OBJECTIVE

To analyze the effectiveness and tolerability of various regimens for the use of tolperisone hydrochloride (TH) in the treatment of patients with acute nonspecific lower back pain (ALBP).

MATERIAL AND METHODS

90 patients with ALBP (54.3 [48.7; 61.3] years) were divided into 2 groups: group 1 (n=45) received basic therapy — NSAIDs, B vitamins and TH sustained release (450 mg/day per os), group 2 (n=45) used basic treatment and TH 2 ml intramuscularly 2 times a day for 5 days with a transition to a TH sustained release 450 mg/day per os. The total duration of the study was 30 days. We analyzed the visual analogue pain scale (VAS-B), the results of the modified modified Schober test (MMST), the medication adherence scale (Drug Attitude Inventory — DAI-10), the Epworth daytime sleepiness scale (ESS), functional activity associated with low back pain (Roland-Maurice questionnaire, RM), duration of TH intake (days), frequency and characteristics of adverse events (AE). At the screening visit, all patients were additionally divided depending on the intensity of pain according to VAS-B («mild», «moderate», «severe»).

RESULTS

There were no significant differences on the VAS-B scale between groups 1 and 2 in patients with mild pain; there was significantly more complete pain control in group 2 with moderate pain after 14 and 30 days, (p=0.0013, 14 days; p=0.0021, 30 days); among patients with severe pain, the best result after 30 days was observed in group 2 (p=0.0016). In all patients the range of motion in the lumbosacral spine (MSST) significantly increased and functional activity (RM) improved compared to the initial state: more significant in group 2 with moderate pain after 14 and 30 days and with severe pain after 30 days. There was a high adherence to therapy (DAI-10), more pronounced in the first 14 days in patients of group 1. Excessive daytime sleepiness (ESS) was not observed. For moderate pain, patients in group 2 used TH for a significantly shorter period of time (16.4±1.6 days) compared to patients in group 1 (19.6±2.2 days, p=0.0022). AE were mild and did not serve as a reason to refuse therapy.

CONCLUSION

A protocol for prescribing TH was proposed, based on stratification of patients according to VAS-B.The use of TH for ALBP is effective and safe. The proposed protocol for stratifying patients according to VAS-B level allows identifying the patients with step-by-step scheme of prescribing the drug for a period of 14 to 30 days.