Study to prove the safety and efficacy of platelet rich plasma tenotomy for the treatment of chronic epicondylitis

Active, not recruiting

• Conditions: epicondylitis; MedDRA version: 16.0Level: LLTClassification code 10024032Term: Lateral epicondylitisSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-000478-32-ES
• Lead Sponsor: Jose Ignacio Martin Gomez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified