Comparing two types of electrodes for treating lower back pain from lumbar spondylosis
Efficacy of Radiofrequency Ablation Using Multi-Tined Electrodes vs. Traditional Electrodes for Treatment of Lumbar Spondylosis
NA · University of Arkansas · NCT06477094
This study is testing two different types of electrodes to see which one helps people with lower back pain from lumbar spondylosis feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arkansas (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT06477094 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two different radiofrequency ablation (RFA) techniques for patients suffering from lumbar spondylosis, a common cause of lower back pain. Participants will be randomly assigned to receive treatment using either the Stratus Nimbus multi-tined electrode or the Stryker Venom electrode. The study aims to assess pain relief and functional improvement after the procedures, with patients undergoing a thorough evaluation to ensure they meet the necessary criteria for candidacy. The trial is conducted at the University of Arkansas for Medical Sciences and employs a double-blinded approach to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic non-radicular lower back pain who have not responded to conservative treatments.
Not a fit: Patients with a history of coagulopathy, significant comorbidities, or previous lumbar RFA attempts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from chronic lower back pain due to lumbar spondylosis.
How similar studies have performed: Previous studies have shown promising results with radiofrequency ablation techniques, but this specific comparison of electrode types is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Little Rock, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (RECRUITING)
Study contacts
- Principal investigator: Jarna Shah, MD — University of Arkansas
- Study coordinator: Jarna Shah, MD
- Email: jshah2@uams.edu
- Phone: 6308648577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Spondylosis, Radiofrequency Ablation, Lower Back Pain