
Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula
A NA study of Cervical Pain and Cervical Facet Joint Pain, sponsored by University of Utah.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 3
- Study locations
NCT05424198: Recruiting NA study of Cervical Pain and Cervical Facet Joint Pain, sponsored by University of Utah.
NCT05424198 is a NA study of Cervical Pain and Cervical Facet Joint Pain that is actively recruiting participants, run by University of Utah. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05424198, a NA study of Cervical Pain and Cervical Facet Joint Pain, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 3
- Study locations
Study Summary
Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for cervical facet pain. The efficacy of CMBRFA was proven by studies published in the late 1990's and early 2000's. Patients were selected by a strict, labor-intensive placebo-controlled, diagnostic block protocol and were treated using a conventional monopolar cannula that was positioned parallel to the medial branch, two to three lesions per medial branch nerve and both sagittal and oblique passes. Since the original CMBRFA publications, patient selection for CMBRFA is less strict, and new RFA cannulae have been developed to improve efficiency and safety while maintaining a large ablative lesion. Current clinical patient selection criteria for CMBRFA tend to be more relaxed than described in early research studies. However, subsequent research has shown that when selection criteria are too relaxed, outcomes are poorer. A recent cross-sectional study reported that when CMBRFA is done in patients selected by \>80% pain improvement after dual medial branch blocks, outcomes are similar to patients selected with a stricter selection protocol (100% pain relief) similar to the original CMBRFA studies. Although, the cross-sectional study suggests an appropriate selection criteria, it has not been used in any prospective studies. The Trident multi-tined cannula is a recent technology that produces a large ablative lesion distal to the triple-tined tip. This design allows a perpendicular/lateral approach to CMBRFA and only requires a single lesion at each medial branch. This differs from the conventional cannula, which produces it's most extensive ablative lesion along the cannula with minimal distal projection. As a result, it requires a parallel approach with multiple burn cycles at the same medial branch. The perpendicular approach with Trident and single lesion cycle at each medial branch are appealing for safety purposes and efficiency however, it's efficacy has not been directly compa
Primary Outcome
Proportion of patients with a successful pain response (defined as ≥50% improvement in index pain) to Trident (T-CMBRFA) versus conventional (C-CMBRFA)
Conditions Studied
Interventions
- PROCEDURE Cervical Medial Branch Radiofrequency Ablation
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 | 80 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
What NCT05424198 shows while recruiting
NCT05424198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Cervical Pain appearing as the primary indexed condition, and to 1 intervention - of which Cervical Medial Branch Radiofrequency Ablation is the first listed.
NCT05424198 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05424198 about?
NCT05424198 is a clinical study titled "Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula". Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for cervical facet pain. The efficacy of CMBRFA was proven by studies published in the late 1990's and early 2000's. Patients were selected by a strict, labor-intensive placebo-controlled, diagnostic block protocol and...
What is the current status of trial NCT05424198?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2023-04-26. Estimated completion is 2026-10-31.
What conditions does trial NCT05424198 study?
This clinical trial studies the following conditions: Cervical Pain, Cervical Facet Joint Pain.
What interventions are being tested in trial NCT05424198?
The interventions under investigation include: Cervical Medial Branch Radiofrequency Ablation (PROCEDURE).
Who is sponsoring clinical trial NCT05424198?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05424198 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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