EUCTR201300047832ES.

Trial name or title	Pilot randomised trial to assess the safety and potential efficacy of platelet rich plasma tenotomy for the treatment of chronic epicondylitis
Methods	Study design: randomised trial Random sequence generation: not reported Allocation concealment: not reported Masking: single blind (details not reported)
Participants	Location: not reported Target sample size (N): not reported Inclusion criteria: participants of both sexes aged 35‐75 years; pain in the arm scoring ≥ 3 points on VAS; values of BMI between 20‐35; possibility for observation during the follow‐up period; epicondylitis diagnosed Exclusion criteria: BMI > 35; systemic autoimmune rheumatic disease (connective tissue diseases and vasculitis systemic necrotising); poorly‐controlled diabetes mellitus (glycosylated haemoglobin above 9%); blood disorders (thrombopathy, thrombocytopenia, anaemia with Hb < 9); having immunosuppressive therapy and/or warfarin, or treatment with corticosteroids during the 3 months prior to inclusion in the study; treatment with NSAIDs, or oral corticosteroids within 15 days prior to inclusion in the study; severe heart disease
Interventions	PRP: PRP injection (details were not reported) Controls or placebo or no intervention (standard care): lidocaine wet tenotomy
Outcomes	Primary outcomes: DASH Secondary outcomes: structural changes (by ultrasound) in the tendon secondary to treatment with PRP; assessment of whether the application of this technology is feasible; assessment of the feasibility of the protocol Timing of outcomes measurement: baseline, 6th week, and 3, 6 and 12 months
Starting date	Main ID: EUCTR201300047832ES Date of registration: April 2013 Last refreshed on: August 2013 Date of first enrolment: July 2013 Status: ongoing or finished
Contact information	Name: Isabel Andi Ortiz Address: Plaza de Cruces 48003 Barakaldo, Spain Telephone: 00349460060007005 Email: isabel.andiaortiz@osakidetza.net Affiliation: Basque Health Service
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