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NCT Number: NCT05818774

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

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Zygapophyseal Joint Arthritis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network (UHN), Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

f) Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic

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.

Treatment and study plan

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

Procedure

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

Procedure

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 outcomes

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

    Time frame: 3 months

    Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome

  2. Proportion of patients with positive analgesic response

    Time frame: 3 months

    Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline)

Secondary outcomes

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

    Time frame: at 1, 6 and 12 months

    Difference in mean NRS for pain scores at 1, 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome

  2. Proportion of patients with positive analgesic response

    Time frame: at 1,3, 6 and 12 months

    Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) at 1,3, 6 & 12 months

  3. Proportion of patients with reduction in the Neck Disability Index (NDI) score

    Time frame: at 1, 3, 6, and 12 months

    Proportion of patients with ≥10% reduction in the NDI score at 1, 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome

  4. Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale

    Time frame: at 1, 3, 6, and 12 months

    PGIC score is a 7 point scale depicting a patient's subjective rating of overall improvement over time, as proportion of participants reporting improvement in the PGIC scale at 1, 3, 6, and 12 months

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

    Time frame: at 1, 3, 6, and 12 months

    Difference in mean PSQI scores scores at 1, 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality.

  6. 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.

    Time frame: at 1, 3, 6, and 12 months

    Difference in mean EQ-5D-5L scores at 3, 6, and 12 months

  7. Differences in duration of procedure between 2 groups

    Time frame: day of procedure

    Differences in duration of procedure in two groups

  8. Differences in discomfort procedure between 2 groups

    Time frame: day of procedure

    Differences in patient discomfort of procedure

  9. Differences in radiation dose of procedure between 2 groups

    Time frame: day of procedure

    Differences in radiation dose of procedure

  10. Differences in cost of procedure between 2 groups

    Time frame: day of procedure

    Differences in cost of the procedures

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

    Time frame: at 3, 6, and 12 months follow-ups after the procedure

    Difference in opioid requirements in daily oral morphine equivalents in mg averaged over the 1 week before and at 3, 6, and 12 months follow-ups after the procedure

  12. Difference in average physical activity and sleep duration

    Time frame: 1 week before the procedure and 1 month after the procedure

    Difference in average physical activity and sleep duration as measured by wrist-worn actigraphy worn for 1 week before the procedure and 1 month after the procedure

  13. Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure

    Time frame: at 1, 3, 6, and 12 months after the procedures

    Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure in the two groups during and at 1, 3, 6, and 12 months after the procedures

  14. Patient assumption of the group assigned

    Time frame: at 3 months after procedure

    Patient assumption of the group assigned at 3 months after the RFN procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Alvares, PhD

CONTACT

[email protected]

(416) 603-5800 ext. 3517

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: EndPaRL

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 19, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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