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Original Investigation
July 4, 2017

Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back PainThe Mint Randomized Clinical Trials

Author Affiliations
  • 1Department of Anesthesiology, Erasmus University Medical Centre, Rotterdam, the Netherlands
  • 2Department of Health Sciences, Faculty of Earth and Life Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
  • 3The EMGO+ Institute for Health and Care Research, Amsterdam, the Netherlands
  • 4Department of Epidemiology and Biostatistics, Vrije Universiteit Medical Centre Amsterdam, Amsterdam, the Netherlands
  • 5Department of Anesthesiology, Rijnstate hospital, Velp, the Netherlands
  • 6Department of General Practice, Erasmus University Medical Centre, Rotterdam, the Netherlands
JAMA. 2017;318(1):68-81. doi:10.1001/jama.2017.7918
Key Points

Question  What is the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain?

Findings  In 3 randomized clinical trials including 681 participants with chronic low back pain originating from the facet joints, sacroiliac joints, or a combination of these or the intervertebral disks, radiofrequency denervation combined with exercise compared with exercise alone resulted in either no significant difference in pain intensity, or a difference smaller than the prespecified minimal clinically important difference after 3 months.

Meaning  The study findings do not support the use of radiofrequency denervation for chronic low back pain originating from these sources.

Abstract

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

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