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Enrolling by Invitation

NCT Number: NCT03912519

Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Observational studies have shown that lumbar medial branch radiofrequency neurotomy (LMBRFN) can be an effective treatment for z-joint low back pain. Nonetheless, other publications such as the Cochrane collaboration systematic review and the "Minimal Interventional Treatments for Participants with Chronic Low Back Pain" or "MINT" randomized controlled trial conclude that LMBRFN is not efficacious. These discrepancies in the literature may be due to differences in patient selection and procedural technique. This study aims to employ patient selection via dual medial branch block resulting in at least 80% relief on both occasions. Using this rather strict enrollment criteria, the aim of the study is to then compare LMBRFN utilizing 16 gauge needles via the "parallel" approach as endorsed by Spine Intervention Society guidelines to LMBRFN performed with 22 gauge needles and another commonly employed "perpendicular" technique similar to that approach used for medial branch blocks. The primary outcome of the study will be to determine if there is a difference in the percentage of patients with lumbar facet pain who achieve moderate or good response (improvement of Numeric Pain Rating Scale of at least 50% or 80%) or in the duration of effect (median duration of moderate or good response in those with positive outcome) between these two groups.

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Key information

Conditions

Back Pain Without Radiation Back Pain Low Back Pain Lumbar Radiofrequency Neurotomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Parallel placement of 16 gauge electrodes

Procedure

Parallel technique

Perpendicular placement with 22 gauge electrodes

Procedure

Perpendicular technique

Primary outcomes

  1. Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change

    Time frame: Baseline to 12 months

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

  2. Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Numeric Rating Scale of Pain Intensity

    Time frame: Baseline to 12 months

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

  3. Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Pain

    Time frame: Baseline 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

  4. Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Enjoyment

    Time frame: Baseline 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

  5. Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), General Activity

    Time frame: Baseline 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

  6. Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Not Requiring Other Healthcare

    Time frame: Baseline 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).

  7. Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Returning to Work

    Time frame: Baseline 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).

  8. Change in Oswestry Disability Index (ODI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Spine Intervention Society

Registry information

Official study title

Randomized Trial Comparing Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Apr 11, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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