In three randomised trials, treatment of chronic low back pain with radiofrequency denervation, resulted in either no improvement or no clinically important improvement, according to a Dutch study.
Low back pain causes more disability than any other condition and has major social and economic consequences. Even though radiofrequency denervation is a commonly used treatment, high-quality evidence for its effectiveness is lacking. Dr Esther T Maas, of Vrije Universiteit Amsterdam, the Netherlands, and colleagues report the results of three randomised clinical trials that were conducted in 16 pain clinics in the Netherlands. Trial participants, who were unresponsive to conservative care, had chronic low back pain originating in potential sources of the spinal column: the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks.
All participants received a 3-month standardised exercise programme and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well, which is usually a 1-time procedure, but the maximum number of treatments in the trial was three.
Among 681 participants who were randomised, 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The researchers found that two trials assessing radiofrequency denervation for the sacroiliac joints and a combination of the facet joints, sacroiliac joints, or intervertebral disks showed a statistically significant but not clinically important improvement in pain intensity three months after the intervention. No clinically important or statistically significant differences between the groups were shown in the trial assessing radiofrequency denervation for facet joint pain.
"The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources," the authors write.
A limitation of the study was that because the aim was to provide evidence of the added value of radiofrequency denervation in a multidisciplinary setting, as done in daily practice, participants and clinicians were not blinded.
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.
Authors
Johan NSS Juch, Esther T Maas, Raymond WJG Ostelo, J George Groeneweg, Jan-Willem Kallewaard, Bart W Koes, Arianne P Verhagen, Johanna M van Dongen, Frank JPM Huygen, Maurits W van Tulder
[link url="https://www.sciencedaily.com/releases/2017/07/170703121043.htm"]JAMA material[/link]
[link url="http://jamanetwork.com/journals/jama/article-abstract/2635632"]JAMA abstract[/link]