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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

Unilateral or bilateral low back pain of at least 4/10 on Numeric Pain Rating Scale (NPRS) present for at least 2 months that has failed to adequately respond to at least 6 weeks of physical therapy and oral pain medication

Must not have

Medical conditions causing significant functional disability (e.g., stroke, COPD)

Chronic widespread pain or somatoform disorder (e.g. fibromyalgia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 have had lower back pain for 2 months, not better after 6 weeks of physical therapy and pain meds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a medical condition like stroke or severe lung disease that greatly limits my daily activities.

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I have been diagnosed with chronic widespread pain or a condition like fibromyalgia.

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My BMI is over 40.

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I can attend all required follow-up appointments.

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I am experiencing worsening muscle weakness or signs of nerve issues in my lower back.

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I have an active inflammatory arthritis condition.

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My main issue is sciatica.

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I receive payment for my pain treatment, like disability benefits.

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I have had surgery to join two or more spine bones in my lower back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

902 Previous Clinical Trials

938,369 Total Patients Enrolled

8 Trials studying Low Back Pain

374 Patients Enrolled for Low Back Pain

Spine Intervention SocietyUNKNOWN

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Low Back Pain

50 Patients Enrolled for Low Back Pain

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.