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NCT03912519

Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

Enrolling by Invitation
NAAges 40+InterventionalTreatment
Vanderbilt University Medical Center
~132 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Parallel placement of 16 gauge electrodesPerpendicular placement with 22 gauge electrodes

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change
Measured over Baseline to 12 months
+7 more outcomes measured

Conditions

Back Pain Without Radiation
Low Back Pain
Lumbar Radiofrequency Neurotomy

Explore related trials

Lower Back Pain

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Byron Schneider, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
  • Blake Fechtel, MD MSc · STUDY_DIRECTOR · Vanderbilt University Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

aged \> 40, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
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
at least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints
beyond the above stated criteria, the decision to initiate the process of a first medial branch block is based on clinical decision making of the treating physician
Patient consents to treatment in a shared decision-making process with the treating physician.

Exclusion

Those whose primary complain is lumbar radiculopathy
Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
Those involved in active litigation relevant to their pain.
Those unable to read English and complete the assessment instruments.
Those unable to attend follow up appointments
The patient is incarcerated.
History of prior lumbar fusion
Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy
History of lumbar steroid injection (epidural steroid injection, sacroiliac joint steroid injection, lumbar facet steroid injection) within the prior 3 months.
Possible pregnancy or other reason that precludes the use of fluoroscopy.
Allergy to contrast media or local anesthetics.
BMI\>40.
Active Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
Active infection or treatment of infection with antibiotics within the past 7 days.
Medical conditions causing significant functional disability (e.g., stroke, COPD)
Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
Addictive behavior, severe clinical depression, or psychotic features.

What this trial measures

  • Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of ChangeBaseline to 12 months

    Global Impression of Change; Range 0-7 0 = Very much improved 7 = Very much worse

  • Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Numeric Rating Scale of Pain IntensityBaseline to 12 months

    Numeric Rating Scale of Pain Intensity; Range 0-10 0 = No pain 10 = Pain as bad as you can imagine

  • Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), PainBaseline to 12 months

    Pain sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = No Pain 10 = Pain as bad as you can image

  • Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), EnjoymentBaseline to 12 months

    Enjoyment sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes

  • Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), General ActivityBaseline to 12 months

    General Activity sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes

  • Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Not Requiring Other HealthcareBaseline to 12 months

    Categorical Outcome; ideal would be that patients no longer require other care for the condition for which they were treated. So, the scoring is simply absolute. The instrument is neither designed nor intended for more granular analysis, on the grounds that partial reduction in doses required, but nevertheless continuation of other treatment, falls short of indicating a worthwhile, successful outcome (PubMed Identifier: 25312899).

  • Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Returning to WorkBaseline to 12 months

    Categorical outcome; it is very relevant if return to work is achieved. Failure to return to work is too vexatious an issue, with so many determinants that it is neither efficient nor effective to bother trying to record them (Reference PMID: 25312899).

  • Change in Oswestry Disability Index (ODI)Baseline to 12 months

    The questionnaire is designed to give information on how pain is affecting the ability to manage everyday life. The range of scores is 0-100%. 0-20%: "minimal disability": The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21-40%: "moderate disability": The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41-60%: "severe disability": Pain remains the main problem in this group but activities of daily living are affected. 61-80%: "crippled": Back pain impinges on all aspects of the patient's life. 81-100%: These patients are either bed-bound or exaggerating their symptoms.