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 3 Efficacy assessments

Efficacy outcome	Timepoint	Test treatment (N = 62)	Reference treatment (N = 61)	Treatment Difference (95% CI)^*	p-value
VAS score, mean (± SD)	Baseline	72.03 (± 11.72)	65.20 (± 12.16)	-
	1 h	45.37 (± 16.28)	48.98 (± 18.76)	-10.032 (-15.073 to -4.990)	< 0.01^†
	3 h	31.56 (± 15.08)	44.52 (± 17.33)	-14.654 (-20.450 to -8.857)	< 0.01^†
Finger-to-floor-distance, mean (± SD)	Baseline	44.52 (± 17.33)	41.02 (± 16.12)
	1 h	32.21 (± 16.64)	33.13 (± 16.26)	-3.794 (-7.055 to -0.534)	0.023^†
	3 h	25.55 (± 13.85)	30.10 (± 14.76)	-6.907 (-10.081 to -3.733)	< 0.01^†

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
Abbreviations: CI confidence interval, SD standard deviation, VAS visual analogue scale
^*indicates significance compared to reference treatment
^†treatment difference scores were estimated from the difference in the mean changes compared to baseline, as estimated by covariance model analysis, between the test and the reference group. The difference was considered significant if p < 0.05

ISSN: 1471-2474