[Optimizing the diagnosis and treatment of dorsalgia in real-world clinical practice: the secondary endpoint of the DORISS multicenter observational study].

Abstract

Objective: To evaluate the efficacy of Ipigrix in the complex treatment of patients with dorsalgia (DA) of the lumbosacral spine based on the results of the DORISS observational non-interventional multicenter study.

Material and methods: Overall 3563 patients with verified diagnoses of DA at 200 clinical centers within the Russian Federation who received comparable baseline therapy according to nosological standards were examined, some of them additionally received oral or staggered treatment with Ipigrix. Baseline therapy for DA was given to 376 patients (treatment group 1), combination of baseline with oral Ipigrix was given to 1026 patients (group 2), and combination with staggered prescription of ipidacrine - to 2161 (group 3). Secondary endpoint of the study included analysis of the improvement of clinical symptoms, values of pain NRS and DN4 scales together with Roland-Morris questionnaire during the period of observation depending on the therapy with an assessment of its safety.

Results: The results of the analysis of covariance allowed to exclude the influence of confounders (age and initial indicators of the utilized scales) on DA outcomes and demonstrated the greatest pain reduction in patients who additionally received Ipigrix via the staggered scheme. The inter-group comparison aligned by pseudorandomization showed statistically significant benefits of combined therapy regardless of the type of Ipigrix administration concerning main vertebral syndrome manifestations, sensory and motor disturbances, relief of pain, as well as neuropathic symptoms, improvement of neurophysiological parameters and restoration of life functioning without serious drug related adverse events.

Conclusion: Ipigrix (ipidacrine) can be considered an effective and safe adjuvant analgesic in the treatment of DA.