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Completed

NCT Number: NCT07475689

Sidekick vs Conventional Cannula in Lumbar Medial Branch Radiofrequency Ablation

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.

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Key information

Conditions

Facet Joint Pain; Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Training and Research Hospital, Department of Anesthesiology and Reanimation

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Lumbar Medial Branch Radiofrequency Ablation

Procedure

Lumbar medial branch radiofrequency ablation performed for chronic lumbar facet-mediated pain. The procedure is performed under fluoroscopic guidance .

Triamcinolone (20 g)

Drug

Triamcinolone acetonide administered after ablation as part of the post-procedural injection mixture.

bupivacain 0.5% 2ml

Drug

Bupivacaine 0.5% administered after ablation as part of the post-procedural injection mixture.

conventional radiofrequency cannul

Device

standard straight radiofrequency cannula used during lumbar medial branch radiofrequency ablation

sidekick radiofrecueny cannula

Device

sidekick radiofrequeny cannula designed to preduce a larger lesion during lumbaar brach medial branch radiofrequeny ablation

Primary outcomes

  1. Change in pain intensity (Numeric Rating Scale)

    Time frame: 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.

Secondary outcomes

  1. Functional improvement

    Time frame: 6 months

    Functional status will be assessed using the Modified Oswestry Disability Index (MODI), a validated questionnaire evaluating disability related to low back pain. The MODI consists of 10 items with a total score ranging from 0 to 100, where higher scores indicate greater disability and worse functional status. Changes in MODI scores will be evaluated during follow-up after lumbar medial branch radiofrequency ablation using conventional or sidekick cannulas.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Registry information

Official study title

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

Acronym: SIDE-RFA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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