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

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 bac...

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Published in:	JAMA : the journal of the American Medical Association 2017-07, Vol.318 (1), p.68-81
Main Authors:	Juch, Johan N. S, Maas, Esther T, Ostelo, Raymond W. J. G, Groeneweg, J. George, Kallewaard, Jan-Willem, Koes, Bart W, Verhagen, Arianne P, van Dongen, Johanna M, Huygen, Frank J. P. M, van Tulder, Maurits W
Format:	Article
Language:	eng
Subjects:	Adult Aged Back pain Care and treatment Chronic pain Chronic Pain - therapy Clinical trials Combined Modality Therapy Denervation Denervation - methods Design standards Diagnostic systems Exercise Therapy Female Humans Intervention Intervertebral discs Low back pain Low Back Pain - diagnosis Low Back Pain - therapy Lumbar Vertebrae Medical research Middle Aged Minimal Clinically Important Difference Nerve Block Original Investigation Pain Pain management Patient outcomes Patients Radio frequency Radiofrequency ablation Radiofrequency Therapy Randomization Sacroiliac Joint Treatment Failure Zygapophyseal Joint
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Summary:	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
ISSN:	0098-7484 1538-3598