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Procedure

Radiofrequency Neurotomy Techniques for Neck Pain (EndPaRL Trial)

N/A

Recruiting

Led By Anuj Bhatia, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Predominant axial (non-radicular) neck pain for at least 3 months

7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3, 6, and 12 months follow-ups after the procedure

Awards & highlights

EndPaRL Trial Summary

This trial compares two techniques to treat neck pain caused by osteoarthritis, to see which is most effective.

Who is the study for?

This trial is for adults aged 18-85 with chronic neck pain due to facet joint arthritis, who haven't found relief from standard treatments. They must have had a positive response to diagnostic nerve blocks and moderate functional impairment. Those with widespread pain, prior similar treatments, severe mental health issues, or conditions preventing fluoroscopy use like pregnancy can't join.Check my eligibility

What is being tested?

The study compares two radiofrequency neurotomy techniques on nerves in the neck for treating chronic neck pain: one using a straight needle (parallel lesioning) and another using a trident needle (end-on lesioning). The goal is to see which method is more effective at reducing pain.See study design

What are the potential side effects?

Potential side effects of the procedures may include temporary increased neck pain, numbness or tingling in the treated area, minor bleeding or bruising at the injection site, and less commonly infection or allergic reaction to anesthetics used.

EndPaRL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had mainly neck pain, not shooting pain, for over 3 months.

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My average neck pain score is 5 or more out of 10.

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My pain causes significant difficulty in my daily activities.

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My neck X-ray shows severe arthritis in the spine joints.

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My condition hasn't improved after 3 months of medication and physical therapy.

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I responded well to two nerve block tests with anesthesia.

EndPaRL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in mean Numerical Rating Scale (NRS) for pain scores

Secondary outcome measures

Difference in mean European Quality of Life (EQ-5D-5L score), a self-assessed, health related, quality of life questionnaire. It ranges from 5 to 25, where higher scores indicate worse outcome.

Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality

Difference in opioid requirements in daily oral morphine equivalents between the groups

+8 more

EndPaRL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RFN of CMBNn with end-on lesioning with multitIned trident cannulaeExperimental Treatment1 Intervention

Intervention type: RF nerve end-on lesioning at 80-850 Celsius for 90 seconds Intervention name: End-on placement of the multitined trident cannulae Intervention description: Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets

Group II: RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)Active Control1 Intervention

Intervention type: RF nerve parallel lesioning at 80-850 Celsius for 90 seconds Intervention name: Straight sharp conventional (SIS's technique) Intervention description: Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,921 Total Patients Enrolled

Anuj Bhatia, MD, PhDPrincipal InvestigatorDepartment of Anesthesia and Pain Management, University Health Network, Toronto

Media Library

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05818774 — N/A

Neck Pain Research Study Groups: RFN of CMBNn with end-on lesioning with multitIned trident cannulae, RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)

Neck Pain Clinical Trial 2023: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae Highlights & Side Effects. Trial Name: NCT05818774 — N/A

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05818774 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile suitable for participation in this medical research program?

"This research is selecting 72 patients who suffer from neck pain and are between 18 to 85 years of age."

Answered by AI

Are individuals aged 45 or above eligible to participate in this experiment?

"The parameters for patient inclusion in this clinical trial, as specified by the criteria, are 18 years of age for a minimum and 85 years of age for a maximum."

Answered by AI

Are there any open vacancies for participants in this trial?

"Affirmative, according to the information on clinicaltrials.gov this trial is actively seeking new enrollees. The study was initially posted on March 10th 2023 and has been updated as recently as April 5th 2023. 72 participants are needed from one location for the experiment to be successful."

Answered by AI

How many individuals are enrolled in this clinical research?

"Affirmative, the data on clinicaltrials.gov indicates that this experiment is in search of participants and was initially posted on March 10th 2023, with a most recent revision occurring April 5th 2023. 72 individuals are required from 1 medical centre."

Answered by AI

Recent research and studies

Pain MedicineJournal

Cervical Medial Branch Radiofrequency Neurotomy in New Zealand

MacVicar, John, James M. Borowczyk, Anne M. MacVicar, Brigid M. Loughnan, and Nikolai Bogduk. 2012. “Cervical Medial Branch Radiofrequency Neurotomy in New Zealand”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/j.1526-4637.2012.01351.x.

clinicaltrials.govStudy

End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves

Anuj Bhatia 2023. "End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05818774.

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