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Cannula multistrato Trident per MBRFA cervicale rispetto alla cannula convenzionale

29 settembre 2026 aggiornato da: Allison Glinka Przybysz, University of Utah

L'efficacia e le caratteristiche procedurali della cannula a più punte Trident per l'ablazione con radiofrequenza del ramo cervicale mediale rispetto alla cannula convenzionale; Uno studio multi-sito, in singolo cieco, controllato randomizzato

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. 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. 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. 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.

Panoramica dello studio

Descrizione dettagliata

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 responsible for at least 25% of patients with chronic neck pain and is higher in patients with neck pain after a whiplash injury. Individuals with verified facetogenic pain or cervicogenic headaches can be treated with cervical medial branch radiofrequency ablation (CMBRFA). CMBRFA is a minimally invasive percutaneous procedure that utilizes thermal energy to coagulate nerves from the facet joints, and thereby interrupt the nociceptive pain signals. The targeted nociceptive nerves are the medial branches of the cervical dorsal rami and the third occipital nerve.

The gold standard method of facet pain diagnosis is anesthetizing the medial branches that innervate the involved facet joint and subsequently evaluating the significance of symptom improvement; this process is known as a medial branch block (MBB). There is significant practice variability in what is considered a "positive" MBB. A single cervical MBB with 100% symptom improvement has a false positive rate of 27-60%. The false positive rate decreases with stricter selection criteria. The efficacy of CMBRFA was established in the late 1990's and early 2000's when using a strict selection criteria; 100% symptom improvement with concordant dual medial branch block ± placebo-control block.

In 1996, Lord et al. published in New England Journal of Medicine research showing that when the rigorous diagnostic criteria were adhered to, 63% (CI 95%: 57-69%) and 38% (CI 95%:32-44%) of patients were pain free at 6 and 12 months following CMFRFA. Though comparative dual MBB ± placebo with 100% symptom improvement reduces false positive rates, it is time consuming and expensive, exposes patients to extra radiation and procedural risk, is not required by insurance, and is not the Spine Interventional Society (SIS) recommended gold standard for patient selection for facetogenic pain in the lumbar spine. Currently insurance requires ≥80% symptom improvement with dual facet block. These insurance requirements are consistent with the research supported SIS guidelines for the diagnosis of lumbar facetogenic pain and such practical patient selection criteria are commonly utilized in clinical practice. A recent cross-sectional study reported that when CMBRFA is performed on patients selected by >80% symptom improvement after dual medial branch block, outcomes are similar to patients selected with a stricter selection protocol similar to the original CMBRFA studies however, this needs to be validated in prospective studies.

In early explanatory studies, providers used a conventional monopolar cannulae to ablate targeted medial branch nerves. C-CMBRFA cannula produce the largest lesions along the shaft of the cannula with minimal extension distal to the tip. To increase the likelihood of medial branch ablation the conventional cannula is placed parallel to the targeted medial branch in a posterior to anterior approach with sagittal and oblique passes, and 2-3 lesions per medial branch. Disadvantages to the conventional technique is the procedural time needed for multiple passes and burns and the risk of ventral advancement of the cannula towards vital neurovascular structures. Since the original explanatory C-CMBRFA studies, there have been technologic advances in RFA cannulae in an effort to improve safety and efficiency of CMBRFA.

The Trident multitined cannula was designed to allow a perpendicular/lateral approach to the medial branch nerves. Such approach results in point contact against bone, prevents unintended advancement towards neurovascular structures, and as a result adds to the safety of the procedure. There is also reported efficiency during Trident RFA since only 1 pass and a single lesion at each medial branch is required. A single burn cycle at each site is a possibility because of the unique lesion shape and size. The Trident cannula most commonly used for CMBRFA is 18-gauge and has a 5 mm exposed tip. Once the cannula tip is placed at the target location, 3 tines are deployed anterior and laterally from the cannula tip in an equilateral triangle configuration. Computer simulation calculations predict that a two-minute lesion at 75°C would result in thermal coagulation in an area measuring 7.6 mm wide by 7.6 mm length in the axial plane (at the periosteal surface) and 9.1 mm in height in the sagittal plane (soft tissue lesion) [data provided by Diros Technology Inc.]. These values are comparable to the findings of Finlayson et al who compared thermal lesions morphology of 2 multitined cannulae and a conventional monopolar cannula in an ex vivo model. In the axial plane, with the Trident cannula perpendicular to the periosteum, the mean lesion width and length were 7.3 x 8.8 mm respectively. In the sagittal plane, the mean lesion height was 7.3 mm. Considering that the mean distance between the medial branch nerve at the waist of the articular pillar, and the tip of the superior facet has been documented to be between 7.1-7.4 mm for C3 through C6 and 5.5 mm for C7, a single Trident lesion placed at the waist of the lateral mass should cover approximately one half of the periosteal surface. This should be adequate to accommodate medial branch nerve anatomical variation. Ultimately, the Trident cannula results in an approach that may be technically easier, quicker, safer, more comfortable and as effective as the traditional parallel/posterior approach however, there are no studies comparing Trident to conventional cannula during CMBRFA.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Utah
      • Farmington, Utah, Stati Uniti, 84025
      • Salt Lake City, Utah, Stati Uniti, 84108
      • South Jordan, Utah, Stati Uniti, 84009

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Trident 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).

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.

Comparatore attivo: Conventional Cervical Medial Branch Radiofrequency Ablation

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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post Procedure Pain Response
Lasso di tempo: 3, 6, and 12 months

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post Procedure Disability Response
Lasso di tempo: 3, 6, and 12 months

The proportion of patients with a successful functional response (defined as ≥ 10% reduction on neck disability index [NDI]) to T-CMBRFA versus C-CMBRFA

3, 6, and 12 months
Post Procedure Patient Impression of Change
Lasso di tempo: 3, 6, and 12 months

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

3, 6, and 12 months
Procedural Radiation Dose
Lasso di tempo: After procedure

Differences in procedural patient radiation dose during T-CMBRFA versus C-CMBRFA.

After procedure
Procedure discomfort
Lasso di tempo: After procedure

Differences in procedural patient discomfort during T-CMBRFA versus C-CMBRFA.

After procedure
Procedure time
Lasso di tempo: After procedure

Differences in procedural time during T-CMBRFA versus C-CMBRFA.

After procedure

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 aprile 2023

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

28 dicembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

14 giugno 2022

Primo Inserito (Effettivo)

21 giugno 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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