Introduction. Knee osteoarthritis (gonarthrosis) of different etiology is the most common age-related joint disease affecting over 80% people beyond 55 years of age. The use of hyaluronic acid “replacement” intraarticular injections is the priority method for treating gonarthrosis. Implants with human synovial fluid containing hyaluronic acid with a concentration of 10 mg/ml are the most commonly used therapy in world practice.Objective of the study: compare the efficacy of RIPART hyaluronic acid, 3.0 ml (Ingal LLC, Russia) and the standard Mucosat chondroprotector therapy (chondroitin sodium sulfate 100 mg, Russia) in patients with degree 1–3 gonarthrosis in the outpatient setting.Materials and methods. A total of 90 patients with degree 1–3 gonarthrosis were included in the study. The patients had not previously received any treatment with Mucosat chondroprotector and RIPART hyaluronic acid. The drugs for the treatment of patients with gonarthrosis were selected in accordance with the clinical guidelines for the management of osteoarthritis, taking into account the age and comorbidity of patients. Of the non-steroidal anti-inflammatory drugs, Nimesulide, 100 mg was selected at a standard dosage of 200 mg/day for 14 days, followed by reduction of the dose to 100 mg/day for a period of 14 days to 1 month. Mucosat was used as a chondroprotector in two comparison groups No. 1 and No. 3 (n = 60) at a dose of 2.0 ml intramuscularly No. 30 ampoules every other day for 8 weeks. In comparison groups No. 2 and No. 3, a local injection of RIPART 3.0 hyaluronic acid preparation was made into the knee joint (a single injection per week, 3 in total). In comparison group No. 3 (n = 30), the patients with degree 1–3 gonarthrosis received a combined course of local therapy with RIPART 3.0 No. 3 hyaluronic acid and Mucosat injection IM.In addition to clinical examination, the time required for an individual to climb the 10-step stairs and the time required for an individual to walk the 30-m distance were used to assess the effectiveness of treatment (с). The knee joint volume was measured using a centimeter tape in the middle third of the joint, the knee range of motion was measured with electrogoniometers, the joint swelling was assessed in points (0 to 2 points), pain during palpation along the joint gap was assessed in points (0 to 2). The pain level was assessed using a visual analogue scale, and the functional WOMAC index and Leken index were determined based on the patient-reported outcomes.Results. In study group No. 1 (nimesulide + Mucosate), 30 patients with degree 1–2 gonarthrosis received nimesulide and Mucosate therapy for 6 months, which resulted in the reduction of pain on a visual-analogue scale on Days 8–9. After 6-month observation, the level of pain on the visual analogue scale in patients with degree 1–2 gonarthrosis did not exceed 20–25 mm, in patients with degree 3 gonarthrosis, the pain level on the pain visual analogue scale did not reduce less than 35–40 mm. The Leken index decreased to 2 points in degree 1–2 gonarthrosis and to 5 points in degree 3 gonarthrosis.In comparison group No. 2, the effectiveness of local RIPART hyaluronic acid therapy exceeded the indicators in group 1, which made itself evident in the fact that pain decreased on a visual-analogue scale after the first knee joint injection in patients with degree 1 and 2 gonarthrosis and resulted in a decrease of nimesulide doses on Day 2–3 followed by its cancellation. Local RIPART hyaluronic acid therapy in patients with degree 3 gonarthrosis resulted in the reduction of nimesulide dose on Day 22 after the third knee joint injection.After 6-month observation, the level of pain did not exceed 20–25 mm on the pain visual-analogue scale in patients with degree 1–2 of gonarthrosis and did not decrease less than 35–40 mm on the pain visual-analogue scale in patients with degree 3 gonarthrosis. The Leken index decreased to 5 points.In comparison group No. 3, the combined treatment “nimesulide + Mucosat + RIPART” in 30 patients with degree 1–3 gonarthrosis showed a significant and noticeable reduction in pain to 15–20 mm on the visual-analogue scale in degree 1–2 gonarthrosis and to35 mmin degree 3 gonarthrosis, the Leken index decreased to 1–2 and 5–6 points, respectively.Patients with degree 3 gonarthrosis continued to administer nimesulide at a dose of 200 mg/day for 21–23 days, followed by switching to on-demand therapy during the entire observation period (before exercise, after exercise). The pain level on the visual analogue scale in patients with degree 3 gonarthrosis decreased on day 20–23 from the baseline figures of 80–85 mm to 35–40 mm; the relapse rate of pain and reactive synovitis decreased. In patients with degree 1–2 gonarthrosis, nimesulide was cancelled on Day 8, pain level after 6 months did not exceed 15–20 mm on the visual-analogue scale. Changes in the Leken index and WOMAC index correlated with an indicator of pain level of the visual analogue scale.Conclusions. The study findings showed that the outpatient local therapy with RIPART hyaluronic acid combined with Mucosat chondroprotector and a short course of nimesulide as non-steroidal anti-inflammatory drugs may be recommenced as the preferred treatment method compared to the prescription of any of the chondroprotectors in degree 1–3 gonarthrosis.
Is the Pain Visual Analogue Scale Linear and Responsive to Change? An Exploration Using Rasch Analysis
