ABSTRACT
Background Low back pain (LBP) costs the healthcare system billions of dollars each year. Intervertebral disc (IVD) degeneration is a significant cause of LBP, due to structural defects, biomechanical instability, and inflammation. First-line therapy for patients with LBP includes physical therapy, medication, and steroid injections. DiscSealTM was developed to provide patients who are refractory to first-line therapy with a minimally invasive treatment alternative to invasive surgical procedures. The product is a combination of poly-methyl methacrylate (PMMA) microspheres in hyaluronic acid (HA) that is injected under modified discography into the IVD. Methods Two pain specialist centers in Australia recruited eligible participants who were followed up for 180 days post-procedure. The procedure was conducted using a modified discography technique. Low back and leg pain was reported using the Visual Analogue Scale (VAS) while other endpoints included were Oswestry Disability Index (ODI), Clinician and Patient Global Impact of Change, and Patient Rating of Overall Health Status. The general analytical approach for all endpoints was descriptive in nature and 95% confidence intervals of means were estimated. Results The pilot study achieved its primary objective which was an absence of peri-treatment or post-treatment device-related Serious Adverse Events (SAE) during the first 90 days. There were no device-related serious adverse events recorded throughout the study. The mean LBP percentage change from baseline at 90 and 180 days was -27.0% and -42.3% respectively. The mean ODI percentage change from baseline at 90 and 180 days was -22.3 and -14.2% respectively. End of study improvements shows a 67.8% (20.83) increase in Overall Health Status, as well as positive results for Participant and Clinician Global Impact of Change. These results were achieved based on treating one diseased IVD, although 83.3% of patients were diagnosed with multiple diseased IVDs. Conclusions The results from this pilot study showed that DiscSealTM is safe and well-tolerated. Early efficacy shows that DiscSealTM may be a promising treatment option for people suffering from discogenic LBP that have not responded to first-line treatment options. A larger, statistically powered study where all diseased discs are treated should be completed to validate the promising results from this early feasibility study.
ABSTRACT
BACKGROUND: Magnetic resonance imaging (MRI), cerebrospinal fluid (CSF) analysis, and the McDonald's clinical criteria are currently utilized tools in diagnosing multiple sclerosis. However, a more conclusive, consistent, and efficient way of diagnosing multiple sclerosis (MS) is yet to be discovered. A potential biomarker, discovered using advances in high-throughput sequencing such as nuclear magnetic resonance (NMR) spectroscopy and other "Omics"-based techniques, may make diagnosis and prognosis more reliable resulting in a more personalized and targeted treatment regime and improved outcomes. The aim of this review was to systematically search the literature for potential biomarkers from any bodily fluid that could consistently and accurately diagnose MS and/or indicate disease progression. METHODS: A systematic literature review of EMBASE, PubMed (MEDLINE), The Cochrane Library, and CINAHL databases produced over a thousand potential studies. Inclusion criteria stated studies with potential biomarker outcomes for people with MS were to be included in the review. Studies were limited to those with human participants who had a clinically defined diagnosis of MS and published in English, with no limit placed on date of publication or the type of bodily fluid sampled. RESULTS: A total of 1,805 studies were recorded from the literature search. A total of 1,760 studies were removed based on their abstract, with a further 18 removed after considering the full text. A total of 30 studies were considered relevant and had their data retrieved and analyzed. Due to the heterogeneity of focus and results from the refined studies, a narrative synthesis was favored. CONCLUSION: Several promising candidate biomarkers suitable for clinical application in MS have been studied. It is recommended follow-up studies with larger sample sizes be completed on several potential biomarkers.
