RecruitingNot Applicable

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

Canada, Spain72 participantsStarted 2023-03-10

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Adult patient of either gender aged 18-85 years
✓. Predominant axial (non-radicular) neck pain for at least 3 months
✓. 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation
✓. 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;

Exclusion criteria

✕. Participants with financial incentives or litigation associated with ongoing pain
✕. Inability to complete assessment instruments
✕. Chronic widespread pain
✕. Prior RFN of the CMBN;
✕. Severe mental health issues
✕. Pregnancy or other reason that precludes the use of fluoroscopy
✕. Untreated coagulopathy
✕. Systemic or local infection at the time of screening.

What they're measuring

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

Timeframe: 3 months

Proportion of patients with positive analgesic response

Timeframe: 3 months

Trial details

NCT IDNCT05818774

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Danielle Alvares, PhD

(416) 603-5800 danielle.alvares@uhn.ca

View on ClinicalTrials.gov More Neck Pain trials