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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT04073212
Eligibility Criteria:
Inclusion Criteria:
* Age 18-64 years old
* Primary diagnosis of bicipital tendinopathy
* Primary complaint of anterior shoulder pain in the area of the LHBT
* Clinical exam findings (must have positive findings for at least 1/2 of the following: Speed's Test, Yergason's test for biceps tendon pain.
* Pain with palpation in area of the biceps tendon
* Patient identification of pain in the area of the proximal biceps tendon
* NPRS of at least 3/10 at worst in the past week
Exclusion Criteria:
* History of biceps tendon injection in the past 3 months
* History of rotator cuff surgery
* History of biceps tenodesis or tenotomy
* History of bleeding disorder or anti-coagulation therapy
* Diagnosis of adhesive capsulitis (as defined by 50% loss of range of motion in 2 out of 3 of the following motions: Shoulder flexion, abduction and external rotation)
* Known underlying non-modifiable medical condition (e.g. tumor, fracture, metabolic disease)
* Two or more positive neurological signs consistent with nerve root compression
* Known allergy to metal
* Participant reported aversion to needles
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04073212
Study Brief:
Protocol Section:
NCT04073212