NCT01668953.

Trial name or title	Impact of platelet rich plasma over alternative therapies in patients with lateral epicondylitis
Methods	Study design: randomised trial Random sequence generation: not reported Allocation concealment: not reported Masking: single blinded
Participants	Location: multicentre Target sample size (N): 60 participants Inclusion criteria: adult men or women aged ≥ 20 years; clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension; documented sonographic diagnosis of common extensor tendinosis and possible tear based on abnormal echo texture (tendon thickening, anechoic areas, areas of hypoechogenicity, loss of fibrillar pattern); chronic symptoms (≥ 3 months); pain of at least 5/10 on a VAS; provision of informed consent Exclusion criteria: acute symptom onset (< 3 months); history of acute elbow trauma, rheumatoid arthritis,malignancy; pregnant or planning on becoming pregnant; requiring antiplatelet medication for the treatment of heart attack, stroke or other medical conditions; previous surgery for lateral epicondylitis; local injections, including steroids within the past 6 months; signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion); problems likely, in the judgment of the investigator, with maintenance of follow‐up; previous randomisation in this study or a competing study
Interventions	PRP: Arthrex ACP system Controls or no intervention (standard care): whole blood injection, dry needle fenestration
Outcomes	Primary outcomes: rate of recruitment; ability to recruit 60 participants within a 12‐month period; adherence to study protocol Secondary outcomes: pain reduction (VAS); functional disability, Liverpool elbow score; psychological impairment (depression and anxiety), HADS; quality of life (SF‐12) Timing of outcomes measurement: 1, 2, 3, 6, 12 months
Starting date	Main ID: NCT01668953 Date of registration: 16 August 2012 Last refreshed on: 26 July 2013 Date of first enrolment: Status: recruiting participants
Contact information	Name: Meg Chiavaras, PhD, MD Address: not reported Telephone: +1 905 5212100 ext 46521 Email: meg.chiavaras@gmail.com Affiliation: McMaster University
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