Dataset Information

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

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.

SUBMITTER: Juch JNS

PROVIDER: S-EPMC5541325 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundFacet joint pain is a common cause of chronic low back pain (CLBP). Radiofrequency (RF) denervation is an effective treatment option.PurposeA systematic review and network meta-analysis (NMA) was performed to evaluate and compare the efficacy and effectiveness of different RF denervation treatments in managing facet joint-derived CLBP.MethodsThe Cochrane Library, Embase, PubMed, and China Biology Medicine were searched to identify eligible randomized controlled trials (RCTs) from January 1966 through December 2021. Interventions included conventional radiofrequency denervation (CRF), pulsed radiofrequency denervation (PRF), pulsed radiofrequency treatment of the dorsal root ganglia (PRF-DRG), radiofrequency facet capsule denervation (RF-FC), and radiofrequency ablation under endoscopic guidance (ERFA). The outcome was the mean change in visual analog scale (VAS) score from baseline. A random-effects NMA was used to compare the pain relief effects of the interventions over the short term (≤6 months) and long term (12 months). The rank of effect estimation for each intervention was computed using the surface under the cumulative ranking curve.ResultsA total of 10 RCTs with 715 patients met the inclusion criteria. Moderate evidence indicated that CRF denervation had a greater effect on pain relief than sham control in the short term (standardized mean difference (SMD) -1.58, 95% confidence intervals (CI) -2.98 to -0.18) and the long term (SMD -4.90, 95% CI, -5.86 to -3.94). Fair evidence indicated that PRF denervation was more effective than sham control for pain over the long term (SMD -1.30, 95% CI, -2.17 to -0.43). Fair evidence showed that ERFA denervation was more effective for pain relief than sham control in the short term (SMD -3.07, 95% CI, -5.81 to -0.32) and the long term (SMD -4.00, 95% CI, -4.95 to -3.05). Fair evidence showed that RF-FC denervation was more effective for pain relief than sham control in the long term (SMD -1.11, 95% CI, -2.07 to -0.15). A fair level of evidence indicated that PRF-DRG denervation was more effective for pain relief than sham control in the short term (SMD -5.34, 95% CI, -8.30 to -2.39).ConclusionRF is an effective option for patients diagnosed with facet joint-derived CLBP.Systematic Review Registration: Identifier: CRD42022298238.

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