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To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiocolchicoside | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During patient visits: day 1, day 3 and day 5 to 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor). | During patient visits: day 1, day 3 and day 5 to 10 | |
| Disability Questionnaire (Roland Morris) | During patient visits: day 1, day 3 and day 5 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manish MISTRY | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Mumbai | India |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C004280 | thiocolchicoside |
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| Physician rated Clinical Global Impression Scale | During patient visits: day 1, day 3 and day 5 to 10 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |