Knee osteoarthritis (KOA) is one of the most common public health problems which cannot be cured and ultimately leads to disability. Current management is largely limited to the treatment of the symptoms. To avoid the late stages of KOA that lead to knee replacement, the key point is to control and reduce destructive processes using efficient pharmacological products combined with physiotherapy (PT). Herein, we perform a monocentric observational study to compare the effect of combining a multi-modal physiotherapy regime and intra-articular (IA) injection with hyaluronic acid (HA) on the non-surgical treatment of KOA. Patients with mild KOA were randomly assigned to two groups to receive an HA injection with PT or an HA injection only. The assessment tools for pain, clinical disease severity, and disability were the total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (scores range from 0 to 96, with higher scores indicating worse pain, function, and stiffness), knee range of motion (ROM), pain on the visual analog scale (VAS), and muscle strength testing (MST). All tests were evaluated every 3 months up to 1 year from the baseline. The study enrolled 52 patients with ages between 47 and 61 years who were divided into two groups. Thirty-seven (n = 37) patients were randomized in the pilot group (PG) and received IA injections with the viscoelastic hyaluronic acid product (HA) combined with a multi-modal PT regime. The PT program included 10 sessions of transcutaneous electrical nerve stimulation, low-level laser therapy, ultrasound, physical exercise, and cryotherapy. Fifteen patients (n = 15) from the control group (CG) received the IA HA injections only. All patients were confirmed with mild KOA of Kellgren–Lawrence grade 2 on radiographs at the beginning of the treatment. The baseline characteristics, including the severity of pain and level of disability, were similar in the two groups. At baseline, the mean (±SD) WOMAC scores reported were 64.6 ± 4.08 in the CG and 64.5 ± 2.99 in the PG. Notably, at only 3 months into the study, the mean scores were significantly improved to 56.7 ± 5 in the CG and 48.27 ± 2.13 in the PG (mean between-group difference = 16.19 points; 95% confidence interval), finding favor for the combination of HA injections and physiotherapy. At the study’s endpoint (12 months), the scores were improved in both groups, with the mean between-group difference remaining significant (7.08 points, 95% confidence interval). A decrease in pain, as evaluated by the VAS scale, was reported for both groups, with the PG reporting a better VAS score that decreased from 5.7 to 2 when compared to the CG, which decreased from 5.7 to 3. The physical assessment parameters (ROM and MST) followed the same trend, with a rapid improvement in the ROM in the PG, changing from 98° to 115° in the first 3 months, and a slower and more steady evolution in the CG group, changing from 100° to 112° in 9 months. Herein, we report on the combination therapy of an intra-articularly administered HA viscoelastic product and a multi-modal physiotherapy regime, which can play a key role in the non-surgical treatment of KOA, effectively controlling pain, stiffness, and the ROM value and improving patients’ quality of life.
