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

NCT03614793 | Completed Results

• 1 other identifier: 111315
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Facet Syndrome

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  This is a scale from 0 to 10, with 0 being no back pain at all and 10 being the worst back pain imaginable The primary outcome for this study was the proportion of participants within each group (C-RFA and FJI) who experienced a greater than or equal to 50% reduction in NPRS score at 3 months. Participants were asked to rate their pain over the past 7 days on a scale from 0 to 10.

  3 Months

Secondary Outcomes (5)

• Decrease in Oswestry Disability Index (ODI) Score

  6 Months

• Patient Global Impression of Change (PGIC)

  6 Months

• Numeric Pain Rating Scale (NPRS) Point Change

  6 Months

• Global Impression of Change (PGIC)

  2 year

• Adverse Events

  2 year

Study Arms (2)

Cooled Radiofrequency Ablation Procedure

ACTIVE COMPARATOR

Cooled Radiofrequency Ablation (C-RFA) Procedure: This is performed under image (x-ray) guidance for the accuracy of needle placement. A Cooled Radiofrequency electrode will be placed at the surface of the facet joint. After appropriate electrode positioning, a local anesthetic (lidocaine) will be injected through the needle to take away pain during the ablation. Once the procedure is completed, all needles will be removed and additional local anesthetic (bupivacaine) will be injected. No corticosteroids will be injected.

Procedure: Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome

Facet Joint Inject Procedure

ACTIVE COMPARATOR

Facet joint injection (FJI) Procedure: This is performed under image guidance (x-ray) for the accuracy of needle placement. A needle will be carefully placed in the facet joint(s) causing pain. Contrast will be injected to confirm the ideal needle placement. The injection will then be completed with triamcinolone (steroid) and lidocaine. This technique will be repeated for each facet joint injected. For bilateral low back pain, a maximum of 4 facet joints (two on each side) will be treated. For unilateral low back pain, up to 3 facet joints will be treated.

Procedure: Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome

Interventions

Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome PROCEDURE

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.

Cooled Radiofrequency Ablation Procedure; Facet Joint Inject Procedure

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged \> 21 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.
• 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.

You may not qualify if:

• 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 any lumbar or lower thoracic fusion surgery or placement of other hardware.
• \> Grade 2 Spondylolisthesis at an affected or adjacent level.
• Cobb angle \>10 degrees.
• Sagittal vertical axis angle \>5 degrees
• BMI \>40.
• 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).

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• McCormick ZL, Conger A, Kendall R, Wagner G, Henrie AM, Littell M, Sperry BP, Petersen R, Cooper AN, Teramoto M, Burnham TR. A pragmatic randomized prospective trial of cooled radiofrequency ablation of the medial branch nerves versus facet joint injection of corticosteroid for the treatment of lumbar facet syndrome: 12 month outcomes. Pain Med. 2023 Dec 1;24(12):1318-1331. doi: 10.1093/pm/pnad107.

  PMID: 37578437 DERIVED

Results Point of Contact

• Title: Zachary McCormick, MD
• Organization: University of Utah Orthopaedic Center/ Physical Medicine & Rehabilitation

u6014808@umail.utah.edu

801-587-1493

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 3, 2018
• Study Start: October 1, 2018
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)