Nov 22, 2017
Newswise — The MINT Trials are irredeemably flawed by study design, patient selection, procedural technique, and data analysis. That's the conclusion of a statement signed November 21st by the Multisociety Pain Workgroup (MPW), a collection of pain societies comprised of physicians who prescribe and/or perform interventional spine procedures to accurately diagnose and treat patients suffering from spine pathologies.
The MINT randomized clinical trials[1] compared a stand-alone 3-month standardized exercise program coupled with psychological support to the same program with the addition of radiofrequency abalation (RFA) for treatment of chronic low-back pain. The investigators reported that the RFA arm resulted in no clinically meaningful improvement in chronic low-back pain compared with the standardized exercise program alone, and they concluded that RFA should be reserved for research purposes only. The study was funded by the Netherlands Organization for Health Research and Development, the Dutch Society of Anesthesiology, and the Dutch Health Insurance Companies.
ASRA, along with 11 other pain societies that signed on to the MPW statement, has identified numerous flaws with the study and its findings that negate the otherwise successful results found with the use of RFA in some patients.
Several studies have been published that establish the effectiveness of RF neurotomy when performed according to standard practice, using large-gauge electrodes with anatomically correct needle placement in patients with confirmed facetogenic pain. Two such studies have demonstrated successful use of RFA using appropriate patient selection and technique. Collectively, these studies reported 55-60% of patients experiencing at least 80% pain relief using the treatment.[2-3]
Writing in Regional Anesthesia and Pain Medicine,[4] ASRA Board members David Provenzano, MD, Asokumar Buvanendran, MD, Oscar A. de León-Casasola, MD, Samer Narouze, MD, PhD, and Steven P. Cohen, MD, noted the importance of international educational efforts to ensure physicians are treating the right patients with appropriate techniques.
"The results of the MINT trial are inconclusive and may prevent patients with chronic low back pain originating from the facet and sacroiliac joints from receiving properly performed RFA," they concluded.
The authors have also developed Key Points in Advocating for RF Neurotomy Coverage to assist physicians in their practice.
References
- ^ Juch JS, Maas ET, Ostelo RG, et al. Effect of radiofrequency denervation on pain intensity among patients with chronic low back pain: The mint randomized clinical trials. JAMA. 2017;318(1):68- 81.
- ^ Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine 2000; 25:1270- 1277.
- ^ MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Lumbar medial branch radiofrequency neurotomy in New Zealand. Pain Med 2013; 14:639-645.
- ^ Provenzano DA, Buvanendran A, de Leon-Casasola O, Narouze S, Cohen SP. Interpreting the MINT randomize trials evaluating radiofrequency ablation for lumbar facet and sacroiliac joint pain. Reg Anesth Pain Med 2018;43: In press.
Read the Multisociety Workgroup Statement
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