NCT05818774 End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves
| NCT ID | NCT05818774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Neck Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-03-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2023-03-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim of the EndPaRL study is to compare the efficacy and effectiveness of the two techniques utilizing sharp straight conventional radiofrequency needle with a trident needle for radiofrequency neurotomy of Cervical Medial Branch Nerves (CMBNs), in patients presenting with chronic, moderate-to-severe, neck pain due to cervical zygapophyseal joint osteoarthritis, as diagnosed by positive responses to two consecutive diagnostic blocks with local anesthetic of the CMBN.
Eligibility Criteria
Inclusion Criteria: 1. Adult patient of either gender aged 18-85 years 2. Predominant axial (non-radicular) neck pain for at least 3 months 3. 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation 4. Moderate or greater functional impairment due to pain, defined as NDI Questionnaire raw score of 15 out of 50 (≥30% )e Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months; f) Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic Exclusion Criteria: 1. Participants with financial incentives or litigation associated with ongoing pain 2. Inability to complete assessment instruments 3. Chronic widespread pain 4. Prior RFN of the CMBN; 5. Severe mental health issues 6. Pregnancy or other reason that precludes the use of fluoroscopy 7. Untreated coagulopathy 8. Systemic or local infection at the time of screening.
Contact & Investigator
Anuj Bhatia, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Anesthesia and Pain Management, University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT05818774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Neck Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05818774 currently recruiting?
Yes, NCT05818774 is actively recruiting participants. Contact the research team at danielle.alvares@uhn.ca for enrollment information.
Where is the NCT05818774 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada, Barcelona, Spain.
Who is sponsoring the NCT05818774 clinical trial?
NCT05818774 is sponsored by University Health Network, Toronto. The principal investigator is Anuj Bhatia, MD, PhD at Department of Anesthesia and Pain Management, University Health Network, Toronto. The trial plans to enroll 72 participants.