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

NCT05424198 | Recruiting FDA Device

• 1 other identifier: IRB 143800
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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. 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, outcomes are poorer. A recent cross-sectional study reported that when CMBRFA is done in patients selected by \>80% pain improvement after dual medial branch blocks, outcomes are similar to patients selected with a stricter selection protocol (100% pain relief) similar to the original CMBRFA studies. Although, the cross-sectional study suggests an appropriate selection criteria, it has not been used in any prospective studies. The Trident multi-tined cannula is a recent technology that produces a large ablative lesion distal to the triple-tined tip. This design allows a perpendicular/lateral approach to CMBRFA and only requires a single lesion at each medial branch. This differs from the conventional cannula, which produces it's most extensive ablative lesion along the cannula with minimal distal projection. As a result, it requires a parallel approach with multiple burn cycles at the same medial branch. The perpendicular approach with Trident and single lesion cycle at each medial branch are appealing for safety purposes and efficiency however, it's efficacy has not been directly compared to the standard conventional cannula. Problem: There are no randomized controlled trials comparing novel technologies like Trident cannula to the previously studied conventional cannula in patients selected with a more practical selection criteria. Purpose: To compared procedural characteristics, pain, and disability outcomes of CMBRFA using either a Trident or conventional cannula in patients with confirmed facet mediated pain (defined by ≥80% symptom reduction after dual medial branch block). Central Hypothesis: Trident cannula during CMBRFA will result in noninferior improvements in pain and function compared to conventional cannula but will significantly reduce procedural discomfort, time and radiation exposure. Specific Aims:

1. 1.Determine the proportion of patients with a successful pain response (defined as ≥50% improvement in index pain) to Trident (T-CMBRFA) versus conventional (C-CMBRFA) at 3, 6, and 12 months.
2. 2.Determine the proportion of patients with a successful functional response (defined as ≥10% reduction on neck disability index \[NDI\]) to T-CMBRFA versus C-CMBRFA at 3, 6, and 12 months.
3. 3.Determine the proportion of patients with a successful perception of improvement (defined as a score ≥6 on the Patient Global Impression of Change \[PGIC\]) to T-CMBRFA versus C-CMBRFA at 3, 6, and 12 months.

Conditions

Cervical Pain; Cervical Facet Joint Pain

Keywords

cervical medial branch radiofrequency ablation; cervical facet joint pain

Outcome Measures

Primary Outcomes (1)

• Post Procedure Pain Response

  Proportion of patients with a successful pain response (defined as ≥50% improvement in index pain) to Trident (T-CMBRFA) versus conventional (C-CMBRFA)

  3, 6, and 12 months

Secondary Outcomes (5)

• Post Procedure Disability Response

  3, 6, and 12 months

• Post Procedure Patient Impression of Change

  3, 6, and 12 months

• Procedural Radiation Dose

  After procedure

• Procedure discomfort

  After procedure

• Procedure time

  After procedure

Study Arms (2)

Trident Cervical Medial Branch Radiofrequency Ablation

ACTIVE COMPARATOR

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).

Procedure: Cervical Medial Branch Radiofrequency Ablation

Conventional Cervical Medial Branch Radiofrequency Ablation

ACTIVE COMPARATOR

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.

Procedure: Cervical Medial Branch Radiofrequency Ablation

Interventions

Cervical Medial Branch Radiofrequency Ablation PROCEDURE

The skin and superficial tissues will be anesthetized at each site with 1-2 mL of lidocaine. Prior to the ablation up to 2 mL of lidocaine may be used at each site to ensure adequate pain control during the ablation. Once in position, a radiofrequency ablation lesion will be made using a 30 second ramp-up time to a maximum temperature of 80 °C, followed by an additional 90 seconds at maximum temperature.

Conventional Cervical Medial Branch Radiofrequency Ablation; Trident Cervical Medial Branch Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (3)

University of Utah Farmington Health Center

Farmington, Utah, 84025, United States

RECRUITING

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Utah South Jordan Health Center

South Jordan, Utah, 84009, United States

RECRUITING

Related Publications (18)

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Related Links

• The burden of musculoskeletal diseases in the United States.
• The Prevalence of Cervical Zygapophyseal Joint Pain; A First Approximation.
• The Prevalence of Chronic Cervical Zygapophysial Joint Pain After Whiplash.
• False-Positive Rates of Cervical Zygapophysial Joint Blocks.
• Medial branch blocks are specific for the diagnosis of cervical zygapophyseal joint pain.
• Radiofrequency neurotomy for the treatment of third occipital headache.
• Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.
• Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

PMR Research Group

CONTACT

801-587-5432; PMR.Research@hsc.utah.edu

Taylor Burnham, DO

CONTACT

801-587-5488; taylor.burnham@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized to one of two standard of care procedures: trident cannula cervical medial branch radiofrequency ablation or conventional cervical medial branch radiofrequency ablation. Participants will be blinded to which group they are randomized to. Outcomes will be collected by a blinded third party.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator and Assistant Professor

Model Details: To compare procedural characteristics, pain, and disability outcomes of cervical medial branch radiofrequency ablation (CMBRFA) using either a Trident or conventional cannula in patients with confirmed facet mediated pain (defined by ≥80% symptom reduction after dual medial branch block).

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: June 21, 2022
• Study Start: April 26, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 1, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)