RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis

June 4, 2026 updated by: University of Arkansas

Efficacy of Radiofrequency Ablation Using Multi-Tined Electrodes vs. Traditional Electrodes for Treatment of Lumbar Spondylosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single center double-blinded prospective randomized clinical trial. Patients will be recruited from the pool of patients seen by the Principal Investigators (PIs) and collaborating physicians in the UAMS pain management clinic through the Department of Anesthesiology. Candidacy for RFA is determined by the standard of care which includes diagnosis of axial low back pain without lower extremity radiation or other primary pain generators. These patients should not have had previous RFA's in the lumbar region before. These patients should receive greater than 80% pain relief following two diagnostic MBBs completed at separate times. In routine care, physicians discuss with patients the risks and benefits associated with the RFA procedure. In order to establish a baseline level of pain, disability, and impairment of daily living, patients are routinely asked to complete the PROMIS-29 questionnaire to the best of their ability. Once patients receive their second MBB they are to return 2 to 4 weeks later for RFA should they meet the necessary 80% pain relief. At the time of the procedure, a simple randomization performed by a staff member not involved in the patient's care, will be used to determine if the patient's procedure will involve the use of the Stratus Nimbus or the Stryker Venom electrode and cannula set. The provider performing the procedure will be made aware of which electrode is to be used. However, patients will be blinded to the group to which they were randomized. Patients will continue with conventional RFA as per standard of care. Patients will then be contacted at 1,3,6, 9, and 12 months for assessment of response to intervention including the PROMIS-29 questionnaire. Scores are then compared to those taken at baseline to determine efficacy of treatment and inform future care.

Study Type

Interventional

Enrollment (Estimated)

25

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Sub-Investigator:
          • Edward Denton, BS
        • Sub-Investigator:
          • Johnathan Goree, MD
        • Sub-Investigator:
          • Gregory L Smith, MD
        • Sub-Investigator:
          • Christopher Maranto, MD
        • Sub-Investigator:
          • Ahad Nadeem, BS
        • Contact:
        • Principal Investigator:
          • Aparna Jindal, MD
        • Sub-Investigator:
          • Attwal Sawan, BS

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:

  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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stratus Nimbus
Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stratus Nimbus Electrode.
Device: Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode
Radiofrequency Ablation of Lumbar Medial Branch Nerves using 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.
Device: Stryker Venom Radiofrequency Cannula
Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stryker Venom Cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Outcomes
Time Frame: 0, 1, 3, 6, 9, and 12 months from procedure date
The PROMIS (Patient Reported Outcomes Measurement Information System) outcomes as reported by the PROMIS-29 questionnaire serve as an indicator for pain severity and impairment of activities of daily living. The PROMIS-29 questionnaire which assess 7 heath domains which include 4 survey items with scores ranging from 0 being no impairment and 5 being the most severe impairment. The questionnaire also assess the patient's pain on a numerical scale from 0 being no pain and 10 being the worst pain experienced by the patient. Both components are then used to assess impairment of daily activities using composite T-scores which are calculated from the raw data. T-Scores between 40-45 is considered mild impairment, 30-40 is considered moderate impairment, and less then 30 is considered severe impairment.
0, 1, 3, 6, 9, and 12 months from procedure date

Collaborators and Investigators

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

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Aparna Jindal, MD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 9, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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.

Clinical Trials on Lumbar Spondylosis

Clinical Trials on Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe