[Efficiency evaluation of the Neuromidin in the treatment of pain of the patients with discogenic lumbosacral radiculopathy: results of a multicenter post-registration prospective open comparative trial].

OBJECTIVE: Evaluation of the effect of Neuromidine on the dynamics of pain syndrome in the treatment of patients with discogenic lumbosacral radiculopathy.

MATERIAL AND METHODS: Patients with a confirmed diagnosis of discogenic lumbosacral radiculopathy no more than one year old and moderate intensity of pain syndrome on a visual analog scale were included in the main group (OH, n =62, age - 53.1±15.6 yrs) and the comparison group (HS, n =40, age - 53.7±12.9 yrs). OG patients received Neuromidine (15 mg/1 mL 1 once a day IM for 10 days, then 20 mg 3 times a day for 8 weeks) in addition to the standard drug therapy, HS patients received only standard drug therapy. The duration of the study was 8 weeks. The degree of decrease in the intensity and dynamics of pain syndrome, activity and frequency of pain in the lumbar spine, changes in the level of physical activity, and the severity of emotional disorders were evaluated. The level of inflammatory markers in the blood and the dynamics of monosynaptic spinal H-reflex parameters were evaluated.

RESULTS: Before the study, there were no statistically significant differences there were no results of clinical and laboratory-instrumental examination between groups. After 8 weeks, the reduction of pain by VAS in the main group was statistically significant in contrast to the comparison group ( p =0.0001). In the main group there was a statistically significant increase in the mean cognitive impairment score ( p =0.0029), as well as an improvement in psycho-emotional state with a significant decrease in GAD-7 ( p =0.0002) and PHQ-9 ( p =0.0096). After 8 weeks of therapy, IL-6 level in the main group was statistically significantly lower ( p =0.0027) than in the comparison group. The results of H-reflex study revealed an increase in its amplitude and some shortening of latency at the end of Neuromidine therapy. The drug had no undesirable side effects and was well tolerated.

CONCLUSION: Administration of Neuromidine 15 mg/1 ml once a day intramuscularly for 10 days followed by 20 mg 3 times a day for 8 weeks has an effective analgesic effect as adjuvant therapy in patients with discogenic lumbosacral radiculopathy. The inclusion of Neuromidine in the complex treatment of patients with pain syndrome in discogenic radiculopathy is superior in efficacy to standard drug therapy.