OBJECTIVES: Numerous clinical evidences support the treatment of knee OA (KOA) with oral formulations based on hyaluronic acid (HA) and chondroitin sulfate (CS). The formulation aim of the present study (IA) combines a hydrolyzed low molecular weight collagen matrix providing high content of depolymerised HA and CS, with methylsulfonylmethane (MSM), Manganese and a milk glycoprotein. The goal was to evaluate whether combined treatment with intra - articular injection of HA and AI is more effective than treatment with HA only for the symptomatic treatment of knee OA. MATERIALS AND METHODS: Randomized, double-blind, placebo-controlled clinical trial. Patients (nr = 100), after undergoing an intra-articular injection with HA, were randomized to receive IA or placebo for 3 months. The efficacy of the treatment was assessed by measuring at baseline, 1 and 3 months, the values of the VAS pain scale, the Knee injury and Osteoarthritis Outcome Score, the Tegner Lysholm Knee Scoring Scale, Lequesne algofunctional index and the consumption of NSAIDs and analgesics. RESULTS: The treatment group HA + IA showed a positive trend compared to the group treated with HA only for all the efficacy variables observed, in particular regarding the VAS and the analgesic consumption. CONCLUSIONS: The evidences obtained in this study point out that the oral viscosupplementation with the formulation aim of the present study (IA) represents a valuable, manageable, effective and well tolerated aid, useful to maintain and extend the benefits obtained with intra - articular injection of HA, helping to significantly reduce the use of painkillers by patients.
RCT Entities:
OBJECTIVES: Numerous clinical evidences support the treatment of knee OA (KOA) with oral formulations based on hyaluronic acid (HA) and chondroitin sulfate (CS). The formulation aim of the present study (IA) combines a hydrolyzed low molecular weight collagen matrix providing high content of depolymerised HA and CS, with methylsulfonylmethane (MSM), Manganese and a milk glycoprotein. The goal was to evaluate whether combined treatment with intra - articular injection of HA and AI is more effective than treatment with HA only for the symptomatic treatment of knee OA. MATERIALS AND METHODS: Randomized, double-blind, placebo-controlled clinical trial. Patients (nr = 100), after undergoing an intra-articular injection with HA, were randomized to receive IA or placebo for 3 months. The efficacy of the treatment was assessed by measuring at baseline, 1 and 3 months, the values of the VAS pain scale, the Knee injury and Osteoarthritis Outcome Score, the Tegner Lysholm Knee Scoring Scale, Lequesne algofunctional index and the consumption of NSAIDs and analgesics. RESULTS: The treatment group HA + IA showed a positive trend compared to the group treated with HA only for all the efficacy variables observed, in particular regarding the VAS and the analgesic consumption. CONCLUSIONS: The evidences obtained in this study point out that the oral viscosupplementation with the formulation aim of the present study (IA) represents a valuable, manageable, effective and well tolerated aid, useful to maintain and extend the benefits obtained with intra - articular injection of HA, helping to significantly reduce the use of painkillers by patients.