STUDY DESIGN: 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. PURPOSE: 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. OVERVIEW OF LITERATURE: 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.
Colchicine ; Head ; Humans ; Low Back Pain ; Muscle Spasticity ; Muscle, Skeletal ; Muscles ; Spasm ; Spine ; Tolperisone

Conservative treatment is the main therapy for cervicobrachial syndrome, scapulohumeral periarthritis, and lumbago as diseases with both pain and myotonia. The-conservative treatment mainly consists of medication, physiotherapy, and kinesiotherapy. In the recent years, attempts have been made to give relief to myotonia through combination therapy with antiinflammatory analgesics and muscle relaxants. The muscle relaxants using in general are tolperisone hydrochloride, chlormezanone, and diazepam. Eperizone hydrochloride(Mulex tablet) is a beta-propriophenone derivatives and a central acting muscle relaxant, And it benefited subjective symptoms such as muscular pain (lumbago, neck pain) and a stiff muscle sensation (shoulder tension, tension feeling of lower limb). Among 22 patients, there were 14 lumbagos, two cephalobrachial syndromes, one scapulohumeral periarthritis, and five combined patients were chosen and duration of symptom was 5 years (3months-15years) in average. Mulex tablet was administered in a dose of 3 tablets (150rag) per day in 22 patients for 6 weeks prospectively. We analysed general improvement rating (GIR), general usefulness rating(GUR), and overall safety rating. The general improvement rate was 78% and the aggravation rate was 4%. The complication after, madication was infrequently gastrointestinal trouble. Incidence of side effect was 22%, but all these complications were insignificant. Hematology, blood chemistry, and urinalysis after medication were normal.
Analgesics ; Chemistry ; Chlormezanone ; Diazepam ; Hematology ; Humans ; Incidence ; Low Back Pain ; Myotonia ; Neck ; Periarthritis ; Prospective Studies ; Sensation ; Tablets ; Tolperisone ; Urinalysis