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

Launched by UNIVERSITY OF UTAH · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for neck pain caused by issues in the cervical facet joints, specifically comparing a new device called the Trident multi-tined cannula to a traditional cannula. The trial aims to see if the Trident cannula can effectively reduce pain and improve function in patients who have already shown some improvement after a diagnostic procedure. Researchers hope that the Trident will not only provide similar results to the conventional method but will also be safer and quicker.

To participate in this study, you need to be an adult aged 18 or older experiencing neck pain for at least three months, with a specific level of pain. You should also have shown a positive response to a diagnostic pain relief test. Participants will undergo the CMBRFA procedure, and will be monitored for their pain relief and ability to perform daily activities over 3, 6, and 12 months. This trial is currently recruiting participants, and it could be a great opportunity for those looking for effective treatment options for cervical pain.

Gender

ALL

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.