Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial

Objective: Methodological constraints weaken previous evidence on intra‐articular viscosupplementation and physiological saline distention for osteoarthritis. We conducted a randomized, patient‐ and observer‐blind trial to evaluate these interventions in patients with painful knee osteoarthritis.Methods: We centrally randomized 251 patients with knee osteoarthritis to four weekly intra‐articular injections of sodium hyaluronate 2 mL (Hyalgan® 10.3 mg/mL) versus physiological saline 20 mL (distention) versus physiological saline 2 mL (placebo) and followed patients for 26 weeks. Inclusion criteria were age over 59 years and daily knee pain more than 20 mm on a 100‐mm visual analogue scale (VAS) without satisfactory response to analgesics. During the trial, rescue analgesic were allowed. The primary outcome was pain on movement. The secondary outcomes were pain at rest, pain during the night, Knee Injury and Osteoarthritis Outcome Score (KOOS), Osteoarthritis Research Society International (OARSI) criteria,...