RESUMO
INTRODUCTION: Knee osteoarthritis (OA) is a prevalent degenerative musculoskeletal condition, affecting approximately 277 million people worldwide, with significant impacts on mobility, especially in women and obese patients, and an increasing incidence among Indians aged 30 to 50 years. The primary objective was to evaluate the knee muscle-strengthening effect of Myostaal® liniment (Solumiks Herbaceuticals Limited, Mumbai, India) as an add-on to physiotherapy for 90 days compared to physiotherapy alone in participants with knee OA. Secondary objectives included assessing changes in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, WOMAC Subscale scores, Six-Minute Walk Test (6MWT) distance, Single Leg Stance Test (SLST) duration, Visual Analogue Scale (VAS) score, and the number of adverse events from baseline to Day 90 between the two groups. METHODS: Seventy participants were randomly allocated to Group A (Myostaal® liniment plus physiotherapy) or Group B (physiotherapy alone) for 90 days, with Myostaal® liniment applied twice daily in Group A. Data were recorded in Case Report Forms (CRFs) and analyzed using parametric tests for within-group comparisons (one-way ANOVA or Friedman test) and non-parametric tests (Mann-Whitney test) for between-group comparisons, with significance set at p<0.05. RESULTS: The knee muscle strength (index knee) in Group A (test medication group) was significantly greater compared to Group B (standard treatment group) at Visit 3 (p<0.05; Day 60±3) and Visit 4 (p<0.001; Day 90±3). For the non-index (other) knee, a statistically significant increase in knee muscle strength was observed (p<0.001 at Day 90±3) solely in Group A. A notable reduction in total WOMAC score was seen in Group A from Visit 2 (p<0.01; Day 30±3) onward, compared to Visit 1 (Day 0). The scores at Visit 3 (p<0.001; Day 60±3) and Visit 4 (p<0.001; Day 90±3) were significantly lower than those at Visit 2 (Day 30±3). CONCLUSION: The local application of Myostaal® liniment through massage as an adjunct to a physiotherapy regimen, improved knee muscle strength in participants with knee OA, leading to an enhancement in joint functionality. Additionally, Myostaal® liniment provided superior pain relief as an add-on therapy.