Sidekick vs Conventional Cannula in Lumbar Medial Branch Radiofrequency Ablation (SIDE-RFA)

March 11, 2026 updated by: Sami Eksert, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Gulhane Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Cannula
Lumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula.
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
Experimental: Sidekick Cannula
Lumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula.
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: sidekick radiofrecueny cannula
sidekick radiofrequeny cannula designed to preduce a larger lesion during lumbaar brach medial branch radiofrequeny ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

September 24, 2025

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-BADEK-2024-1021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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