Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain.
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.


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 < 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 the 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 Treatment was well tolerated in both groups and none of the patients was withdrawn from the study due to an adverse effect.


CONCLUSIONS
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.
Tüzün
Fikret
F
Department of Physical Medicine and Rehabilitation, Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey.
Unalan
Halil
H
Oner
Nazan
N
Ozgüzel
Hayri
H
Kirazli
Yeşim
Y
Içağasioğlu
Afitap
A
Kuran
Banu
B
Tüzün
Sansin
S
Başar
Günnur
G
D000208:Acute Disease; D000328:Adult; D003078:Colchicine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D010147:Pain Measurement; D011446:Prospective Studies; D013035:Spasm / Q000188:drug therapy*; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D003078:Colchicine; C004280:thiocolchicoside