Alessandro de Sire1,2, Davide Stagno1, Marco Alessandro Minetto3, Carlo Cisari1,4, Alessio Baricich1,4, Marco Invernizzi1. 1. Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont "A. Avogadro", Novara, Italy. 2. Rehabilitation Unit, "Mons. L. Novarese" Hospital, Moncrivello, Vercelli, Italy. 3. Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy. 4. Physical Medicine and Rehabilitation Unit, University Hospital "Maggiore della Carità", Novara, Italy.
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.
RCT Entities:
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 IAoxygen-ozone (O2O3) and hyaluronic acid (HA) in terms of functioning in KOApatients 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:IAO2O3 might be comparable to HA in terms of effectiveness and safety in reducing pain in KOApatients, although at both follow-up visits (T4 and T9) VAS was significantly lower in the HA group.
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