International Journal of Physical Medicine & Rehabilitation
Open Access
ISSN: 2329-9096
+44 1300 500008
ISSN: 2329-9096
+44 1300 500008
Amit Bhalla
Cadila Healthcare Ltd., India
Posters & Accepted Abstracts: Int J Phys Med Rehabil
Objective: To evaluate the efficacy and safety of topical Diclofenac with Heparin (Diclofenac sodium 1% and Heparin 200 IU w/w ) gel in subjects with acute blunt and soft tissue injuries. Design: Open labelled, non-comparative multicenter study. Setting: 25 study centers in India. Participants: 296 patients with acute blunt and soft tissue injuries like sports injury, sprain and strain, frozen shoulder and knee pain. Interventions: Diclofenac with Heparin topical gel was applied t.i.d. for ΓΆΒ?Β¥48 hours up to 7 days. Main Outcome Measures: The efficacy assessment of treatment was done based on the overall symptoms of soft tissue injury. The efficacy parameters for this evaluation are: pain of movement (POM), inflammation, haematoma, pain on leaning of injured limb, oedema, swelling, redness and overall pain. A 3-point scoring data was obtained for all these efficacy parameters for Baseline (BL) and End of therapy (EOT), where 0 indicates no symptoms and 3 indicates severe symptoms. Statistical Analysis: Non-parametric Wilcoxon signed-rank test was applied on the data of difference between BL and EOT symptoms scores. Results or Clinical Course: Patients treated with topical Diclofenac and Heparin gel experienced significantly greater reduction in POM at EOT (p<.0001). For all injury cases, there was a significant difference at 5% level of significance (p < 0.05), which gives evidence that there is a significant decrease in the symptoms of soft tissue injury for all the efficacy parameters. Conclusions: Diclofenac with Heparin topical gel applied 3 times daily was a safe and highly effective treatment for the symptoms of blunt and soft tissue injuries, and it could represent a new option for the treatment of acute blunt trauma and other soft tissue injuries.
Email: amitbhalla@zyduscadila.com