Acute Lumbago Musculoskeletal Diseases Pain
Conditions
Interventions
Group one - intervention treatment: Aceclofenac injection 150 mg twice daily (b.i.d) for two days.
Group two - intervention treatment: Diclofenac injection 75 mg b.i.d for two days.
Sponsors
Venus Remedies Limited (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of either sex, aged over 18 years suffering from acute lumbago (that began less than 48 hours before study entry) 2. Pain intensity more than 50 mm on a 100 mm Visual Analogue Scale (VAS)
Exclusion criteria
Exclusion criteria: Patients with history of: 1. Recurrent peptic ulcer or duodenal ulcer 2. Gastrointestinal bleeding or other bleeding disorders 3. Significant renal or hepatic impairment 4. Any significant abnormality on preclinical trial screening 5. Pregnant and lactating mothers 6. Patients requiring aspirin at any dose, corticosteroids, anticoagulants, ticlopidine hydrochloride or other drugs affecting platelet function and coagulation, and patients taking hormonal contraceptives or patients allergic to Non Steroidal Anti-Inflammatory Drugs (NSAIDs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of overall response to study drugs. 2. Assessment of overall response of subjects to the drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in VAS pain at 30 minutes, one, two, four, eight, 24 and 48 hours after the treatment compared with the baseline. 2. Assessment to degree of improvement after eight hours, 24 hours and 48 hours of treatment compared to baseline in: a. pain on movement using a four point scale b. functional impairment using a four point scale c. pain on pressure in the lumbosacral region using a four point scale d. muscle contraction in the lumbosacral region using a four point scale | — |
Countries
India
Outcome results
None listed