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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Difference in the mean Numerical Rating Scale (NRS) for pain scores [Срок оценки: at 1, 6 and 12 months]
• Proportion of patients with positive analgesic response [Срок оценки: at 1,3, 6 and 12 months]
• Proportion of patients with reduction in the Neck Disability Index (NDI) score [Срок оценки: at 1, 3, 6, and 12 months]
• Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale [Срок оценки: at 1, 3, 6, and 12 months]
• Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality [Срок оценки: at 1, 3, 6, and 12 months]
• 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. [Срок оценки: at 1, 3, 6, and 12 months]
• Differences in duration of procedure between 2 groups [Срок оценки: day of procedure]
• Differences in discomfort procedure between 2 groups [Срок оценки: day of procedure]
• Differences in radiation dose of procedure between 2 groups [Срок оценки: day of procedure]
• Differences in cost of procedure between 2 groups [Срок оценки: day of procedure]
• Difference in opioid requirements in daily oral morphine equivalents between the groups [Срок оценки: at 3, 6, and 12 months follow-ups after the procedure]
• Difference in average physical activity and sleep duration [Срок оценки: 1 week before the procedure and 1 month after the procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Women's College Hospital — Toronto
• University Health Network (UHN) — Toronto

Испания · 1 центр

• Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, H — Barcelona

Публикации

• MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28. PMID 22458772
• Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302. PMID 8929263
• Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6. doi: 10.1111/j.1526-4637.2005.00047.x. PMID 16083457
• Alomari A, Ferreira-Dos-Santos G, Singh M, Burnham T, Cao X, McCormick Z, Flamer D, Kumar P, Hoydonckx Y, Khan JS, Tumber PS, Alvares D, Bhatia A. End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. Trials. 2023 Nov 11;24(1):721. doi: 10.1186/s13063-023-0 PMID 37951900

Идентификаторы

NCT: NCT05818774 · 22-5634

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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