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โ† Trials
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Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula

RecruitingNAAges 18 Years - anyAllUniversity of Utah
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In plain words

What the trial is, and whether it could suit you

Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for cervical facet pain. The efficacy of CMBRFA was proven by studies published in the late 1990's and early 2000's. Patients were selected by a strict, labor-intensive placebo-controlled, diagnostic block protocol and were treated using a conventional monopolar cannula that was positioned parallel to the medial branch, two to three lesions per medial branch nerve and both sagittal and oblique passes. Since the original CMBRFA publications, patient selection for CMBRFA is less strict, and new RFA cannulae have been developed to improve efficiency and safety while maintaining a large ablative lesion. Current clinical patient selection criteria for CMBRFA tend to be more relaxed than described in early research studies. However, subsequent research has shown that when selection criteria are too relaxed, outc

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adult patient aged โ‰ฅ18 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.
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What it tests

  • Cervical Medial Branch Radiofrequency Ablation
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Where

3 sites
University of Utah Farmington Health Center
Farmington, United States
University of Utah Orthopaedic Center
Salt Lake City, United States
University of Utah South Jordan Health Center
South Jordan, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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