Informations générales
  • Catégorie de maladie Maladies ostéomusculaires (BASEC)
  • Study Phase N/A (ICTRP)
  • État du recrutement recrutement en cours (BASEC/ICTRP)
  • Lieu de l’étude
    Neuchâtel
    (BASEC)
  • Responsable de l'étude Dr Adrien Schwitzguébel secretariat.schwitzguebel@providence.ch (BASEC)
  • Source(s) de données BASEC: Importé de 24.07.2025 ICTRP: Importé de 19.04.2023
  • Date de mise à jour 24.07.2025 11:16
HumRes46384 | SNCTP000003504 | BASEC2019-01621 | NCT03987256

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

  • Catégorie de maladie Maladies ostéomusculaires (BASEC)
  • Study Phase N/A (ICTRP)
  • État du recrutement recrutement en cours (BASEC/ICTRP)
  • Lieu de l’étude
    Neuchâtel
    (BASEC)
  • Responsable de l'étude Dr Adrien Schwitzguébel secretariat.schwitzguebel@providence.ch (BASEC)
  • Source(s) de données BASEC: Importé de 24.07.2025 ICTRP: Importé de 19.04.2023
  • Date de mise à jour 24.07.2025 11:16

Résumé de l'étude

This study focuses on patients suffering from epicondylitis. Firstly, all patients will undergo a rehabilitation phase lasting 3 months, during which they will benefit from the following therapies: - Manual therapies - Supervised strengthening and stretching exercise program - Taping or wearing a small support brace - Focused shockwave therapy If the outcome is not satisfactory after 3 months, they will undergo needle screening of the epicondylar tendon. At the end of the procedure, an injection containing either PRP or saline solution will be performed. The nature of the injection will be determined randomly. We will be interested in the clinical outcomes of these treatments, but also in the ultrasound aspect of the tendon before and after the procedure. We plan to include a total of 232 patients, and we expect that 58 patients will require tendon screening. Patients will be followed for 15 months.

(BASEC)

Intervention étudiée

The aim of needle screening of the epicondylar tendons is twofold:

- To stimulate biology to promote tendon regeneration

- To lengthen the tendon to limit the mechanical overload it suffers daily

 

An injection of one's own platelet-rich plasma immediately after the screening could optimize biological stimulation and thus optimize tendon regeneration. However, to date, current studies do not allow us to say whether this injection is of any use.

(BASEC)

Maladie en cours d'investigation

Epicondylitis

(BASEC)

Critères de participation
Epicondylitis with involvement of the short radial extensor tendon of the wrist Age 18-65 years (BASEC)

Critères d'exclusion
Presence of another diagnosis that could potentially explain the symptoms (neuralgia, bone involvement, ...) Presence of a condition that could block the effectiveness of platelet-rich plasma (cortisone use, diabetes, immunosuppression) (BASEC)

Lieu de l’étude

Neuchâtel

(BASEC)

Switzerland (ICTRP)

Sponsor

Not applicable

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Dr Adrien Schwitzguébel

+41 32 720 32 75

secretariat.schwitzguebel@providence.ch

AS médecine du sport

(BASEC)

Informations générales

Hôpital de La Providence,

+4179 762 05 62;+4179 762 05 62

secretariat.schwitzguebel@providence.ch

(ICTRP)

Informations scientifiques

Hôpital de La Providence,

+4179 762 05 62;+4179 762 05 62

secretariat.schwitzguebel@providence.ch

(ICTRP)

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique du Vaud

(BASEC)

Date d'approbation du comité d'éthique

24.10.2019

(BASEC)


Identifiant de l'essai ICTRP
NCT03987256 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Tennis Elbow, Randomized Study: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation (BASEC)

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

Titre public
ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation (ICTRP)

Maladie en cours d'investigation
Tennis Elbow;PRP;Tendinopathy;Tendinosis;Extracorporal Shockwave Therapy (ESWT);Tendon Needling (Peppering);Extensor Carpi Radialis Brevis (ECRB) (ICTRP)

Intervention étudiée
Other: Initial rehabilitation protocol;Procedure: Needling with PRP;Procedure: Needling with saline solution (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Critères d'inclusion/exclusion

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 disponible

Critères d'évaluation principaux et secondaires
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)

Date d'enregistrement
13.06.2019 (ICTRP)

Inclusion du premier participant
01.01.2020 (ICTRP)

Sponsors secondaires
non disponible

Contacts supplémentaires
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 secondaires
ECRB_Conservative (ICTRP)

Résultats-Données individuelles des participants
No (ICTRP)

Informations complémentaires sur l'essai
https://clinicaltrials.gov/show/NCT03987256 (ICTRP)

Résultats de l'essai

Résumé des résultats

non disponible

Lien vers les résultats dans le registre primaire

non disponible