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Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

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ClinicalTrials.gov Identifier: NCT03912519
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Spine Intervention Society
Information provided by (Responsible Party):
Byron Schneider, Vanderbilt University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Back Pain Without Radiation Low Back Pain Lumbar Radiofrequency Neurotomy Procedure: Parallel placement of 16 gauge electrodes Procedure: Perpendicular placement with 22 gauge electrodes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Parallel placement of 16 gauge electrodes
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.
Procedure: Parallel placement of 16 gauge electrodes
Parallel technique

Active Comparator: Perpendicular placement with 22 gauge electrodes
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.
Procedure: Perpendicular placement with 22 gauge electrodes
Perpendicular technique




Primary Outcome Measures :
  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.




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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912519


Contacts
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Contact: Byron Schneider, MD 615-322-0738 byron.j.schneider@vumc.org
Contact: Blake Fechtel, MD MSc 703-647-0143 fechtel.blake@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Byron Schneider, MD    615-322-0738    byron.j.schneider@vumc.org   
Contact: Blake Fechtel, MD MSc    703-647-0143    fechtel.blake@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
Spine Intervention Society
Investigators
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Principal Investigator: Byron Schneider, MD Vanderbilt University Medical Center
Study Director: Blake Fechtel, MD MSc Vanderbilt University Medical Center

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Responsible Party: Byron Schneider, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03912519     History of Changes
Other Study ID Numbers: 190556
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms