Comparing Multi-Tined and Traditional Electrodes for Radiofrequency Ablation in Treating Lumbar Spondylosis to Improve Daily Living Activities and Pain
Led by University of Arkansas · Updated on 2026-06-08
25
Participants Needed
1
Research Sites
60 weeks
Total Duration
AI-Summary
What this Trial Is About
Lumbar spondylosis is a condition affecting the small facet joints in the lower spine, often causing lower back pain due to wear and mechanical stress. This research evaluates two types of electrodes used in radiofrequency ablation RFA to treat lumbar spondylosis. The study compares the Stratus Nimbus multi-tined electrode, which creates a larger lesion, and the traditional Stryker Venom electrode to see if the larger lesion leads to better pain relief and improved daily functioning measured by the PROMIS-29 questionnaire.
Patients diagnosed with lumbar facet-mediated lower back pain who have already undergone two diagnostic medial branch blocks with significant pain relief will be randomly assigned to receive RFA using either the Stratus Nimbus or the Stryker Venom electrode. The procedure uses radio waves to create a lesion that disrupts pain signals in the lumbar medial branch nerves. The study is double-blinded for patients and follows standard care protocols, with the physician aware of the electrode type used.
Participants will complete the PROMIS-29 questionnaire before treatment and at 1, 3, 6, 9, and 12 months after the procedure to assess pain and impairment in daily activities. Researchers will compare these outcomes to baseline scores to evaluate the effects of each electrode type. The study includes ongoing follow-up over one year to monitor response to treatment and gather data to inform future care decisions.
CONDITIONS
Brief Title
RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis
Research Team
E
Edward Denton, MD
E
Edward E Denton, BS
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Multi-Tined Electrode (Stratus Nimbus)
Traditional Cannula (Stryker Venom)
What it is
Radiofrequency ablation of lumbar medial branch nerves using a multi-tined, expandable electrosurgical electrode designed to create larger lesion volumes.
Radiofrequency ablation of lumbar medial branch nerves using a traditional monopolar radiofrequency cannula.
Role in trial
Participants are randomized to RF ablation using the Stratus Nimbus multi-tined electrode.
Participants are randomized to RF ablation using the Stryker Venom traditional cannula.
Primary use
Used for radiofrequency ablation procedures to treat lumbar facet joint-mediated chronic back pain.
Used for radiofrequency ablation procedures to treat lumbar facet joint-mediated chronic back pain.
How it is given or performed
RF ablation is performed on lumbar medial branch nerves using a multi-tined, expandable electrode to create wider ablation fields. Procedure follows the provider's protocol for device placement and lesioning.
RF ablation is performed on lumbar medial branch nerves using a monopolar cannula, following standard technique for placement and lesion creation.
Evidence status
The clinical evidence base for multi-tined RF electrodes in lumbar facet joint pain is limited; randomized trial data comparing multi-tined to monopolar devices are emerging. Systematic reviews and guidelines confirm efficacy of RF ablation in general, but device-level evidence remains under active investigation.
Randomized and guideline-supported evidence confirm efficacy of traditional monopolar RF ablation for lumbar facet joint pain; device-specific comparative data are still developing.
Important limitations
Device-specific complication risks remain under evaluation. Procedure outcomes may be influenced by technique, anatomy, and lesion volume; direct evidence for optimal lesion characteristics with multi-tined electrodes is limited.
Procedure risks include nerve injury, bleeding, local infection, and technical challenges tied to electrode placement; traditional monopolar cannula outcomes are supported, but optimal lesion characteristics may vary.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Greater than 18 years of age
Chronic non-radicular lower back pain
Failure of conservative treatments such as physical therapy or NSAID usage
Diagnosis of lumbar facet-mediated lower back pain confirmed by two diagnostic medial branch blocks with more than 80% pain relief
You will not qualify if you...
History of known coagulopathy
American Society of Anesthesiologists Classification greater than 3
Pregnancy
Presence of spinal hardware between L3 and S1 vertebrae
Allergies to injection medications
Inability to read or understand English
Pain improvement following physical therapy or NSAID usage
Previous lumbar radiofrequency ablation treatment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits for diagnostic medial branch blocks
Treatment
Duration - 1 day
Participants receive radiofrequency ablation of lumbar medial branch nerves with either the Stratus Nimbus Electrode or the Stryker Venom Cannula as determined by randomization.
1 procedure visit (in-person)
Follow-up
Duration - 12 months
Participants are contacted for assessment of response to treatment including completion of the PROMIS-29 questionnaire to evaluate pain and function.
5 follow-up contacts at 1, 3, 6, 9, and 12 months post-procedure
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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