Efficacy of thiocolchicoside in Indian patients suffering from low back pain associated with muscle spasm.

Low back pain (LBP), a high prevalent condition among middle aged population, is usually associated with 'muscle spasm' that is responsible for giving rise to pain as well as its persistence. Muscle spasm is an involuntary, painful contraction of muscles that interferes with the function and cause of muscular disorder. Therefore centrally acting skeletal muscle relaxants, also called lissive drugs, are commonly used for its treatment. Sometimes these are combined with NSAIDs. The use of centrally acting skeletal muscle relaxants, though efficacious, is associated with frequent development of dose-related adverse drug reactions like sedation, impairment of voluntary motor functions and ataxia. So there is an urgent need for newer better drugs for treatment of conditions associated with muscle spasm. The objective of this study was to assess the efficacy and safety of oral thiocolchicoside (TC), a natural glycoside as compared to an adrenergic alpha 2 agonist tizanidine (TZ) in the Indian patients with LBP accompanied by muscle spasm. In this randomised, non-cross over clinical study, 60 adult Indians aged between 18 and 65 years with clinical diagnosis of muscle spasm associated with low back pain were enrolled. Patients satisfying the inclusion and exclusion criteria were either treated with TC and TZ for one week duration. Visual analogue scale (VAS) for pain at rest and VAS for tiredness, drowsiness, dizziness and alertness was used as the self-rated primary efficacy and safety variable. Pain was also assessed by mobility assessment; muscle spasm assessment and analgesic consumption. Data obtained from 58 patients (those who completed the study) indicated that in this one week study both TC and TZ provided sustained symptoms relief compared with the baseline. There was statistically significant reduction in severity of symptoms from day 0 to day 7 in both the groups. Patients were followed up on 3rd and 7th day and severity score of various parameters was recorded. There was significant difference among the treatment groups in favour of TC than TZ in efficacy parameters thus showing TC is at slightly better effective than TZ and in case of safety, TC scores significantly better over TZ in the patients with accompanying muscle spasm. These findings confirm that TC is a preferred option for the LBP with muscle spasms.

RCT Entities:   Population Interventions Outcomes