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Multicenter, randomized, double-blinded, placebo-controlled trial
OBJECTIVE
To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg-2 ml) compared to placebo administered twice daily for 5 days in patients suffering from acute low back pain.
PATIENTS AND METHODS
Multicenter, randomized, double-blinded, placebo-controlled trial. The study was conducted between July 1998 and March 2000 in five centers. Hospitalized patients with acute low back pain were included. The primary evaluation criterion was spontaneous pain at rest assessed by visual analog scale (VAS). Hand-to-floor distance, muscle spasm intensity, patients' global evaluation and analgesic tablet (paracetamol) consumption were used as secondary evaluation criteria.
RESULTS
One hundred and forty nine patients were included. Both groups showed improvement on spontaneous pain assessed by VAS at the end of day 1; however, improvement was statistically significant in thiocolchicoside group on day 3 (P
CONCLUSION
Twice daily administration of 4 mg thiocolchicoside for 5 days provides an efficient and safe treatment for patients with acute low back pain accompanied by muscle spasm.
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