Pilot randomised trial to assess the safety and potential efficacy of platelet rich plasma tenotomy for the treatment of chronic epicondylitis

INTERVENTION: Product Name: liquid PRP Product Code: PRPtendon Pharmaceutical Form: Injection INN or Proposed INN: PRP autologo CAS Number: No aplica Current Sponsor code: B‐PRPtendon Other descriptive name: HUMAN PLASMA PROTEIN Concentration unit: ml millilitre(s) Concentration type: up to Concentration number: 5‐ CONDITION: epicondylitis ; MedDRA version: 16.0 Level: LLT Classification code 10024032 Term: Lateral epicondylitis System Organ Class: 100000004863 Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: Assess whether the treatement with PRP improves chronic epicondylitis recalcitrant against lidocaine wet tenotomy, meassured by DASH scale and decreasing pain. Primary end point(s): The percenteage of patients that improve de scale "Form Disabilities of the Arm Shoulder and Harm", (DASH). Secondary Objective: To evaluate the clinical efficacy and safety of PRP in chronic epicondylitis; 2. Assess structural changes (by ultrasound) in the tendon secondary to treatment with PRP; 3. Assess whether the application of this technology is feasible ; 4. Assess the feasibility of the protocol Timepoint(s) of evaluation of this end point: Basal, 6th week, 3,6 and 12 months SECONDARY OUTCOME: Secondary end point(s): Variables evolution; On the first visit they passed the visual analogue scale (VAS) to assess pain: You are asked by the; maximum pain caused by epicondylitis and punctuate it on the scale.; VERY IMPORTANT: The patient is 48 hours without taking any pain medication before; EVA complete scales and initial DASH.; Variables relating to the application of treatment; Time of blood collection; Treatment given (A or B); Intervention location; Duration of intervention (start and end); Optional charge; Adverse events related to the arm Timepoint(s) of evaluation of this end point: Basal, 6th week, 3,6 and 12 months INCLUSION CRITERIA: Patients of both sexes aged 35 to 75 years. Pain in the arm 3 or more points in VAS. Values ??of BMI between 20 and 35. Possibility for observation during the follow up period. Epicondylitis diagnosed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range