NCT03987256.

Study name	Tennis elbow, randomized study: needling with and without platelet‐rich plasma after failure of up‐to‐date rehabilitation
Methods	Single‐centre 2‐arm parallel randomised controlled trial
Participants	Inclusion criteria Lesion of the ECRB tendon on ultrasonography ([hypo‐echogenic area during rest or hypo‐echogenic area during active contraction, or compressibility of the tendon, or doppler signal] and [positive sonopalpation]) Failure of rehabilitation programme including shock wave therapy defined as the need for patient to undergo additional therapies Exclusion criteria Presence on ultrasound of an isolated lesion of the superficial epicondylar tendons as described above, with intact ECRB Presence on ultrasound of any of the following: radiohumeral synovial material; interruption of the lateral collateral ligament; radial nerve entrapment (i.e. under the arcade of Frohse); osteochondral lesion; joint effusion. Note: calcic enthesophytes are not considered as an exclusion criterion Clinical presence of cervicobrachialgia, or pain radiating into the hand Glucocorticoid: oral intake or infiltration in the last 3 months Proximal radius fracture history Active inflammatory rheumatic disorder Diabetes mellitus Immunocompromized status Allergy to local anaesthetic Bleeding disorder or current anticoagulation therapy Other clinically significant concomitant disease state (e.g. renal failure, hepatic dysfunction, cardiopulmonary significant insufficiency) Known or suspected non‐compliance, drug or alcohol abuse Inability to follow procedures of the study (e.g. due to language problems, psychological disorders, dementia of the participant) Participation in another study with investigational drug within the 30 days preceding and during the present study Previous enrolment into the current study Enrolment of the investigator, his/her family members, employees, and other dependent persons
Interventions	Needling with PRP vs needling with saline solution
Outcomes	Primary outcome measure Pain during isometric contraction of the ECRB [Time Frame: 3 months] Pain is evaluated on a 0 to 10 scale (0 = no pain) during isometric contraction manoeuvre of the ECRB Secondary outcome measures Pain during isometric contraction of the ECRB [Time Frame: ‐3, 0, 6, & 12 months] Pain is evaluated on a 0 to 10 scale (0 = no pain) during isometric contraction manoeuvre of the ECRB Overall pain evaluation (mean of last 3 days) [Time Frame: ‐3, 0, 3, 6, & 12 months] Pain is evaluated on a 0 to 10 scale (0 = no pain) SANE score (Single Assessment Numeric Evaluation) [Time Frame: ‐3, 0, 3, 6, & 12 months] Function is evaluated on a 0 to 100% scale (100 = good function) PRTEE score (Patient‐Rated Tennis Elbow Evaluation) [Time Frame: ‐3, 0, 3, 6, & 12 months] Score going from 0 to 100 (0 = good outcome) Strength on Jamar test (hand grip strength) [Time Frame: ‐3, 0, 3, 6, & 12 months] Grip strength measured in kg (higher strength = better outcome) Proportion of patients cured with re‐education protocol [Time Frame: 0 months] Descriptive statistics: evaluation of the proportion of patients for which tendon needling is not necessary Volume of PRP prepared [Time Frame: 0 months] Descriptive statistics: quantity of PRP prepared (in mL) Volume of PRP (or saline solution) injected [Time Frame: 0 months] Descriptive statistics: quantity of PRP (or saline solution) injected (in mL) Ultrasonographic aspect of the epicondylar tendon: hypo‐echogenic lesion [Time Frame: ‐3, 0, 3, & 6 months] The tri‐dimensional volume of the lesion is measured in mm³ Ultrasonographic aspect of the epicondylar tendon: Doppler [Time Frame: ‐3, 0, 3, & 6 months] The Doppler reaction will be evaluated on a subjective scale (none, mild, average, high, huge) Ultrasonographic aspect of the epicondylar tendon: solution of continuity [Time Frame: ‐3, 0, 3, & 6 months] During active contraction of the ECRB, an eventual solution of continuity will be measured in mm Ultrasonographic aspect of the epicondylar tendon: thickness [Time Frame: ‐3, 0, 3, & 6 months] The thickness of the common epitrochlear will be measured in mm Ultrasonographic aspect of the epicondylar tendon: compressibility [Time Frame: ‐3, 0, 3, & 6 months] The presence or absence of compressibility of the common epitrochlear tendon (binary outcome) Ultrasonography of the epicondylar tendon: sonopalpation [Time Frame: ‐3, 0, 3, & 6 months] Patient pain on sonopalpation will be evaluated on a 0 to 10 scale (0 = no pain)
Starting date	1 January 2020
Contact information	Adrien Schwitzguébel, Hôpital La Providence, Sports Medicine Neuchâtel, Switzerland +4179 762 05 62 adrien.schwitzguebel@gmail.com
Notes	Recruiting