Comparing a new cannula for treating cervical facet joint pain

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

This study is testing a new type of tool for a procedure that helps relieve chronic neck pain to see if it works better than the standard tool.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Utah (other)
• Drugs / interventions: radiation
• Locations: 3 sites (Farmington, Utah and 2 other locations)
• Trial ID: NCT05424198 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a new multi-tined cannula for cervical medial branch radiofrequency ablation (CMBRFA) compared to a conventional cannula. CMBRFA is a minimally invasive procedure aimed at alleviating cervical facet joint pain by using thermal energy to disrupt pain signals from specific nerves. The study focuses on patients with chronic neck pain who have undergone diagnostic medial branch blocks to confirm their condition. By employing stricter patient selection criteria, the trial aims to improve treatment outcomes and reduce variability in results.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with chronic axial neck pain and a positive response to diagnostic medial branch blocks.

Not a fit: Patients with non-axial neck pain or those who do not respond positively to diagnostic medial branch blocks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and reliable treatment options for patients suffering from cervical facet joint pain.

How similar studies have performed: Previous studies have shown that stricter selection criteria for CMBRFA can lead to improved outcomes, indicating that this approach may build on established findings.

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.

Where this trial is running

Farmington, Utah and 2 other locations

• University of Utah Farmington Health Center — Farmington, Utah, United States (RECRUITING)
• University of Utah Orthopaedic Center — Salt Lake City, Utah, United States (RECRUITING)
• University of Utah South Jordan Health Center — South Jordan, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: PMR Research Group

Conditions: Cervical Pain, Cervical Facet Joint Pain, cervical medial branch radiofrequency ablation, cervical facet joint pain