Comparing two techniques for treating neck pain with radiofrequency neurotomy
A Prospective, Randomized, Double Blind Clinical Trial Comparing End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves: The EndPaRL Study
This study is testing two different methods of using radiofrequency treatment to see which one helps adults with chronic neck pain from arthritis feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT05818774 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy of two radiofrequency neurotomy techniques for treating chronic neck pain caused by cervical zygapophyseal joint arthritis. Participants will undergo either end-on or parallel lesioning of the cervical medial branch nerves using specialized needles. The study will include adults aged 18-85 who have experienced moderate to severe neck pain for at least three months and have not responded to conservative treatments. The effectiveness of these techniques will be evaluated based on patient-reported pain relief and functional improvement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with chronic neck pain due to cervical zygapophyseal joint arthritis who have not found relief from conservative treatments.
Not a fit: Patients with chronic widespread pain or those who have previously undergone radiofrequency neurotomy of the cervical medial branch nerves may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from chronic neck pain.
How similar studies have performed: Other studies have shown promise with radiofrequency neurotomy techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario and 2 other locations
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
- University Health Network (UHN) — Toronto, Ontario, Canada (Recruiting)
- Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona. — Barcelona, Catalonia, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Anuj Bhatia, MD, PhD — Department of Anesthesia and Pain Management, University Health Network, Toronto
- Study coordinator: Danielle Alvares, PhD
- Email: danielle.alvares@uhn.ca
- Phone: (416) 603-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.