Background Lateral elbow epicondylitis, also known as tennis elbow, is a common musculoskeletal condition causing pain and functional impairment in daily activities.1 It affects between 40–50% of recreational tennis players at some time.2 Sodium Hyaluronate (SH) is a natural biological substance which has proven to be effective to improve pain and function in osteoarthritic patients with low incidence of side effects.3 Similarly, the administration of periarticular injections of SH can be an alternative approach to treat chronic epicondylitis.4
Objectives To evaluate the efficacy and safety of a single periarticular injection with SH in the treatment of epicondylitis.
Methods A single-site, and placebo-controlled trial was conducted in patients with chronic epicondylitis. Patients' condition was assessed at baseline and afterwards they were randomized 1:1 to receive a single 2.5ml injection of SH (manufactured by Tedec Meiji Farma SA) or placebo (saline) at the point of maximal pain at the lateral epicondyle. Additionally, standard of care (RICE: Rest, Ice, Compression and Elevation) was prescribed to both groups. Efficacy assessments were done at days 30 and 90 and included VAS (0–10cm) pain at rest and assessment of grip strength, patient global satisfaction, patient assessment of normal function and physician global assessment of elbow injury (all measured using 5-point categorical scale). Adverse events were recorded for safety purposes.
Results A total of 60 patients were included and completed the study procedures. Both groups were homogeneous at baseline. A statistically significant reduction from baseline in VAS pain at rest and after grip testing was observed at 30 and 90 days in both treatment groups (p<0.05). Besides, inter-group comparison showed statistically significant differences in favour of SH group at 30 and 90 days (p<0.05). This was associated with significantly greater grip strength, patient global satisfaction and assessment of normal elbow function in SH group vs placebo (p<0.05). Improvement of elbow injury assessed by the physician was also statistically greater in patients treated with SH compared to placebo (p<0.05). No adverse events were recorded.
Conclusions A single local injection of SH administered to patients with epicondylitis was significantly superior to placebo improving pain at rest and after grip testing, through all the study follow up period. The treatment was highly satisfactory for both physicians and patients and there were no safety concerns.
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Disclosure of Interest None declared