NCT07475689

Sidekick vs Conventional Cannula in Lumbar Medial Branch Radiofrequency Ablation

Clinical Outcomes of Conventional Versus Sidekick Cannulas in Lumbar Medial Branch Radiofrequency Ablation: A Prospective Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Facet Joint Pain; Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Lumbar Medial Branch Radiofrequency Ablation	Lumbar medial branch radiofrequency ablation performed for chronic lumbar facet-mediated pain. The procedure is performed under fluoroscopic guidance .
DRUG	Triamcinolone (20 g)	Triamcinolone acetonide administered after ablation as part of the post-procedural injection mixture.
DRUG	bupivacain 0.5% 2ml	Bupivacaine 0.5% administered after ablation as part of the post-procedural injection mixture.
DEVICE	conventional radiofrequency cannul	standard straight radiofrequency cannula used during lumbar medial branch radiofrequency ablation
DEVICE	sidekick radiofrecueny cannula	sidekick radiofrequeny cannula designed to preduce a larger lesion during lumbaar brach medial branch radiofrequeny ablation

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-01
• Completion: 2025-09-24
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Turkey (Türkiye)