Objective: The aim: In this study, we present a sub-analysis of physical functionality in sufferers of mild knee osteoarthritis (OA) following a clinical assessment of a novel nutraceutical supplement Tregocel® complementary to standard treatment.
Patients and methods: Materials and methods: We evaluated the results of a multicenter, open-label, single-arm efficacy and safety evaluation of a polyherbal nutraceutical, performed in subjects with symptomatic, mild knee OA (n = 107, 59.7 ± 10.8 yrs, 68.2% female) over 36 weeks. Physical function was assessed using a standardized walking challenge (6-min walk test), combined with WOMAC indices and leg flexion measurements. Sub-analysis was performed using a linear mixed model that tracked changes in the walking challenge outcomes over time, adjusted for age, gender, and OA duration.
Results: Results: Walking distance was significantly improved with the duration of nutraceutical use, increasing by 0.72 m (95% CI: 0.56, 0.88) per week of product administration. Similarly, there were significant decreases in WOMAC indices per week for stiffness (-1.6, 95% CI: -1.8, 1.4), daily functioning (-13.5, 95% CI: 14.9, 11.9) and global outcome (-19.2, 95% CI -21.3 - -17.1). Furthermore, supine heel-to-high flexion distance was improved relative to the duration of nutraceutical use.
Conclusion: Conclusions: The use of a polyherbal nutraceutical resulted in clinical improvements in several indices of physical functioning in mild knee OA suffers. Trial registration: NCT03636035.
Keywords: 6-minute walk test; WOMAC; curcuminoids; heel-thigh distance flexion test; osteoarthritis.