Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT03987256
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03987256
Study Brief:
Protocol Section:
NCT03987256