Recruiting

RFA vs. Traditional Electrodes

Sponsor:

University of Arkansas

Code:

NCT06477094

Conditions

Lumbar Spondylosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode

Stryker Venom Radiofrequency Cannula

Study Details

Brief summary:

Spondylosis is an anatomical defect of the small facet joints between the spinal vertebrae often due to load bearing and mechanical wear. It is a major contributor to lower back pain. The current standard of care in patients diagnosed with spondylosis in the lower back is to perform a radiofrequency ablation (RFA) of the lumbar medial branch nerves which carry the pain signals from that region to the brain. RFA accomplishes this by using radio waves transmitted through inserted electrodes. This leads to a temporary lesion or "burn"; stopping the pain signals from being transmitted as as well as changing the pain signals themselves. The electrodes themselves do not heat up but instead cause ions in the surrounding tissue to vibrate and heat up. When performing the procedure at the UAMS pain clinic, one can use the Stryker system with a single electrode end which protrudes out of the cannula or the Stratus Nimbus electrode with two prongs which expand in a "V"; formation along the sides of the cannula. While testing in chicken tissue shows that the latter electrode type produces a larger lesion size, anecdotal evidence suggests that it may lead to longer term pain relief. As such, the choice is currently left up to physician preference as both are FDA approved for use in this condition. This study is trying to assess if the larger lesion size results in a reduction in impairment of activities of daily living due to pain measured by the patient-reported PROMIS (Patient Reported Measurement Information System)-29 questionnaire. The PROMIS-29 is given to all patients who are seen in the UAMS Pain Clinic at initial and follow-up visits. In this study we would like to randomize what electrode and cannula set is used in RFA for patient's who are already going to be receiving the procedure for treatment for their spondylosis. The study team would then compare the PROMIS outcomes between cases that used the Stryker and Stratus Nimbus electrodes at 1,3,6,9 and 12 months. It is hypothesized that the Nimbus electrode will result in a greater reduction and improvement in PROMIS scores for a longer duration than the Stryker electrode.

Conditions

Lumbar Spondylosis

Study ID

NCT06477094

Start date

Aug 9, 2024

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Greater than 18 years of age
2. Presenting with chronic non-radicular lower back pain
3. Failure of conservative treatment such as physical therapy or NSAID usage
4. Diagnosis of lumbar facet mediated lower back pain by a board-certified chronic pain physician via two sets of prognostic lumbar MBBs with 0.5cc of 0.5% bupivacaine with >80% pain relief

Exclusion Criteria:

1. History of known coagulopathy
2. > 3 American Society of Anesthesiologists Classification
3. Pregnancy
4. Spinal hardware between L3 and S1
5. Allergies to injection medications
6. English illiteracy
7. Pain improvement following physical therapy or NSAID usage
8. Previous history of attempted lumbar RFA

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stratus Nimbus

Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stratus Nimbus Electrode.

active comparator: Stryker Venom

Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stryker Venom Cannula.

Interventions

Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode

Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stratus Nimbus Electrode

Stryker Venom Radiofrequency Cannula

Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stryker Venom Cannula

Primary outcome measure

  • PROMIS Outcomes [ Time Frame: 0, 1, 3, 6, 9, and 12 months from procedure date ]

Central Contacts and Locations

Central contacts

Edward E Denton, BS

9018323377edenton@uams.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Aparna Jindal, MD

More Information

Sponsor

University of Arkansas

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Radiofrequency Ablation
  • Lower Back Pain
  • Lumbar Spondylosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-06-08.