Étude multicentrique, randomisée, en double aveugle, contrôlée versus placebo évaluant l’efficacité de la thiocolchicoside au cours de la lombalgie aiguë

Abstract

Objective. – To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg–2 ml) compared to placebo administered twice daily for five 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 assessed by visual analogue 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 forty nine (149) 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 < 0.001). Hand- to floor distance and muscle spasm determined by palpation decreased significantly on day 5 in thiocolchicoside group ( p < 0.0005 for both). According to the patients’ global evaluation, 76.8% of patients in thiocolchicoside group evaluated the treatment as very good/good ( p < 0.0005). Also a significant difference was observed in favor of thiocolchicoside group in the total paracetamol consumption ( p < 0.001). Treatment was well tolerated in both groups and none of the patients was withdrawn from the study due to an adverse effect. Conclusion. – Twice daily administration of 4 mg thiocolchicoside for five days provides an efficient and safe treatment for patients with acute low back pain accompanied by muscle spasm.