Background Ankle sprains are among the most common of all sports injuries, with approximately two million people per year seeking for medical treatment.1 The emphasis of therapy in ankle sprains is focused on reducing the inflammation and pain rapidly following injury.2 Sodium Hyaluronate (SH) is a natural biological substance which has proven to be effective on viscosupplementation therapy for osteoarthritis in different joints.3 As it relieves pain and stiffness, the administration of periarticular injections of SH was proposed to treat ankle sprain.4
Objectives To evaluate the efficacy and safety of a single periarticular injection with SH in the treatment of lateral ankle sprain.
Methods A single-site, and non-controlled trial was conducted in patients with an acute grade 1 or 2 lateral ankle sprain. Patients received at baseline (within 48 hours of injury) a single 2.5ml periarticular injection with SH (manufactured by Tedec Meiji Farma SA) plus standard of care (RICE: Rest, Ice, Compression and Elevation). Efficacy assessments were done at baseline and days 8, 30 and 90 and included VAS (0-100mm) pain on weight bearing and walking 20m, patient's/physician's global assessment of ankle injury (5-point categorical scale), patient's assessment of return to normal activity in sport (5-point categorical scale), patient's/physician satisfaction with treatment (10-point categorical scale) and time to return to pain-free and disability-free sport. Adverse events were recorded for safety purposes.
Results A total of 31 patients were included and completed the study. Most signs of pain, swelling and disability were adequately controlled after only 8 days post-injection. A statistically significant reduction from baseline in VAS pain on both weight bearing and walking was observed at 8, 30 and 90 days (p<0.05). Regarding remaining efficacy variables, a statistically significant improvement was achieved at all time points compared to baseline. Satisfaction with treatment was very high for both the patient and the physician throughout the study. Return to pain and disability-free sport was observed in 52% of patients at day 8, 84% at day 30 and 100% at day 90. A number of 2 adverse events were reported and consisted in pain at injection site at day 1. No serious adverse events were recorded.
Conclusions A single periarticular injection of SH showed significant reduction in pain, improved mobility and was highly satisfactory. This was associated with a rapid return to sport and with no safety concerns.
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Disclosure of Interest : P. Coronel Employee of: Tedec Meiji Farma SA, Spain, M. Gimeno Employee of: Tedec Meiji Farma SA, Spain, R. J. Petrella Grant/research support: Research support fromTedec Meiji Farma SA, Spain