Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
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Pain score evaluated by patient-rated visual analog scale: the levels of spontaneous pain is indicated by the patient by means of a 10 centimetre non-graduated scale, in which the patient could estimate the intensity of pain [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ]
Secondary Outcome Measures :
Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor). [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ]
Disability Questionnaire (Roland Morris) [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ]
Physician rated Clinical Global Impression Scale [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of acute low back pain of recent onset (less than 7 days) and defined by spontaneous pain intensity at rest more than or equal to 50mm of the visual analog scale.
Presence of lumbar muscular contracture
Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
Renal failure (serum creatinine > 160 µmol/l or > 1.80 mg/dl) and/or severe hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase and/or total bilirubin > 2 Upper normal limit).
Positive history of cerebro-vascular accidents or myocardial infarction in the six months prior the inclusion.
Severe heart failure.
Myopathy / myasthenia.
Patients treated during two days prior to inclusion with steroidal agents.
Known or suspected hypersensitivity to thiocolchicoside.
Known or suspected hypersensitivity to nonsteroidal anti-inflammatory drugs
History of active peptic ulcer or gastro intestinal bleeding.
History of nonsteroidal anti-inflammatory drugs induced allergic asthma.
Concomitant treatment with 2-agonists (i.e. clonidine).
Pregnant or breast feeding women.
Females of child bearing potential, not taking adequate contraception.
Patients with history of alcohol, drugs or narcotics abuse.
Previous inclusion in this study or in another study in the past 6 months.