Evaluation of the effect of Hyalase injection into Hypertrophic Ligamentum Flovum on clinical symptoms and MRI findings in lumbar spinal canal stenosis

Abstract

Hyaluronic acid is one of the necessary materials for the formation of connective tissue, so it is thought that by injecting hyalase (hyaluronic acid separating enzyme hyaluronidase) into the flavonoid ligament, we can reduce the thickness before it calcifies. The aim of this study was to answer the question of whether injection of hyaluronidase into the flavum ligament with increased fibrinolysis leads to a decrease in ligament size and reduction or elimination of symptoms of canal stenosis caused by hypertrophy.

Methods: In this trial, block randomization was used to achieve two groups with equal sample size. Forty codes were generated in two intervention groups with a sample size equal to the sequence of random blocks. Then, at the time of admission, one envelope was randomly assigned to each patient. After obtaining written consent, they are randomly selected and placed in the yellow ligament under the block of injection of hyalase injection of 1500 units mixed with 40 mg of methylprednisolone with a volume of 1 ml. In the second group, 1500 units of hyalase are mixed with 40 mg of methylprednisolone with a volume of 1 ml by injection of transformin at the narrow surface. MRI is obtained again and MRI findings are statistically analyzed before and after injection after data collection.

Results: The mean age of patients (CI 95%; 56.74-65.11) was 60.93 ± 13.10 years. In the first group, 50% of patients are male and 50% female, and in the second group, 40% are male and 60% are female. The study of patients' age shows that the mean age in the first group with 60.35 ± 11.71 years is not significantly different from the second group with 61.50 ± 14.63 years. Studies on the remission of clinical symptoms after treatment indicate that group one with an average of 82.00 ± 24.41% significantly improved than group two with an average of 51.50 ± 24.34% . Studies of the percentage of improvement of CSF flow cut after treatment indicate that group one with an average of 53.75 38 38.28% significantly improved than group two with an average of 5.00 15 15.39%. There is a significant relationship between age and the rate of reduction of patients' symptoms and this relationship is moderate. (PV <0.001; Corelation Coefficient = 0.666)