Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula

NCT ID
NCT05424198
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of Utah
Conditions
Cervical Facet Joint Pain, Cervical Pain

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: The Effectiveness and Procedural Characteristics of the Trident Multi-tined Cannula for Cervical Medial Branch Radiofrequency Ablation Compared to the Conventional Cannula; A Multi-site, Single Blinded, Randomized Controlled Trial

Enrollment: 80 participants (Estimated).

What is being studied

  • Procedure: Cervical Medial Branch Radiofrequency Ablation

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Adult patient aged ≥18 capable of understanding and providing consent in English and capable of complying with the outcome instruments used. 2. Axial (non-radicular) neck pain for at least 3 months. 3. 7-day average numeric pain rating score (NRS) for neck pain of 4/10 or greater at baseline evaluation. 4. \*Positive responses to dual diagnostic MBB blocks using 0.5mL of lidocaine and bupivacaine, on respective encounters on separate days, at each of the appropriate MBBs. * Levels selected for diagnostic procedures will be determined by the treating physician based on the overall clinical picture including the location of pain, pain referral patterns, physical examination and imaging findings. The procedural techniques of all MBB blocks will be performed according to Spine Intervention Society guidelines.(14) A pain diary with appropriate diagnostic categories of relief will be provided (100% relief, 80-99% relief, etc.), will be provided. In order to qualify as a positive block, the subject must experience relief lasting at least one hour with lidocaine and two hours with bupivacaine. Exclusion Criteria: 1. Those receiving remuneration for their pain treatment (e.g. disability, worker's compensation, auto injury in litigation or pending litigation). 2. The patient is incarcerated. 3. Those unable to read English and complete the assessment instruments. 4. Allergy to contrast media or local anesthetics. 5. Chronic widespread pain or somatoform disorder (e.g. fibromyalgia). 6. Prior cervical medial branch radiofrequency neurotomy. 7. Severe clinical depression or psychotic features. 8. Possible pregnancy or other reason that precludes the use of fluoroscopy. 9. Daily chronic opiate use of \>50 morphine equivalents. 10. Presence of pacemaker of neurostimulator. 11. Systemic infection at time of procedure. 12. Uncontrolled bleeding diathesis. 13. Requirement of IV procedural sedation.

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: United States

  • Utah, United States: 3

Sample of listed locations

  • University of Utah Farmington Health Center — Farmington, Utah, 84025, United States — Recruiting
  • University of Utah Orthopaedic Center — Salt Lake City, Utah, 84108, United States — Recruiting
  • University of Utah South Jordan Health Center — South Jordan, Utah, 84009, United States — Recruiting

Study details

Start date
April 26, 2023
Primary completion date
December 31, 2027
Completion date
December 31, 2027
First posted
June 21, 2022

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05424198
Registry last updated
October 2, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT05424198 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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