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 1 Baseline patient characteristics per treatment group (per protocol population)

Baseline characteristics	Test treatment (N = 62)	Reference treatment (N = 61)	p-value
Age, mean (± SD), years	52.00 (± 14.88)	51.23 (± 14.51)	0.772
Male, n%	33 (53.2%)	23 (37.7%)	0.085
Muscle spasm, n%	55 (88.7%)	56 (91.8%)	0.567
Finger-to-floor distance (± SD), cm	44.52 (± 17.33)	41.02 (± 16.12)	0.249
VAS score (± SD)	72.03 (± 11.72)	65.20 (± 12.16)	0.002^*

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

ISSN: 1471-2474