NCT03614793

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

Completed NA Results posted Last updated 16 July 2024

What this trial tests

NA trial testing Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome in Lumbar Facet Syndrome in 39 participants. Completed in 18 September 2023.

Timeline

1 October 2018

Primary endpoint
18 September 2023

18 September 2023

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	1 October 2018
Primary completion	18 September 2023
Estimated completion	18 September 2023
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Lumbar Facet Syndrome — all drugs for Lumbar Facet Syndrome →

Sponsor

University of Utah

Who can join

21 and older, any sex, with Lumbar Facet Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numeric Pain Rating Scale (NPRS) Primary · 3 Months

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.

Group	Value	95% CI
Cooled Radiofrequency Ablation Procedure	14
Facet Joint Inject Procedure	3

Decrease in Oswestry Disability Index (ODI) Score Secondary · 6 Months

ODI Percentage 0% to 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 has 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 livi

Group	Value	95% CI
Cooled Radiofrequency Ablation Procedure	3
Facet Joint Inject Procedure	8

Patient Global Impression of Change (PGIC) Secondary · 6 Months

The PGIC questionnaire allows participants to give their opinion on how well the treatment worked for them. Participants are asked to rate the status of their lower back pain after treatment: Very much worse, Much worse, Minimally worse, No change, Minimally improved, Much improved and Very much improved. The variable for this outcome was how many participants reported equal to or greater than a 6, which would be "Much improved" or "Very much improved."

Group	Value	95% CI
Cooled Radiofrequency Ablation Procedure	11
Facet Joint Inject Procedure	4

Numeric Pain Rating Scale (NPRS) Point Change Secondary · 6 Months

This outcome was measured at 6 months from the NPRS scale, 0 being no pain to 10 being the worst pain imaginable, to see how many participants had an equal to or greater than a 2-point reduction in their pain compared to baseline.

Group	Value	95% CI
Cooled Radiofrequency Ablation Procedure	13
Facet Joint Inject Procedure	3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   McCormick ZL, Conger A, Kendall R, Wagner G, et al · · 2023 · cited 12× · PMID 37578437 · DOI 10.1093/pm/pnad107