ENROLLING_BY_INVITATION

Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

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Conditions

Back Pain Without RadiationLow Back PainLumbar Radiofrequency Neurotomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-08-21
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT03912519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * at least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints
  4. * 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
  5. * Patient consents to treatment in a shared decision-making process with the treating physician.
  1. * Those whose primary complain is lumbar radiculopathy
  2. * Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
  3. * Those involved in active litigation relevant to their pain.
  4. * Those unable to read English and complete the assessment instruments.
  5. * Those unable to attend follow up appointments
  6. * The patient is incarcerated.
  7. * History of prior lumbar fusion
  8. * Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy
  9. * History of lumbar steroid injection (epidural steroid injection, sacroiliac joint steroid injection, lumbar facet steroid injection) within the prior 3 months.
  10. * Possible pregnancy or other reason that precludes the use of fluoroscopy.
  11. * Allergy to contrast media or local anesthetics.
  12. * BMI\>40.
  13. * Active Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
  14. * Active infection or treatment of infection with antibiotics within the past 7 days.
  15. * Medical conditions causing significant functional disability (e.g., stroke, COPD)
  16. * Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
  17. * Addictive behavior, severe clinical depression, or psychotic features.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-21
Study Completion Date2027-12

Study Record Updates

Study Start Date2019-08-21
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Back Pain Without Radiation
  • Low Back Pain
  • Lumbar Radiofrequency Neurotomy