epicondylitis MedDRA version: 16.0 Level: LLT Classification code 10024032 Term: Lateral epicondylitis System Organ Class: 100000004863
Conditions
Interventions
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
Sponsors
Jose Ignacio Martin Gomez
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Body Mass Index> 35 ? systemic autoimmune rheumatic disease (connective tissue diseases and vasculitis systemic necrotizing). ? Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%) ? Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9). ? Be undergoing with immunosuppressive therapy and / or warfarin. treatment by corticosteroids during the 3 months prior to inclusion in the study. ? Treatment with NSAIDs, oral corticosteroids within 15 days prior to inclusion in the study ? Severe heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess whether the treatement with PRP improves chronic epicondylitis recalcitrant against lidocaine wet tenotomy, meassured by DASH scale and decreasing pain.;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;Primary end point(s): The percenteage of patients that improve de scale "Form Disabilities of the Arm Shoulder and Harm", (DASH).;Timepoint(s) of evaluation of this end point: Basal, 6th week, 3,6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactIsabel Andi Ortiz
Basque Health Service
Outcome results
None listed