Health Condition 1: null- In acute nonspecific Low back painful condition
Conditions
Interventions
Intervention1: Topical solution of Diclofenac plus Thiocolchicoside: 4 times a day for 7 days
Control Intervention1: Diclofenac Gel: 4 times a day for 7 days
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male of Female patients aged 18-60 years 2. Non specific low back pain with an acute episode of recent onset(less than 48 hours) defined by average pain within the last 24 hours equal or more than 5 on the Visual Analogue Scale (VAS) 3. Low back pain of diagnostic category 1( low back pain radiating no farther than the intergluteal fold) or 2 ( low back pain radiating no farther than the knee) as defined by the International Paris Task Force on Back Pain 4. Patients who are willing to take medications as directed, to come for follow ups, to give written consent and comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination)such as neoplasm, infection or inflammatory disorders. 2. Low back pain of diagnostic category 3( low back pain radiating beyond the knee with no neurologic signs)or 4( low back pain radiating to a precise and entire leg dermatome with or without neurologic signs) as defined by the International Paris Task Force on Back pain. 3. History of Inflammatory arthritis of Large Joints, or any structural deformity. 4. History of seizure disorder, or any recent history of violent trauma, psychiatric or mental diseases or any widespread neurological symptoms. 5. History of malignant tumor. 6. Patient who have received other therapy [NSAIDs( including aspirin), muscle relaxant or opioid analgesics, physiotherapy, physical manipulations, invasive intervention, accupuncture therapy] within last 48 hours. 7. History of Immunosuppression, HIV or use of immunosuppressive drugs. 8. Inclusion in another study in past 6 months or previous inclusion in this study. 9. History of alcohol, drug or narcotics abuse. 10. Constant progressive, non mechanical pain(no relief with bed rest) 11. Thoracic pain 12. Patient systemically unwell or having fever, or unexplained weight loss. 13. Clinically significant renal dysfunction/ hepatic dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief with study medicationTimepoint: On Day 3 (telephonic follow up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Analgesic scores. 2.Severity of Pain,Local tenderness, Degree of functional impairement. 3. Total Analgesia using Rolland Morris Disability Questionnaire 4. Physicians & Patients Global AssessmentTimepoint: 1. Day 3 (Telephonic follow up) and day 7 (End of the study treatment). 2. Day 7 (End of the study visit). 3. Baseline and Day 7 (End of the study Visit). 4. Day 7 (End of the Study Visit) | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Troikaa Pharmaceuticals Ltd.
Outcome results
None listed