Corticosteroids vs autologous blood injection for lateral epicondylitis: Study protocol for a cohort trial

BACKGROUND: There is limited evidence to assess the evaluation of the safety and effectiveness of autologous blood injections in the treatment of lateral epicondylitis patients. For this study, the aim was to compare the efficiency of corticosteroid and autologous blood injections for the treatment of lateral epicondylitis in a retrospective cohort trial in our single center. METHODS: After being approved by the institutional review committee of Chongqing General Hospital (IRB# 2018.417.C, November 9, 2018), we performed a single-center, retrospective study between November 2018 and January 2020. All participants provided written informed consent. The criteria for inclusion in our experiment are as follows: over 18 years old; with the history of at least 6 months of lateral epicondylitis; and the palpation of lateral epicondyle tenderness; visual analog scale (≥4). In the group A, the patient were injected the autologous blood. In group B, the patients were immersed with 0.5% of bupivacaine (1 ml) and local corticosteroids (2 ml) at lateral epicondyle. The outcomes were composed of a visual analog scores of subjective pain severity over the past 24 hours as the primary result; and limb function in various tasks of daily activity measured with disabilities of the arm, shoulder, and hand quick questionnaire scores, the maximum grip strength and the modified scores of Nirschl, as secondary results. All the results were assessed before the injection and at 4 weeks and 8 weeks after the injection. For all examination, when the P value was less than .05, it would be defined to be a statistically significant difference. RESULTS: The results of this study would provide new information about the influence of autologous blood injections in treating the lateral epicondylitis. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry6263).