4.4. Outcome Measures
Osteoarthritis, Pain, Knee injury, knee stiffness, pain, 3.1)—pain, knee pain, NRS
ADVERSE EVENTS, OSTEOARTHRITIS
Patients were prospectively evaluated at baseline and then at 1, 3, and 6 months after the last injection. As the primary outcome was to compare the effectiveness of the two treatments, changes in knee pain were investigated through the WOMAC using the Likert scale, Version 3.1 (WOMAC LK 3.1)—pain subscale [The WOMAC LK 3.1 is a validated tool used for assessing knee pain, stiffness, and function. It is composed of 24 items: 5 assessing knee pain, 2 assessing knee stiffness, and 17 assessing physical function. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. NRS is a validated measure of knee pain. It is an 11-point Likert-type scale anchored by 0 “no pain” and 10 “worst possible pain”. Subjects rate their average pain over the last 48 h. The Knee injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument developed to assess the patient’s opinion about their knee and associated problems. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL); Function in Sport and Recreation (Sport/Rec); and knee-related Quality of Life (QOL).Lastly, we assessed the safety by considering the number of adverse events. To guarantee the double-blinding of the trial, all the clinical evaluations were performed by an independent physician not involved in the injection procedure.