Efficacy of needling with or without addition of platelet-rich plasma in cases of refractory epicondylitis to optimal rehabilitative treatment: randomized trial.

Switzerland (ICTRP)

ID di studio ICTRP
NCT03987256 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Tennis Elbow, Randomized Study: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation (BASEC)

Titolo accademico
Tennis Elbow, Randomized Study: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation (ICTRP)

Titolo pubblico
ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation (ICTRP)

Malattie studiate
Tennis Elbow;PRP;Tendinopathy;Tendinosis;Extracorporal Shockwave Therapy (ESWT);Tendon Needling (Peppering);Extensor Carpi Radialis Brevis (ECRB) (ICTRP)

Intervento studiato
Other: Initial rehabilitation protocol;Procedure: Needling with PRP;Procedure: Needling with saline solution (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione

Inclusion Criteria:

- Lesion of the ECRB tendon on ultrasonography ([hypoechogenic area during rest OR
hypoechogenic area during active contraction, OR compressibility of the tendon OR
doppler signal] AND [positive sonopalpation])

- Failure to rehabilitation program including shockwave therapy defined as the need for
the patient undergoing 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: 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 criteria

- Clinical presence of cervicobrachialgia, or pain irradiating into the hand

- Corticosteroids: oral intake or infiltration on the last 3 months

- Proximal radius fracture history

- Active inflammatory rheumatic disorders

- Diabetes mellitus

- Immunocompromized status

- Allergy to local anesthetics

- Bleeding disorders or current anticoagulation therapy

- Other clinically significant concomitant disease states (e.g., renal failure, hepatic
dysfunction, cardiopulmonary significant insufficiency, etc.)

- Known or suspected non-compliance, drug or alcohol abuse

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. 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
(ICTRP)

non disponibile

Endpoint primari e secondari
Pain during isometric contraction of the ECRB (ICTRP)

Ultrasonography of the epicondylar tendon: Sonopalpation;Ultrasonographic aspect of the epicondylar tendon: Compressibility;Ultrasonographic aspect of the epicondylar tendon: Thickness;Ultrasonographic aspect of the epicondylar tendon: Solution of continuity;Ultrasonographic aspect of the epicondylar tendon: Doppler;Ultrasonographic aspect of the epicondylar tendon: Hypoechogenic lesion;Volume of PRP (or saline solution) injected;Volume of PRP prepared;Proportion of patient cured with reeducation protocol;Strength on Jamar test (hand grip strength);PRTEE score (Patient-Rated Tennis Elbow Evaluation);SANE score (Single Assessment Numeric Evaluation);Overall pain evaluation (mean of the 3 last days);Pain during isometric contraction of the ECRB (ICTRP)

Data di registrazione
13.06.2019 (ICTRP)

Inclusione del primo partecipante
01.01.2020 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Adrien Schwitzguébel, MD;Adrien Schwitzguébel, MD;Adrien Schwitzguébel, MD, adrien.schwitzguebel@gmail.com, +4179 762 05 62;+4179 762 05 62, Hôpital de La Providence, (ICTRP)

ID secondari
ECRB_Conservative (ICTRP)

Risultati-Dati individuali dei partecipanti
No (ICTRP)

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT03987256 (ICTRP)