NTR4569.

Study name	Standardised needle therapy in LE
Methods	3‐arm parallel randomised controlled trial
Participants	Inclusion criteria • Patients referred by their GP to the orthopaedic surgeon with diagnosed unilateral lateral epicondylitis lasting longer than 6 weeks • Age between 18 and 65 years • Unsuccessful conservative treatment • Able to read and write in Dutch • Provision of informed consent by patient. Exclusion criteria • Prior injection therapy (during this episode of LE), surgery, or trauma at the affected elbow • Inflammatory disease (i.e. rheumatoid arthritis, psoriatic arthritis, or reactive arthritis) • Any other elbow pathology • Neck pain or shoulder pain correlated with elbow pain such as C6 radiculopathy or disability of the arm or other chronic widespread pain syndrome • Traumatic onset of LE • Bilateral LE (mild case of LE on the contralateral elbow without functional limitations allowed) • Abnormality on X‐ray • Additional pain at the medial epicondyle • Allergy to lidocaine
Interventions	All treatments will be performed ultrasound‐guided and in a standardised and automated way Autologous blood injection Perforation with infiltration of 0.4 cc autologous blood; blood is taken by venipuncture and is directly injected into the affected tendon Dextrose injection Perforation with infiltration of 0.4 cc dextrose: solution with 4 mL of 50% dextrose + 4 mL of 90% saline + 2 mL of 1% lidocaine Sham injection Perforation without infiltration
Outcomes	Outcomes are measured at 5 months Primary outcome Pain measured on VAS (0 to 100). After provocation test, pain during resisted dorsiflexion of the wrist during full elbow extension Secondary outcomes Pain on VAS Quality of life Adverse events
Starting date	01/11/2015
Contact information	R. Keijsers; reneekeijsers@gmail.com; The Netherlands
Notes	Recruitment pending