Comparing a new cannula for treating cervical facet joint pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: PMR.Research@hsc.utah.edu
• Phone: 801-587-5432

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.