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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Difference in mean Numerical Rating Scale (NRS) for pain scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae (Procedure)
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
干预措施: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning (Procedure)
结局指标
主要结局
Difference in mean Numerical Rating Scale (NRS) for pain scores
时间窗: 3 months
Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome
Proportion of patients with positive analgesic response
时间窗: 3 months
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline)
次要结局
- Difference in the mean Numerical Rating Scale (NRS) for pain scores(at 1, 6 and 12 months)
- Proportion of patients with positive analgesic response(at 1,3, 6 and 12 months)
- Proportion of patients with reduction in the Neck Disability Index (NDI) score(at 1, 3, 6, and 12 months)
- Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale(at 1, 3, 6, and 12 months)
- Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality(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.(at 1, 3, 6, and 12 months)
- Differences in duration of procedure between 2 groups(day of procedure)
- Differences in discomfort procedure between 2 groups(day of procedure)
- Differences in radiation dose of procedure between 2 groups(day of procedure)
- Differences in cost of procedure between 2 groups(day of procedure)
- Difference in opioid requirements in daily oral morphine equivalents between the groups(at 3, 6, and 12 months follow-ups after the procedure)
- Difference in average physical activity and sleep duration(1 week before the procedure and 1 month after the procedure)
- Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure(at 1, 3, 6, and 12 months after the procedures)
- Patient assumption of the group assigned(at 3 months after procedure)
研究者
Anuj Bhatia
Professor
University Health Network, Toronto