Current Concepts | Literature Review Commentary
Lumbar and Sacral Radiofrequency
Neurotomy: Fatal Flaws of a Recent RCT
Juch JS, Maas ET, Ostelo RG, et al. Effect of radiofrequency denervation
PubMed ID: 28672319. Available at: https://www.ncbi.nlm.nih.gov/pubmed/28672319
on pain intensity among patients with chronic low back pain: The mint
randomized clinical trials. JAMA. 2017;318( 1):68-81.
Importance: Radiofrequency denervation is a commonly used treatment for chronic low
back pain, but high-quality evidence for its effectiveness is lacking.
Objective: To evaluate the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain.
Design, Setting, and Participants: Three pragmatic multicenter, nonblinded randomized
clinical trials on the effectiveness of minimal interventional treatments for participants
with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain
clinics in the Netherlands. Eligible participants were included between January 1, 2013,
and October 24, 2014, and had chronic low back pain, a positive diagnostic block at the
facet joints (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228
participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks
(combination trial, 202 participants) and were unresponsive to conservative care.
Interventions: All participants received a 3-month standardized exercise program and
psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number
of treatments in the trial was 3.
Main Outcomes and Measures: The primary outcome was pain intensity (numeric rating
scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured
3 months after the intervention. The prespecified minimal clinically important difference
was defined as 2 points or more. Final follow-up was at 12 months, ending October 2015.
Results: Among 681 participants who were randomized (mean age, 52. 2 years; 421 women
[ 61.8%], mean baseline pain intensity, 7. 1), 599 (88%) completed the 3-month follow-up,
and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity
between the radiofrequency denervation and control groups at 3 months was -0.18 (95%
CI, -0.76 to 0.40) in the facet joint trial; -0.71 (95% CI, - 1. 35 to -0.06) in the sacroiliac joint
trial; and -0.99 (95% CI, - 1.73 to -0.25) in the combination trial.
Conclusions and Relevance: In 3 randomized clinical trials of participants with chronic
low back pain originating in the facet joints, sacroiliac joints, or a combination of facet
joints, sacroiliac joints, or intervertebral disks, radiofrequency denervation combined
with a standardized exercise program resulted in either no improvement or no clinically
important improvement in chronic low back pain compared with a standardized exercise
program alone. The findings do not support the use of radiofrequency denervation to treat
chronic low back pain from these sources.
Trial Registration: trialregister.nl Identifier: NTR3531.
Reprinted with permission.
Alison Stout, DO
Evergreen Sport and Spine Center
Kirkland, WA, USA
H. Michael Guo, MD, PhD
Department of Orthopedic Surgery
Spine Division, Duke University
Durham, NC, USA
Jerome Schofferman, MD
Sausalito, CA, USA