Neck PainNCT04152954

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

A study testing Radiofrequency ablation of cervical medial branches in people with Neck Pain and Radiofrequency Ablation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neck Pain, Radiofrequency Ablation, Facet Joint Pain
What is being tested?: Radiofrequency ablation of cervical medial branches
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteCanada
Study dates: 4 Dec 2019to 20 Feb 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre Hospitalier Université de Montréal
Montreal, Quebec

Other trials in Canada

About this study

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.

Conditions: Neck Pain, Radiofrequency Ablation, Facet Joint Pain
Being tested: Radiofrequency ablation of cervical medial branches
Medical subject headings: Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiofrequency ablation of cervical medial branchesDevice
Radiofrequency ablation of cervical medial branches

Study groups in NCT04152954
Study group	Role	What they receive
Traditional cannula	Active comparator	Cervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach. Receives: Device: Radiofrequency ablation of cervical medial branches
Multi-tined cannula	Experimental	Cervical Medial Branch Radiofrequency Neurotomy using a Multi-Tined cannula, the patient lying in lateral decubitus with a lateral approach Receives: Device: Radiofrequency ablation of cervical medial branches

What is being measured

The primary outcome is the main question the study is designed to answer.

Numerical Pain Rating scale for patient's pain during the procedure
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
Measured: 1 day of the intervention

Secondary outcomes (5)

Fluoroscopy time
Calculated time of fluoroscopy in seconds
Measured: 1 day of the intervention
Radiation dosage
Calculated dose of radiation measure by the C-arm
Measured: 1 day of the intervention
time of procedure
Total time of procedure in minutes/seconds
Measured: 1 day of the intervention
Patient pain (Numerical Rating Scale - NRS score)
therapeutic effect on pain Scale is from 0-10, 0/10 is no pain which is better than pain of 10/10
Measured: 0, 3, 6 12 months
Patient function (Neck disability Index - NDI)
therapeutic effect on function scale is from 0-100%, where 0% is better than 100% in terms of the effect of pain on function
Measured: 0, 3, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 201920 Feb 2023

First posted6 Nov 2019
Study start4 Dec 2019
Primary completion16 Feb 2022
Study completion20 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neck PainStudies of the same condition, open and under way.
More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized controlled trial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04152954
Sponsor's protocol ID: 19.101
Status last verified: Mar 2023
First submitted: 1 Nov 2019
Last updated: 13 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
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Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
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All Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain
ClinicalTrials.gov ID: NCT04152954
Acronym / sponsor ID: 19.101
Conditions: Neck Pain, Radiofrequency Ablation, Facet Joint Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
Study start: 4 Dec 2019 (actual)
Primary completion: 16 Feb 2022 (actual)
Study completion: 20 Feb 2023 (actual)
First posted: 6 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: randomized controlled trial

Arm	Type	Receives
Traditional cannula	Active comparator	Device: Radiofrequency ablation of cervical medial branchesCervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach.
Multi-tined cannula	Experimental	Device: Radiofrequency ablation of cervical medial branchesCervical Medial Branch Radiofrequency Neurotomy using a Multi-Tined cannula, the patient lying in lateral decubitus with a lateral approach

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiofrequency ablation of cervical medial branchesRadiofrequency ablation of cervical medial branches	Device	Multi-tined cannula, Traditional cannula

Primary outcome

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

5 secondary outcomes

Fluoroscopy time
Time frame: 1 day of the intervention
Radiation dosage
Time frame: 1 day of the intervention
time of procedure
Time frame: 1 day of the intervention
Patient pain (Numerical Rating Scale - NRS score)
Time frame: 0, 3, 6 12 months
Patient function (Neck disability Index - NDI)
Time frame: 0, 3, 6, 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
Individual participant dataSharing planned: No

Related trials for Neck Pain

Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical Pain Rating scale for patient's pain during the procedure (time frame: 1 day of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152954.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.