Status:
RECRUITING
Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula
Lead Sponsor:
University of Utah
Conditions:
Cervical Pain
Cervical Facet Joint Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. P...
Detailed Description
According to the National Center for Health Statistics, neck pain is the third most commonly reported musculoskeletal complaint in the United States. Cervical zygapophysial or "facet" joint pain is re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05424198
Start Date
April 26 2023
End Date
October 31 2026
Last Update
July 1 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Utah Farmington Health Center
Farmington, Utah, United States, 84025
2
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
3
University of Utah South Jordan Health Center
South Jordan, Utah, United States, 84009