Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614793
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2018
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Zack McCormick, University of Utah

Brief Summary:
Chronic, non-neurogenic low back pain (CLBP) is a common condition that affects many individuals across their lives. The lumbar facet joint has been implicated as an important source of CLBP, with a prevalence of 15-45%. Elements of clinical history, physical examination, and imaging (radiographs, standard CT scan, standard MRI sequences) provide poor diagnostic specificity for pain of lumbar zygapophysial joint (Z-joint) origin. Thus, clinicians have traditionally relied upon MBN blocks to confirm or refute this diagnosis. The reference standard for the diagnosis of lumbar Z-joint pain is a positive response to dual comparative MBN blocks, which requires pain reduction of great than or equal to 80% of concordant duration to that expected of two different local anesthetics on independent occasions. Further, dual comparative MBN blocks have a high positive predictive value for determining the clinical outcome of lumbar MBN RFA for the treatment of lumbar Z-joint pain; when patients are appropriately selected using this reference standard and rigorous MBN RFA technique is implemented according to practice guidelines, studies demonstrate excellent clinical outcomes.

Condition or disease Intervention/treatment Phase
Lumbar Facet Syndrome Procedure: Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: Cooled Radiofrequency Ablation Procedure Procedure: Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome
Radio frequency ablation (RFA) is a medical procedure in which heat is generated from high frequency electrical current in order to lesion (burn) nervous tissue.

Active Comparator: Facet Joint Inject Procedure Procedure: Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome
Radio frequency ablation (RFA) is a medical procedure in which heat is generated from high frequency electrical current in order to lesion (burn) nervous tissue.




Primary Outcome Measures :
  1. Determine the proportion of patients with a successful response to lumbar MBN C-RFA versus facet joint injection of corticosteroid. [ Time Frame: 2 years ]
    The primary outcome for the randomized trial is the proportion of responders, defined by a reduction in NPRS score ≥50% at the 3-month follow-up.


Secondary Outcome Measures :
  1. Physical function (ODI and PF CAT) [ Time Frame: 2 years ]
    The ODI and PF CAT are two validated survey-based measures of physical function and how low back pain may affect physical function/functional disability.

  2. Global function (Global-10) [ Time Frame: 2 year ]
    The Global-10 is a validated survey-based assessment tool of global functioning that includes symptoms, function, and health care related quality of life.

  3. Analgesic use (MQS III score) [ Time Frame: 2 year ]
    Evaluate changes in opioid and non-opioid analgesic use in both groups, as assessed by the conversions to daily morphine equivalent use and Medication Quantification Scale III score.

  4. Global impression of change (PGIC) [ Time Frame: 2 year ]
    PGIC survey-based assessment of subjective improvement in overall symptoms. This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status.

  5. Adverse events [ Time Frame: 2 year ]
    Report immediate, short-term, and long-term adverse effects, using a standardized survey that includes a comprehensive query of known adverse events associated with systemic steroid effects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Adult patients aged > 40 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.
  • Axial (non-radicular) back pain for at least 3 months (ie Chronic Low Back Pain), with pain lasting at least half of the days within those 3 months, that did not respond to conventional treatment such as physical therapy, oral analgesic agents, and non-invasive adjunctive treatments. The pain can be unilateral or bilateral. The pain can also include referred lower limb pain.
  • 7-day worst numeric pain rating score (NPRS) for back pain of 5/10 or greater at baseline evaluation.
  • Positive responses to dual comparative diagnostic MBN blocks using 0.5mL of 0.5% bupivacaine and 4% lidocaine, on respective encounters on separate days, at each of the appropriate MBNs. The blocks are administered in a double-blind fashion so that neither the subject nor the independent assessor is aware of the local anesthetic used.

Exclusion Criteria:

  • Focal neurologic signs or symptoms.
  • Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
  • Active systemic or local infections at the site of proposed needle and electrode placement.
  • Coagulopathy or other bleeding disorder.
  • Receipt of remuneration for their pain treatment (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).
  • History of prior spine surgery.
  • Grade 2 Spondylolisthesis at an affected or adjacent level.
  • BMI >35.
  • Incarceration.
  • Cognitive deficit affecting ability to complete the assessment instruments.
  • Inability to read English and complete the assessment instruments.
  • Allergy to local anesthetics.
  • Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
  • Prior lumbar MBN radiofrequency neurotomy.
  • Addictive behavior, severe clinical depression, anxiety, or any mental health condition with psychotic features.
  • Possible pregnancy or other reason that precludes the use of fluoroscopy.
  • Daily chronic opiate use of >50 morphine equivalents.

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): NCT03614793


Locations
Layout table for location information
United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah

Layout table for additonal information
Responsible Party: Zack McCormick, Associate Professor, Spine and Pain Medicine Director, Clinical Spine Research Director, Interventional Spine and Musculoskeletal Medicine Fellowship, Division of Physical Medicine and Rehabilitation University of Utah School of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT03614793    
Other Study ID Numbers: 111315
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Disease
Pathologic Processes