Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06477094

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

Led by University of Arkansas · Updated on 2025-06-08

25

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older
  • Have chronic lower back pain without leg radiation
  • Have not improved with physical therapy or NSAIDs
  • Diagnosed with lumbar facet-mediated pain confirmed by two diagnostic nerve blocks showing over 80% pain relief
Not Eligible

You will not qualify if you...

  • History of bleeding disorders
  • American Society of Anesthesiologists classification greater than 3
  • Pregnant women
  • Presence of spinal hardware between L3 and S1
  • Allergies to injection medications
  • Unable to read or understand English
  • Pain improved by physical therapy or NSAIDs
  • Previous lumbar radiofrequency ablation treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

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Research Team

J

Jarna Shah, MD

CONTACT

E

Edward E Denton, BS

CONTACT

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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