1. Introduction
OA-related, OA, shock, osteoarthritis, pain, multiple musculoskeletal disorders, degenerative disease, OA.Osteoarthritis, reduced motor function, joint stiffness, NRS
ADVERSE EVENTS, OSTEOARTHRITIS, MUSCULOSKELETAL DISORDERS, SHOCK
Ozone therapy (OT) is used for the treatment of multiple musculoskeletal disorders. In recent years, there has been a growing interest in its use for the treatment of osteoarthritis (OA). The aim of this double-blind randomized controlled trial was to evaluate the efficacy of OT compared with hyaluronic acid (HA) injections for pain relief in patients with knee OA. Patients with knee OA for at least three months were included and randomly assigned to receive three intra-articular injections of ozone or HA (once a week). Patients were assessed at baseline and at 1, 3, and 6 months after the injections for pain, stiffness, and function using the WOMAC LK 3.1, the NRS, and the KOOS questionnaire. Out of 55 patients assessed for eligibility, 52 participants were admitted to the study and randomly assigned into the 2 groups of treatment. During the study, eight patients dropped out. Thus, a total of 44 patients, reached the endpoint of the study at 6 months. Both Group A and B consisted of 22 patients. At 1-month follow-up after injections, both treatment groups improved statistically significantly from baseline in all outcomes measured. At 3 months, improvements remained similarly consistent for Group A and Group B. At 6-month follow-up, the outcomes were comparable between the 2 groups, showing only a worsening trend in pain. No significant differences were found between the two groups in pain scores. Both therapies have proven to be safe, with the few recorded adverse events being mild and self-limiting. OT has demonstrated similar results to HA injections, proving to be a safe approach with significant effects on pain control in patients affected by knee OA. Due to its anti-inflammatory and analgesic effects, ozone might be considered as a potential treatment for OA.Osteoarthritis (OA) of the knee is a widespread degenerative disease that causes pain, joint stiffness, and reduced motor function [There are currently no approved treatments that can slow OA-related structural progression, so the main goals of conservative treatment are to provide symptomatic pain relief, improve joint function, and delay surgery [Several minimally invasive strategies, such as intra-articular (IA) injections, have been shown to be well tolerated and able to provide good clinical results [These treatments are of particular interest because they could provide specific actions on the pathogenic biochemical mechanisms previously described. Hyaluronic acid (HA) injections are known to improve mechanical properties of the joint such as shock absorption, lubrication, and cartilage protection [Furthermore, recent studies have shown that HA may also have a regenerative role at the bone level. HA appears to be able to promote an enhancement of the osteogenetic effect of BMP-2 through the activation of a pathway involving the Smad family of proteins and the downregulation of certain BMP-2 antagonists (noggin and follistatin) [There is a large body of evidence that has confirmed HA efficacy in the management of knee OA [OT is commonly used in the management of a variety of musculoskeletal disorders, mainly for its analgesic, anti-inflammatory, immunomodulatory, and trophic properties [The aim of the present double-blind randomized controlled trial (RCT) was to compare the clinical outcomes at 6 months follow-up of IA OT versus HA injections for the treatment of knee OA. Our hypothesis was that OT might provide symptomatic relief and functional improvement at least comparable to that of HA.