Effectiveness and tolerability of FreeFlextrade; Emulgel in the treatment of osteoarthritis: A prospective, multi-center, real world evidence study

Background: Osteoarthritis (OA) is a common, debilitating condition affecting over 62 million people in India. Current treatments, including pharmacological and surgical interventions, are associated with significant side effects and high costs, highlighting the need for safer, more accessible alternatives. This study aimed to evaluate the effectiveness and tolerability of FreeFlex™ Emulgel, a topical formulation containing glucosamine sulfate, chondroitin sulfate, curcumin, Boswellia serrata, ginger, wintergreen oil, and menthol, developed with VesiFuze™ technology to enhance skin permeability. Methods: A total of 708 knee OA patients were enrolled in this prospective, multicentre study, with 667 completing the 28-day treatment period. Patients applied FreeFlex™ Emulgel twice daily on the affected knee. Pain was assessed using the Visual Analog Scale (VAS) at baseline and day 28. Physicians' and patients' global assessments of treatment efficacy were recorded on day 28. Results: The study showed a significant reduction (p-value < 0.0001, 95% CI: 3.23 – 3.82)) in VAS scores from 6.97 + 2.5 at baseline, which improved significantly to 3.45 + 2.44 at the end of treatment, indicating a 49.4% improvement in pain levels. Additionally, 93% of patients reported being “Very Satisfied” or “Satisfied” with the treatment, and 82% of physicians noted significant improvements in their assessments. Conclusion: FreeFlex™ Emulgel demonstrated significant efficacy in reducing OA pain and improving joint function, providing a well-tolerated and effective alternative/add-on to oral medications.