Low back pain: results of an open clinical trial comparing the standard treatment alone to the combination of standard treatment and thiocolchicoside

Abstract

For symptomatic relief of low back pain, non-steroidal antiinflammatory drugs (NSAIDs) and analgesics are often in used in combination with muscle relaxants. However adverse effects, especially sedation, limit the use of some muscle relaxants. Thiocolchicoside (TCC) is a non-sedating muscle relaxant that has been shown to be safe and effective as monotherapy in the treatment of this problem. The present study was carried out to determine if the combination of thiocolchicoside and standard treatment is more effective than standard treatment alone. Ninety-three Turkish centers recruited adults presenting with acute and subacute low back pain. Each physician included four patients. Patients were randomized to receive either a NSAID or an analgesic for 5 to 7 days (referred to as “standard treatment”) or standard treatment plus 8 mg TCC (Muscoril) twice daily for 5 to 7 days. On inclusion and again on day 7, low back pain was evaluated with a visual analogue scale (VAS) and disability was evaluated with the Roland-Morris disability questionnaire. Pain and disability were evaluated again on day 31. A total of 155 patients were randomized to receive standard treatment alone and 174 received standardtreatment and TCC. The vast majority (98.2%) of the patients received a NSAID as standard treatment. The mean VAS and disability questionnaire scores of the two groups were equivalent at inclusion. At day 7, patients in both groups were improved but patients receiving TCC had significantly less pain (p<0.003) and disability (p=0.0005) than patients on standard treatment alone; this was also true at day 31. (p<0.005 and p=0.0005, respectively). The addition of TCC to NSAID standard treatment resulted more effective for the symptomatic treatment of low back pain than the NSAID alone. In addition, the combination was well tolerated and produced no more adverse effects than the NSAID alone.