RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-09
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06477094

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Greater than 18 years of age
  2. 2. Presenting with chronic non-radicular lower back pain
  3. 3. Failure of conservative treatment such as physical therapy or NSAID usage
  4. 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
  1. 1. History of known coagulopathy
  2. 2. \> 3 American Society of Anesthesiologists Classification
  3. 3. Pregnancy
  4. 4. Spinal hardware between L3 and S1
  5. 5. Allergies to injection medications
  6. 6. English illiteracy
  7. 7. Pain improvement following physical therapy or NSAID usage
  8. 8. Previous history of attempted lumbar RFA

Contacts and Locations

Study Contact

Jarna Shah, MD
CONTACT
6308648577
jshah2@uams.edu
Edward E Denton, BS
CONTACT
9018323377
edenton@uams.edu

Principal Investigator

Jarna Shah, MD
PRINCIPAL_INVESTIGATOR
University of Arkansas

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Jarna Shah, MD, PRINCIPAL_INVESTIGATOR, University of Arkansas

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 Registration Dates

Study Start Date2024-08-09
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2024-08-09
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • Radiofrequency Ablation
  • Lower Back Pain
  • Lumbar Spondylosis

Additional Relevant MeSH Terms

  • Lumbar Spondylosis