Clinical Outcomes of Conventional Versus Sidekick Cannulas in Lumbar Medial Branch Radiofrequency Ablation: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in pain intensity (Numeric Rating Scale)
研究概览
简要总结
Lumbar facet joint-mediated chronic low back pain is a common cause of disability. Radiofrequency ablation (RFA) of the lumbar medial branches is an established interventional pain treatment. Different cannula designs may influence lesion geometry and clinical outcomes.
This prospective randomized study aims to compare the clinical outcomes of conventional cannulas and sidekick cannulas used during lumbar medial branch radiofrequency ablation. Patients with chronic lumbar facet joint pain who meet inclusion criteria will be randomly assigned to receive RFA using either a conventional cannula or a sidekick cannula technique.
The primary objective is to evaluate pain reduction following the procedure. Secondary outcomes include functional improvement and duration of pain relief during follow-up.
详细描述
Chronic low back pain related to lumbar facet joints is a frequent clinical problem in pain medicine. Lumbar medial branch radiofrequency ablation (RFA) is widely used for the treatment of facet-mediated pain when diagnostic blocks are positive.
Cannula design and electrode orientation may affect lesion size and nerve capture during RFA. The sidekick cannula has been developed to optimize lesion orientation relative to the target nerve and potentially improve procedural efficiency and clinical outcomes compared with conventional cannulas.
This prospective randomized clinical study is conducted to compare the effectiveness of conventional cannulas and sidekick cannulas in lumbar medial branch radiofrequency ablation.
Eligible adult patients with chronic lumbar facet joint-mediated pain confirmed by diagnostic medial branch blocks will be enrolled. Participants will be randomly allocated to one of two groups: RFA performed with a conventional cannula or RFA performed with a sidekick cannula.
Pain intensity, functional outcomes, and treatment response will be evaluated during follow-up visits. The results of this study aim to determine whether cannula design influences procedural success and clinical outcomes in lumbar medial branch radiofrequency ablation.
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)
盲法说明
This is a single-blind randomized study. Participants and outcome assessors are blinded to the cannula type used during lumbar medial branch radiofrequency ablation. The physician performing the procedure is aware of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Chronic lumbar facet-mediated low back pain lasting more than 3 months
- •Failure of conservative treatment including physical therapy and medical management
- •Positive diagnostic medial branch block
- •Patients scheduled for lumbar medial branch radiofrequency ablation
排除标准
- •Previous lumbar radiofrequency ablation at the same level
- •Coagulopathy or anticoagulant therapy that cannot be discontinued
- •Local infection at the procedure site
- •Severe spinal deformity or instability
- •Pregnancy
- •Inability to provide informed consent
研究组 & 干预措施
Conventional Cannula
Lumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula.
干预措施: Lumbar Medial Branch Radiofrequency Ablation (Procedure)
Conventional Cannula
Lumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula.
干预措施: Triamcinolone (20 g) (Drug)
Conventional Cannula
Lumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula.
干预措施: bupivacain 0.5% 2ml (Drug)
Conventional Cannula
Lumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula.
干预措施: conventional radiofrequency cannul (Device)
Sidekick Cannula
Lumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula.
干预措施: Lumbar Medial Branch Radiofrequency Ablation (Procedure)
Sidekick Cannula
Lumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula.
干预措施: Triamcinolone (20 g) (Drug)
Sidekick Cannula
Lumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula.
干预措施: bupivacain 0.5% 2ml (Drug)
Sidekick Cannula
Lumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula.
干预措施: sidekick radiofrecueny cannula (Device)
结局指标
主要结局
Change in pain intensity (Numeric Rating Scale)
时间窗: Baseline to 6 months
Change in pain intensity measured by Numeric Rating Scale (NRS) Pain intensity will be measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.
次要结局
- Functional improvement(6 months)
研究者
Sami Eksert
Anesthesiology Specialist
Gulhane Training and Research Hospital