Long-term effects of intra-articular oxygen-ozone therapy versus hyaluronic acid in older people affected by knee osteoarthritis: A randomized single-blind extension study
Affiliations: [a] Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont “A. Avogadro”, Novara, Italy | [b] Rehabilitation Unit, “Mons. L. Novarese” Hospital, Moncrivello, Vercelli, Italy | [c] Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy | [d] Physical Medicine and Rehabilitation Unit, University Hospital “Maggiore della Carità”, Novara, Italy
Correspondence:
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Corresponding author: Alessandro de Sire, Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont “A. Avogadro”, Viale Piazza D’Armi, 1 – 28100 Novara, Italy. Tel.: +39 3213734800; E-mail: [email protected].
Abstract: BACKGROUND: There is little evidence on intra-articular (IA) treatment in knee osteoarthritis (KOA) and there is a lack of long-term follow-up studies. OBJECTIVE: To assess the long-term effectiveness and safety of IA oxygen-ozone (O2O3) and hyaluronic acid (HA) in terms of functioning in KOA patients over a 31-week period. METHODS: Patients aged ⩾ 60 years with KOA were randomly allocated to receive 4 IA knee injections (1/week) of O2O3 or HA (T0–T3) and a follow-up visit 4 weeks after the fourth injection (T4). In this extension study we assessed VAS and safety in patients with Visual Analogue Scale (VAS) ⩾ 4 at the at 6-month follow-up visit (T5), undergoing a second treatment cycle (T5–T8) and 1-month follow-up visit (T9). RESULTS: Forty-two patients (aged 70.5 ± 5.8 years) were randomly allocated to O2O3 (n= 22) or HA group (n= 20). Twenty-three underwent another IA cycle: 12 (54.6%) in the O2O3 group and 11 (55.0%) in the HA group. Both groups showed significant reduction in VAS (p< 0.013) compared to baseline during both cycles. At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013). There were no differences in adverse events occurrence between groups. CONCLUSIONS: IA O2O3 might be comparable to HA in terms of effectiveness and safety in reducing pain in KOA patients, although at both follow-up visits (T4 and T9) VAS was significantly lower in the HA group.
