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Procedure

Radiofrequency Neurotomy Techniques for Low Back Pain

N/A
Recruiting
Led By Byron Schneider, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints
Patient consents to treatment in a shared decision-making process with the treating physician.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

Study Summary

This trial is studying two different types of radiofrequency neurotomy to see which is more effective in treating low back pain caused by the lumbar zygapophyseal joints.

Who is the study for?
This trial is for people over 40 with low back pain that hasn't improved after physical therapy and pain meds. They must have had significant relief from two lumbar medial branch blocks, be able to understand English, consent to treatment, and attend follow-ups. It's not for those with certain conditions like lumbar radiculopathy, litigation or compensation cases related to their pain, severe mental health issues, recent infections or injections in the lower back area.Check my eligibility
What is being tested?
The study compares two techniques of radiofrequency neurotomy—a procedure used to reduce chronic low back pain—by using different needle sizes (16 gauge parallel vs. 22 gauge perpendicular) on patients who've responded well to preliminary treatments. The goal is to see which method gives better or longer-lasting pain relief.See study design
What are the potential side effects?
While the description doesn't list specific side effects, procedures involving needles can typically cause temporary discomfort at the injection site, bleeding, infection risk and possibly nerve damage if not performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experienced significant pain relief from two back nerve block procedures.
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I agree to discuss and decide on my treatment with my doctor.
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I have had lower back pain for 2 months, not better after 6 weeks of physical therapy and pain meds.
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I am over 40, understand English, can follow study procedures, and can attend all follow-ups.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Enjoyment
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), General Activity
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change
+5 more

Trial Design

2Treatment groups
Active Control
Group I: Parallel placement of 16 gauge electrodesActive Control1 Intervention
Parallel Group will undergo radiofrequency ablation via the approach described in Spine Intervention Practice Guidelines via 16 gauge electrodes. Specifically, the target nerve will be targeted with a parallel approach so as the electrode lay parallel to the nerves location within the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.
Group II: Perpendicular placement with 22 gauge electrodesActive Control1 Intervention
Perpendicular Group will undergo radiofrequency ablation via the approach described in Spine Intervention Society Practice Guidelines for medial branch blocks, using a 22 gauge electrode. Specifically, the target nerve will be targeted with a perpendicular approach so as the tip of electrode contact the nerve at some point of it course along the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,091 Total Patients Enrolled
Spine Intervention SocietyUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
Byron Schneider, MD1.921 ReviewsPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
1Patient Review
This doctor was more interested in his own appearance and clothing than in listening to me. He prescribed a medication that has well-known constipating side effects, despite my telling him about my history of bowel problems. He also dismissed my husband's serious back problems as unrelated to his neck condition — which led to my husband nearly becoming paralyzed. Do not see this doctor.

Media Library

Parallel placement of 16 gauge electrodes (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03912519 — N/A
Lower Back Pain Research Study Groups: Parallel placement of 16 gauge electrodes, Perpendicular placement with 22 gauge electrodes
Lower Back Pain Clinical Trial 2023: Parallel placement of 16 gauge electrodes Highlights & Side Effects. Trial Name: NCT03912519 — N/A
Parallel placement of 16 gauge electrodes (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03912519 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~33 spots leftby Dec 2025