A multiple centre study to check the efficacy and safety of Topical formulation of Diclofenac plus Thiocolchicoside in comparison with Diclofenac gel in acute low back pain.

Phase 3

Completed

• Conditions: Health Condition 1: null- In acute nonspecific Low back painful condition

• Registration Number: CTRI/2011/11/002116
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified