title: To compare the efficacy and safety of fixed dose combination of thiocolchicoside and aceclofenac versus chlorzoxazone, aceclofenac and paracetamol in patients with acute lower backache associated with muscle spasm.
abstract: BACKGROUND
  The fixed dose combinations (FDCs) of muscle relaxants, non-steroidal anti-inflammatory drugs and paracetamol are commonly prescribed in the treatment of acute lower backache.
  
  
  OBJECTIVE
  The present study was undertaken with the aim of comparing the efficacy and safety of FDCs of thiocolchicoside and aceclofenac versus chlorzoxazone, aceclofenac and paracetamol in patients with acute lower backache associated with muscle spasm.
  
  
  METHODS
  A total of 100 patients between ages range from 18 and 55 years having low back pain of ≤7 days duration were randomly divided into two groups. Group A was prescribed thiocolchicoside (4 mg) + aceclofenac (100 mg) while Group B was prescribed chlorzoxazone (500 mg) + aceclofenac (100 mg) + paracetamol (325 mg) orally twice daily for 7 days. Severity of pain at rest and on movement was recorded using visual analogue scale. Muscle spasm was evaluated by hand-to-floor distance and Lasegue's maneuver. Readings were noted on day 1 (baseline), day 3 and day 7.
  
  
  RESULTS
  There was statistically significant reduction in severity of pain and muscle spasm on day 3 and day 7 in both groups. There was no statistically significant difference in pain relief and muscle spasm among the treatment groups but clinically showed better improvement in the Group A. The adverse drug reactions occurring during study showed a statistically significant better safety profile in the Group A than Group B.
  
  
  CONCLUSIONS
  These findings confirm that FDC of thiocolchicoside and aceclofenac is a preferred option for patients with lower backache pain associated with muscle spasm.
authors.affiliation: Department of Orthopedics, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana, India.
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Kumar
authors.affiliation: Department of Pharmacology, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana, India.
authors.forename: Seema
authors.initials: S
authors.lastname: Rani
authors.affiliation: Department of Orthopedics, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana, India.
authors.forename: Ramchander
authors.initials: R
authors.lastname: Siwach
authors.affiliation: Department of Pharmacology, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana, India.
authors.forename: Prem
authors.initials: P
authors.lastname: Verma
keywords: Fixed dose combinations; low backache; muscle relaxants; non-steroidal inflammatory drugs; visual analog scale