Conclusion
LBP, pain
The findings of this trial have demonstrated that the single IM injection of FDC diclofenac -thiocolchicoside is superior compared to monotherapy with IM diclofenac in the symptomatic treatment of patients with acute non-specific moderate-to-severe LBP, using both patient- and investigator-based assessments The fixed combination resulted rapidly within 3 h post-administration in statistically significantly greater and sustained improvement in pain intensity and mobility and was well-tolerated. Following the promising preliminary short-term beneficial effects, further double-blinded, double-dummy randomized trials that will investigate both the short- and long-term administration effects of the reference versus the test treatment on a larger cohort of patients will be conducted to verify the current results.