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Completed

NCT Number: NCT04152954

Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain

Chronic neck pain is a common disorder for spine specialists. Radiofrequency ablation of medial branches has been proven effective in selected patients for relieving pain. A newer radiofrequency ablation cannula has been developed (multi-tined), allowing perpendicular access. It is proposed as an alternative to the more technically challenging traditional approach. This study aims to compared the technical and clinical aspects of both techniques.

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Key information

Conditions

Neck Pain Facet Joint Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Radiofrequency Ablation Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Université de Montréal

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Cervical neck pain at least 4/10 at rest or with activity
  • Neck pain lasting at least 6 months and refractory to conservative treatments
  • Neck pain is primarily axial (more than upper extremity)
  • Success to medial branch block protocol

Exclusion criteria

  • failure to medial branch block protocol (pain relief less than 75% on 2 occasions)
  • Cervical neck pain less than 4/10
  • Neurological deficits of upper extremity
  • neuropathic pain of upper extremity
  • pregnancy or breastfeeding
  • inflammatory or neoplastic lesion on x-ray
  • neck cortisone injection in last 3 months
  • any medical or psychiatric condition contra-indicated for radiofrequency ablation

Treatment and study plan

Radiofrequency ablation of cervical medial branches

Device

Radiofrequency ablation of cervical medial branches

Primary outcomes

  1. Numerical Pain Rating scale for patient's pain during the procedure

    Time frame: 1 day of the intervention

    pain during radiofrequency procedure will be compared between the 2 groups as a principal hypothesis is that the new multi-tined cannula is better tolerated by patients Scale is from 0-10, 0/10 is no pain which is better than pain of 10/10

Secondary outcomes

  1. Fluoroscopy time

    Time frame: 1 day of the intervention

    Calculated time of fluoroscopy in seconds

  2. Radiation dosage

    Time frame: 1 day of the intervention

    Calculated dose of radiation measure by the C-arm

  3. time of procedure

    Time frame: 1 day of the intervention

    Total time of procedure in minutes/seconds

  4. Patient pain (Numerical Rating Scale - NRS score)

    Time frame: 0, 3, 6 12 months

    therapeutic effect on pain Scale is from 0-10, 0/10 is no pain which is better than pain of 10/10

  5. Patient function (Neck disability Index - NDI)

    Time frame: 0, 3, 6, 12 months

    therapeutic effect on function scale is from 0-100%, where 0% is better than 100% in terms of the effect of pain on function

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 6, 2019
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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