A randomized controlled trial evaluating the short-term efficacy of a single-administration intramuscular injection with the fixed combination of thiocolchicoside-diclofenac versus diclofenac monotherapy in patients with acute moderate-to-severe low back pain

Table 4 Percentage of patients attaining > 30% reduction in pain intensity

Efficacy outcome	Timepoint	Test treatment (Ν = 62)	Reference treatment (Ν = 61)	p-value	Unadjusted OR (95% CI)	Adjusted OR (95% CI)^†
> 30% reduction in pain intensity, (n%)	1 h	35 (56.5%)	23 (37.7%)	0.037^*	1.949 (0.980 to 3.876)	1.914 (0.937 to 3.910)
> 30% reduction in pain intensity, (n%)	3 h	57 (91.9%)	35 (57.4%)	< 0.01^*	8.469 (2.977 to 24.093)	8.100 (2.803 to 23.403)

Definitions: Test treatment: Fixed dose combination of diclofenac 75 mg (as diclofenac sodium)- thiocolchicoside 4 mg/4 ml intramuscular injection; Test treatment: Diclofenac 75 mg/3 ml (as diclofenac sodium) intramuscular injection
Abbreviation: CI confidence interval, OR odds ratio
^*indicates significance compared to reference treatment
^†adjusted for age and sex

ISSN: 1471-2474