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 2 Baseline patient characteristics per treatment group (ITT population)

Baseline characteristics	Test treatment (N = 62)	Reference treatment (N = 61)	p-value
Age, mean (± SD), years	51.54 (14.91)	51.21 (14.20)	0.895
Male, n%	34 (50%)	25 (37.9%)	0.160
Muscle spasm, n%	61 (89.7%)	61 (92.4%)	0.320
Finger-to-floor distance (± SD), cm	44.21 (16.74)	40.53 (15.73)	0.193
VAS score (± SD)	71.93 (11.31)	65.17 (12.14)	0.001^*

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: ITT intent-to-treat, SD standard deviation, VAS visual analogue score
^*indicates significance compared to reference treatment

ISSN: 1471-2474