Randomized controlled trials (RCTs) are considered the most rigorous way to conduct research for many reasons, including the inability for either the patient or researcher to know to which treatment arm they have been assigned. With many interventional pain treatments, however, RCTs are a challenge. For example, if studying a surgical treatment versus no treatment, it will not be possible to blind patients or researchers to which group is being studied. 

This is one reason that the Multisociety Pain Workgroup (MPW) recently presented comments to the Agency for Healthcare Research Quality regarding its draft systematic review Interventional Treatments for Acute and Chronic Pain: Systematic Review. Eleven pain societies representing the MPW signed on to the letter, which primarily addresses concerns regarding vertebral augmentation procedures for vertebral compression fractures.

By using only on RCTs in their systematic review, the authors of the review were not able to conclude that vertebroplasty was an effective tool for treating vertebral compression fractures. However, the studies looking at vertebroplasty used in the review skewed toward older individuals and, as the MPW noted, cannot be generalized to other vertebral augmentation procedures which have been found to have "statistically significant differences in morbidity and mortality, pain relief, restoration of vertebral anatomy, and quality of life." 

Several studies have determined that vertebral augmentation has morbidity and mortality benefits over non-surgical management, but conducting a trial that would provide the treatment to one group and not the other, the MPW argues, is a violation of the Declaration of Helsinki, which states that that "if a beneficial treatment for a condition has already been recognized, it is unethical to offer placebo in place of such treatment to anyone in a study of the same condition." In fact, the MPW cites evidence that "The mortality reduction for antiresorptive osteoporosis medications is 11% compared to 24% for vertebroplasty and 55% for kyphoplasty." They go on to cite a 2018 vertebral augmentation registry data set that found subjects' median pain scores decreased from 9 to 0 with the treatment.

The MPW is hopeful that this and other information provided in the letter will be considered for the final AHRQ report. You can read the full letter here.