Recruiting

End-on vs. Parallel

Sponsor:

University Health Network, Toronto

Code:

NCT05818774

Conditions

Neck Pain

Zygapophyseal Joint Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae

Study Details

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.

Conditions

Neck Pain

Zygapophyseal Joint Arthritis

Study ID

NCT05818774

Start date

Mar 10, 2023

Status verified date

Jan, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RFN of CMBNn with end-on lesioning with multitIned trident cannulae

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

active comparator: RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)

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

Interventions

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning

Intervention type: RF nerve lesioning at 80-85 degree 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

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae

Intervention type: RF nerve lesioning 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.

Primary outcome measure

  • Difference in mean Numerical Rating Scale (NRS) for pain scores [ Time Frame: 3 months ]
  • Proportion of patients with positive analgesic response [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Danielle Alvares, PhD

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

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B3

Contacts

Anuj Bhatia

+1(416)603-5800Anuj.Bhatia@uhn.ca

Didem Bozak

+1 (416)-323-6008didem.bozak@wchospital.ca

University Health Network (UHN)

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Danielle Alvares, PhD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Radiofrequency neurotomy
  • Cervical Medial Branch Nerves

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-01-16.