Investigation of the efficacy and safety of ultrasound-standardized autologous blood injection as treatment for lateral epicondylitis

BACKGROUND: There are various conservative treatment options for lateral epicondylitis (LE). The aim is to evaluate pain, daily functioning, and complications after ultrasound-standardized autologous blood injections in patients with LE. METHODS: For this prospective cohort study, consecutive patients (>18 years) diagnosed with LE were included. Autologous blood was injected using a medical device containing an injection disposable with 12 small needles (Instant Tennis Elbow Cure [ITEC]) device. Patient-Rated Tennis Elbow Evaluation (PRTEE), subjective elbow score (SES), palpation and provocation pain, satisfaction, and complications of treatment were measured at baseline and two months after treatment. Paired t-tests and Fisher’s exact tests were used for calculating the difference between pre- and post-treatment outcomes. RESULTS: Fifty-five elbows were analyzed. Mean time between pre- and post-treatment was 11.1 weeks (standard deviation [SD], 8.9 weeks). The mean PRTEE score decreased from 68.2 (SD, 15.7) before surgery to 53.2 (SD, 25.9; p<0.001) after. The mean SES improved from 36.9 (SD, 20.8) to 51.7 (SD, 27.4; p<0.001). Despite this improvement, only 44.7% of patients showed relevant clinical improvement in PRTEE, and 37.3% showed significant clinical improvement based on SES. Four patients reported a complication and the injection disposable failed three times. CONCLUSIONS: Ultrasound-standardized autologous blood injection using the ITEC device is not an effective tool in reducing symptoms related to LE. This study showed that only half of all patients experienced a positive effect. In this heterogeneous cohort of patients, we showed no added value of ultrasound standardization.