Clinical comparative study: efficacy and tolerability of tolperisone and thiocolchicoside in acute low back pain and spinal muscle spasticity.
METHODS
We performed a multicentric, randomized, comparative clinical trial. Eligible patients were randomly assigned to receive 150 mg of Tolperisone thrice daily or 8 mg of Thiocolchicoside twice daily for 7 days.


OBJECTIVE
To assess the efficacy and tolerability of Tolperisone in comparison with Thiocolchicoside in the treatment of acute low back pain with spasm of spinal muscles.


BACKGROUND
No head on clinical trial of Tolperisone with Thiocolchicoside is available and so this study is done.


METHODS
The assessment of muscle spasm was made by measuring the finger-to-floor distance (FFD), articular excursion in degrees on performing Lasegue's maneuver and modified Schober's test. Assessment of pain on movement and spontaneous pain (pain at rest) of the lumbar spine was made with the help of visual analogue scale score.


RESULTS
The improvement in articular excursion on Lasegue's maneuver was significantly greater on day 3 (p = 0.017) and day 7 (p = 0.0001) with Tolperisone as compared to Thiocolchicoside. The reduction in FFD score was greater on day 7 (p = 0.0001) with Tolperisone. However there was no significant difference in improvement in Schober's test score on day 3 (p = 0.664) and day 7 (p = 0.192). The improvement in pain score at rest and on movement was significantly greater with Tolperisone ((p) = 0.0001).


CONCLUSIONS
Tolperisone is an effective and well tolerated option for treatment of patients with skeletal muscle spasm associated with pain.
Department of Orthopedics, Jubilee Missions Medical College, Thrissur, India.
Rajeev
R
Rao
Atul
A
Panghate
Ajay
A
Chandanwale
Indrajeet
I
Sardar
Mriganka
M
Ghosh
Modan
M
Roy
Bireswar
B
Banerjee
Ankur
A
Goswami
Prakash P
PP
Kotwal