Evaluation of Clinical Efficacy and Comparison of Autologous Platelet Rich Plasma, Hyaluronic Acid, Corticosteroid and Saline Injections for Treating Lateral and Medial Humeral Epicondylopathy

The study will be a single-center, prospective, randomized, double-blinded, controlled trial with placebo. It is planned to enroll 120 patients with lateral epicondylopathy and divide them to four equal groups receiving an autologous platelet rich plasma (PRP) (N1=30), corticosteroid (N2=30) or hyaluronic acid (N3=30) injection in the area of lateral epicondyle, or to control group (N4=30) receiving an injection of saline in the same area.

After meeting the inclusion and exclusion criteria and before therapeutic intervention patients will undergo clinical and radiological examination and laboratory analysis of blood samples - complete blood count, C reactive protein (CRP), selected cytokines. Elbow anterior-posterior and lateral view X-ray and ultrasound examination will be performed to find signs of enthesopathy, asses calcifications and to exclude other pathologies.

To measure the clinical effectiveness of the treatment examination including range of motion, limb girth measurements, grip and muscle strength measured by dedicated device (digital dynamometer) and regional pain severity measured by professional digital algometer will be performed. Patients will be asked to fulfil pain, functional and quality of live questionnaires, including Visual Analog Scale for pain intensity evaluation (VAS), Patient-rated Tennis Elbow Evaluation (PRTEE), Disabilities of the Arm, Shoulder, and Hand (DASH), The Mayo Elbow Performance Score (MEPS), The Oxford Elbow Score, The Subjective Elbow Value (SEV) and The Quality of life questionnaire SF-36.

Patients from the experimental group will receive an injection of autologous platelet-rich plasma (PRP) without activator (2ml) in the area of attachment of the common extensor tendon under supervision of ultrasound (N1=30), corticosteroid - 2ml of 7mg Betamethasone (N2=30) or 2ml of 40mg hyaluronic acid with mannitol (N3=30). Patients from control group will get an injection of saline (2ml 0,9% NaCl) in the same area (N=30). The injection will be carried out with aseptic precautions, under regional anesthesia with Lignocaine 1%. Saline injection as placebo intervention for control group was chosen because of a similar impression for the patient comparing to other injections. Also there are some previously reported positive outcomes of that kind of intervention alone. The procedure will be performed in accordance with the principle of double-blinding. Every patient will get identification number which will be randomly assigned to one from all groups, in equal proportion. Both, patient and investigator will not know what kind of substance was used for the treatment. Only person giving the injection will have access to patients identification numbers list and will know the exact type of treatment.

Part of the PRP sample (1ml) will undergo laboratory analysis of levels of bioactive compounds. Assessment of levels and concentrations of platelets, white blood cells and erythrocytes will be performed. The investigators will evaluate the content of selected cytokines in PRP using flow cytometry for growth hormones: Platelet Derived Growth Factor-AA (PDGF-AA), Platelet Derived Growth Factor-BB (PDGF-BB), Vascular Endothelial Growth Factor (VEGF), Epidermal Growth Factor (EGF), Hepatocyte Growth Factor (HGF), Fibroblast Growth Factor basic (FGF), Transforming Growth Factor Beta1 free active (TGFβ1) and inflammatory cytokines: Interleukin-1β (IL-1β), Interferon-α2 (IFN-α2), Interferon-γ (IFN-γ), Tumor Necrosis Factor -α (TNF-α), Monocyte Chemotactic Protein -1 (MCP-1), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Interleukin-12p70 (IL-12p70), Interleukin-17A (IL-17A), Interleukin-18 (IL-18), Interleukin-23 (IL-23), Interleukin-33 (IL-33).