Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
Tennis Elbow
About this trial
This is an interventional treatment trial for Tennis Elbow focused on measuring Platelet rich plasma, Leukocyte-rich PRP, Leukocyte-poor PRP, PRP, PRP injection, Double-blind randomized controlled clinical trial
Eligibility Criteria
Inclusion Criteria: Patients with epicondylitis of the elbow: Patients with clinical picture of epicondylitis; Duration of symptoms > 3 months Ultrasound picture of short or long radial extensor carpal tendinopathy; Age > 18 and < 65 Both sexes; Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months; Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC examination); Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab No clinically significant electrocardiographic changes (Recently performed ECG); Ability and consent of the patient to actively participate in clinical follow-up; Signature of informed consent. Exclusion Criteria: Patients undergoing previous surgical treatment on the epicondylar tendons; Patients undergoing epicondylar infiltration in the previous 6 months; Inability of patients to actively participate in clinical follow-up; Incapacitated patients; Patients with states of immunodepression; Patients with fibromyalgia; Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications); Patients with uncontrolled thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or medications; Patients who have taken NSAIDs in the 3 days prior to blood collection; Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw; Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated; Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)
Sites / Locations
- Istituto Ortopedico RizzoliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Leukocyte-rich Platelet rich plasma (LR-PRP)
Leukocyte-poor Platelet rich plasma (LP-PRP)
Saline solution
This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.
This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.
This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list.