Facet Joint Pain; Low Back PainSIDE-RFANCT07475689
Sidekick vs Conventional Cannula in Lumbar Medial Branch Radiofrequency Ablation
A study testing Lumbar Medial Branch Radiofrequency Ablation, Triamcinolone (20 g) and bupivacain 0.5% 2ml in people with Facet Joint Pain; Low Back Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet Joint Pain; Low Back Pain
- What is being tested?
- Lumbar Medial Branch Radiofrequency Ablation, Triamcinolone (20 g) and bupivacain 0.5% 2ml
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital, Department of Anesthesiology and Reanimation
Ankara, 06010
About this study
Official title: 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.
Read the 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
- Being tested
- Lumbar Medial Branch Radiofrequency Ablation, Triamcinolone (20 g), bupivacain 0.5% 2ml, conventional radiofrequency cannul, sidekick radiofrecueny cannula
- Keywords
- Back pain, Facet joint pain, Sidekick cannula, Chronic back pain
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Medial Branch Radiofrequency AblationProcedure or surgery
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% 2mlDrug
Bupivacaine 0.5% administered after ablation as part of the post-procedural injection mixture.
conventional radiofrequency cannulDevice
standard straight radiofrequency cannula used during lumbar medial branch radiofrequency ablation
sidekick radiofrecueny cannulaDevice
sidekick radiofrequeny cannula designed to preduce a larger lesion during lumbaar brach medial branch radiofrequeny ablation
| Study group | Role | What they receive |
|---|---|---|
| Conventional Cannula | Active comparator | Lumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula. Receives: Procedure: Lumbar Medial Branch Radiofrequency Ablation; Drug: Triamcinolone (20 g); Drug: bupivacain 0.5% 2ml; Device: conventional radiofrequency cannul |
| Sidekick Cannula | Experimental | Lumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula. Receives: Procedure: Lumbar Medial Branch Radiofrequency Ablation; Drug: Triamcinolone (20 g); Drug: bupivacain 0.5% 2ml; Device: sidekick radiofrecueny cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity (Numeric Rating Scale)
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.
Measured: Baseline to 6 months
Secondary outcomes (1)
Functional improvement
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2024
- Primary completion1 Aug 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint Pain; Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Eksert, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475689
- Sponsor's protocol ID
- AEŞH-BADEK-2024-1021
- Acronym
- SIDE-RFA
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Conventional Versus Sidekick Cannulas in Lumbar Medial Branch Radiofrequency Ablation: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07475689
- Acronym / sponsor ID
- SIDE-RFA / AEŞH-BADEK-2024-1021
- Conditions
- Facet Joint Pain; Low Back Pain
- Keywords
- Back pain, Facet joint pain, Sidekick cannula, Chronic back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Cannula | Active comparator | Procedure: Lumbar Medial Branch Radiofrequency Ablation, Drug: Triamcinolone (20 g), Drug: bupivacain 0.5% 2ml, Device: conventional radiofrequency cannulLumbar medial branch radiofrequency ablation performed using a conventional radiofrequency cannula. |
| Sidekick Cannula | Experimental | Procedure: Lumbar Medial Branch Radiofrequency Ablation, Drug: Triamcinolone (20 g), Drug: bupivacain 0.5% 2ml, Device: sidekick radiofrecueny cannulaLumbar medial branch radiofrequency ablation performed using a sidekick radiofrequency cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Medial Branch Radiofrequency AblationLumbar medial branch radiofrequency ablation performed for chronic lumbar facet-mediated pain. The procedure is performed under fluoroscopic guidance . | Procedure or surgery | Conventional Cannula, Sidekick Cannula |
| Triamcinolone (20 g)Triamcinolone acetonide administered after ablation as part of the post-procedural injection mixture. | Drug | Conventional Cannula, Sidekick Cannula |
| bupivacain 0.5% 2mlBupivacaine 0.5% administered after ablation as part of the post-procedural injection mixture. | Drug | Conventional Cannula, Sidekick Cannula |
| conventional radiofrequency cannulstandard straight radiofrequency cannula used during lumbar medial branch radiofrequency ablation | Device | Conventional Cannula |
| sidekick radiofrecueny cannulasidekick radiofrequeny cannula designed to preduce a larger lesion during lumbaar brach medial branch radiofrequeny ablation | Device | Sidekick Cannula |
Primary outcome
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.
1 secondary outcome
Functional improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Facet Joint Pain; Low Back Pain
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
RecruitingObservational study
Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study
Degenerative Arthropathy of Lumbar Spinal Facet Joint
RecruitingObservational study
Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
Chronic Low Back Pain, Lumbar Facet Joint Degeneration
RecruitingObservational study
Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease
Lower Back Pain of Disc Origin, Joint Facet Syndrome
Not yet recruiting
Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain
Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Medial Branch Radiofrequency Ablation, Triamcinolone (20 g) and bupivacain 0.5% 2ml in people with Facet Joint Pain; Low Back Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (Numeric Rating Scale) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.