Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula
Cervical Pain, Cervical Facet Joint Pain
About this trial
This is an interventional treatment trial for Cervical Pain focused on measuring cervical medial branch radiofrequency ablation, cervical facet joint pain
Eligibility Criteria
Inclusion Criteria:
- Adult patient aged ≥18 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.
- Axial (non-radicular) neck pain for at least 3 months.
- 7-day average numeric pain rating score (NRS) for neck pain of 4/10 or greater at baseline evaluation.
*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:
- Those receiving remuneration for their pain treatment (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).
- The patient is incarcerated.
- Those unable to read English and complete the assessment instruments.
- Allergy to contrast media or local anesthetics.
- Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
- Prior cervical medial branch radiofrequency neurotomy.
- Severe clinical depression or psychotic features.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Daily chronic opiate use of >50 morphine equivalents.
- Presence of pacemaker of neurostimulator.
- Systemic infection at time of procedure.
- Uncontrolled bleeding diathesis.
- Requirement of IV procedural sedation.
Sites / Locations
- University of Utah Farmington Health CenterRecruiting
- University of Utah Orthopaedic CenterRecruiting
- University of Utah South Jordan Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Trident Cervical Medial Branch Radiofrequency Ablation
Conventional Cervical Medial Branch Radiofrequency Ablation
During this procedure a 50 mm or 100 mm long (dependent on body habitus), 18-gauge insulated cannula with a 5 mm active tip will be placed perpendicularly at targeted medial branches (the nerves carrying pain signals from the facet joints).
During this procedure a 50 mm or 100 mm long (dependent on body habitus), 18-gauge conventional cannula with a straight 5 mm active tip will be placed parallel and oblique to the targeted medial branch branches (the nerves carrying pain signals from the facet joints). At each location, one lesion will be made to accommodate anatomic variation.