Objective: to assess the impact of cyclobenzaprine therapy in real-world clinical practice on the severity of pain, functional capacity and the time taken to return to work in patients with non-specific back and neck pain, as well as to evaluate the drug's safety profile.

Material and methods. The multicentre study included 997 patients (full analysis set, FAS) aged 18 years or older, of whom 976 completed the study according to protocol – per-protocol (PP) population. Patients received Reloprim (cyclobenzaprine) at a dose of 5, 7.5 or 10 mg three times daily for up to 14 days. The primary endpoint was the change in functional limitations as assessed by the Roland–Morris Disability Questionnaire (RMDQ).

Results. The baseline RMDQ score was 12.52±5.57. By day 5, it had decreased significantly to 7.18±4.53, and by the end of the study to 1.89±2.42 (p<0.001). Pain intensity (baseline 6.79±1.46 points) decreased by 2.98±1.3 points by day 5 and by 5.85±1.72 points by the end of the observation period (p<0.001). The number of patients temporarily unable to work was reduced by almost half (from 10.75 to 5.94). The need for additional doses of non-steroidal anti-inflammatory drugs (NSAIDs) was reduced by more than half.

Conclusion. The use of cyclobenzaprine as part of a comprehensive treatment regimen for non-specific back and neck pain in real-world clinical practice is associated with a statistically significant reduction in the severity of pain and functional limitations as early as the first few days of treatment, with the effect continuing to improve by the end of the observation period.