Comparing two types of electrodes for treating lower back pain from lumbar spondylosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting

Study contacts

• Principal investigator: Aparna Jindal, MD — University of Arkansas
• Study coordinator: Edward Denton, MD
• Email: edenton@uams.edu
• Phone: 9018323377

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.