NTR5005.

Study name	Effect of a platelet rich plasma (PRP) injection on the outcome of chronic lateral epicondylitis: a double blinded randomised controlled clinical trial
Methods	2‐arm parallel randomised controlled trial
Participants	Inclusion criteria Elbow epicondylar pain increasing with pressure and with resisted wrist extension or with resisted third finger extension Duration > 6 months Resistance to conservative treatment programme PRTEE score ≥ 40 Aged 18 to 70 years Abnormal findings on ultrasound, suspicious for lateral epicondylitis (abnormal findings are abnormal echogenicity, calcifications, thickened origin of the extensor tendon, irregular erosive cortex of the lateral epicondyle, neovascularisation, and rupture) Exclusion criteria Previous local injection therapy in the past 6 months Use of NSAIDs Pregnancy Other disease with potential influence on tendinopathy or PRP treatment effect, such as inflammatory arthritis, autoimmune disease, CRPS, fibromyalgia, or signs of posterior interosseous nerve entrapment.
Interventions	Platelet‐rich plasma (PRP) 3‐mL injection Saline 3‐mL injection
Outcomes	Outcomes are measured at 6 months Primary outcome Patient Rated Tennis Elbow Evaluation (PRTEE) questionnaire Secondary outcomes VAS score Ultrasound at 6 months DASH score (including work and sports/performing arts module) Pain‐free grip strength and maximum grip strength measured with a dynamometer 3 global change indices (GCI), which consist of the quality of the most commonly performed activity (e.g. hammering, writing), satisfaction of the individual with treatment received, and extent of compliance with home‐based exercise
Starting date	01/01/2015
Contact information	Reinoud Meijer; MeijerR@zgv.nl; The Netherlands
Notes	Recruitment pending

ASES: American Shoulder and Elbow Surgeons score.

BMI: body mass index.

CLE: chronic lateral epicondylosis.

DASH: Disabilities of the Arm, Shoulder and Hand questionnaire.

ECRB: extensor carpi radialis brevis tendon.

EQ‐5D: EuroQoL Group Quality of Life Questionnaire based on 5 dimensions

EVA: Electronic visual analog

LE: lateral epicondylitis.

NSAID: non‐steroidal anti‐inflammatory drug.

PRP: platelet‐rich plasma.

PrT‐D: Prolotherapy Dextrose

PrT‐DMS: Prolotherapy Dextrose and Morrhuate sodium

TC: Total count

VAS: visual analogue scale.