INTERPRETING THE MINT RANDOMIZED TRIALS EVALUATING RADIOFREQUENCY ABLATION FOR LUMBAR FACET AND SACROILIAC JOINT PAIN
Study type: Critical opinion – response to a publication
Publication: Reg. Anesth. Pain Med 2018; 43(1) (Link to PubMed)
Key Words: Chronic low back pain - Thermal RF - Procedure validation
In July 2017, Juch* and collaborators published the results of three randomized clinical trials (RCTs) evaluating the effect of radiofrequency denervation on pain intensity among patients with chronic low back pain.
These RCTs were the base of the MINT study (Minimal Interventional Treatment), published in the Journal of the American Medical Association (*Juch, JNS, et al. JAMA. 2017;318:68–81).
The study was funded by the Netherlands Organization for Health Research and Development, the Dutch Society of Anesthesiology, and the Dutch Health Insurance Companies.
MINT STUDY CLAIMS
The MINT study raised important questions regarding the efficacy of RFA, as it concluded the following:
- RFA combined with a standardized exercise program results in no clinically meaningful improvement in chronic low-back pain; compared with the standardized exercise program alone.
- The use of RFA in the treatment of low back pain cannot be supported and should be reserved for research purposes.
- Radiofrequency denervation is no longer being reimbursed in the Netherlands. Exercise and physiotherapy are reimbursed only for a limited number of sessions; for those who can afford private health insurance.
RESPONSE TO THE MINT STUDY – PROVENZANO ET AT
Six months after the publication of the MINT study, a response to the claims thereof came from Provenzano and collaborators. The authors conclude that the MINT RCT was significantly flawed in three major areas:
- Study design and data interpretation: The MINT analyses were not blinded. Moreover, statistical analyses applied were not valid, as they failed to adjust to multiple group averages.
- Patient selection: The authors of the MINT study did not use controlled diagnostic facet blocks, which is a critical step in selecting patients that could benefit from RFA.
- RFA procedure technical aspect: the anatomical approach for cannula insertion as well as the lesion time were not appropriate and might have influenced the outcomes of the study.
Provenzano and collaborators. conclude that the MINT study is flawed and inconclusive. Moreover, it obstructs the management of patients with chronic low back pain, originating from the facet and sacroiliac joints, from receiving properly performed RFA.