Radiofrequency ablation (RFA) has emerged as a popular intervention for chronic pain management, including pain originating in the sacroiliac joint. It offers a less invasive option than surgery but with better results than the previous standard treatment with steroid and anesthetic injections. Procedure volumes have enjoyed significant growth in the market in recent years. The evidence supporting this intervention, in the form of randomized controlled trials, however, is both thin and mixed. The purpose of this systematic review is to evaluate the body of randomized controlled trials (RCTs) to determine the quality of support for and against the use of radiofrequency ablation to treat sacroiliac joint (SIJ) pain. Several important new papers have emerged since previous systematic reviews with similar objectives were published. The review was conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, and three databases were used: PubMed, Google Scholar, and Scopus. Only RCTs were sought, and no other filters, such as a historical timeline cut-off, were used. Among 95 publications that returned in response to the query, 16 were ultimately accepted as meeting the inclusion/exclusion criteria. The Cochrane risk-of-bias tool was utilized as a quality assessment measure, and the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) framework was used to assess the certainty of the evidence. Among the included publications, 15 out of 16 publications featured positive results and conclusions that supported the use of RFA in treating chronic sacroiliac joint pain. The single negative study was also the largest trial (n=681), but it was identified as "High Risk" using the Cochrane risk-of-bias tool. It included several design flaws including neither operator nor patient blinding, missing information, use of inconsistent treatment modalities across groups, and disproportionate drop-out rates. Despite its flaws, we have included this study in the present review because of its sheer size. Taken in aggregate, the total body of research included in this review supports this intervention. Questions continue to exist around whether there are clinically significant benefits associated with different RFA modalities (for example, unipolar vs. bipolar), with convincing evidence supporting each of them. Finally, it can be concluded that while the benefits are reasonably and justifiably supported in this patient population for up to one year, there is a dearth of evidence beyond a 12-month post-intervention follow-up.
Sickle cell disease (SCD) is an inherited disorder that impairs red blood cells (RBCs) and disrupts the delivery of oxygen to tissues. There is currently no cure. Symptoms can appear as early as six months of age and include anemia, acute episodes of pain, swelling, infections, delayed growth, and vision problems. A growing number of therapies are being investigated for reducing these episodes of pain, also known as vaso-occlusive crises (VOCs). The research literature evidence, however, currently includes far more approaches that have not shown superiority versus placebo than ones that have been proven effective. The purpose of this systematic review is to evaluate the body of randomized controlled trials (RCTs) to determine the quality of support for and against the use of a variety of current and emerging therapies for treading SCD VOCs. Several important new papers have emerged since previous systematic reviews with similar objectives were published. This review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and focused on PubMed exclusively. Only RCTs were sought, and no other filters, except for a five-year historical timeline cut-off, were used. Of the 46 publications that were returned in response to the query, 18 were ultimately accepted as meeting the pre-established inclusion criteria. The Cochrane risk-of-bias tool was utilized as a quality assessment measure, and the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) framework was used to assess the certainty of the evidence. Among the included publications, five out of 18 featured positive results with superiority and statistical significance versus placebo for either reduction in pain score or number/duration of VOCs. The approaches featured therapies ranging from de novo molecules to currently available drugs approved for other indications to naturally occurring metabolites such as amino acids and vitamins. A single therapy, arginine, was supported for both clinical endpoints: pain score reduction and shortened VOC duration. Currently, two therapies are approved by the United States Food and Drug Administration (FDA) and are commercially available (crizanlizumab, ADAKVEO and L-glutamine, Endari). All other therapies are investigational only in nature. Several studies included measurement of biomarker endpoints as well as clinical outcomes. Generally, beneficial outcomes related to improving biomarker levels did not also translate into statistically significant reduction of pain scores or number/duration of VOCs. While measuring biomarkers may contribute to the understanding of pathophysiology, it does not appear to directly offer predictive value toward treatment success clinically. It can be concluded that there exists a specific opportunity to design, fund, and execute investigations that both compare emerging and existing therapies versus one another and compare combinational therapies versus placebo.
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