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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01984203
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 65 years of age
* history of shoulder complaints lasting at least 3 months prior to enrolment
* Pain located in the proximal lateral aspect of the upper arm (C5 dermatome) aggravated by abduction
* Positive "Full Can test" AND/OR "Jobes test/Empty Can test" AND/OR "Resisted External Rotation test"
* Positive "Hawkins-Kennedy test AND/OR Neers test
* Ultra-sonographic verification of tendon swelling, hypo echoic areas, fibrillar disruption or neovascularization in the RC.
Exclusion Criteria:
* Resting pain more than 40 mm on a visual analogue scale (VAS);
* Bilateral shoulder pain
* Less than 90 degrees of active elevation of the arm;
* Full thickness RC rupture verified by ultra-sonography;
* Corticosteroid injection within the last 6 weeks;
* Radiologic verified fracture, calcification larger then 5 mm (vertical distance) in the RC tendon, glenohumeral arthrosis or malalignment in the shoulder complex;
* Prior surgery or dislocation of the affected shoulder;
* Clinically suspected labrum lesion, arthritis in the AC-joint, frozen shoulder or symptoms derived from the cervical spine;
* Sensory or motor deficit in neck or arm;
* Suspected competing diagnoses (e.g., Rheumatoid arthritis, Cancer, Neurological disorders, Fibromyalgia, Schizophrenia, Suicidal threatened, Borderline personality disorder, or Obsessive Compulsive Disorder);
* Pregnancy;
* Inability to fluently understand written and spoken Danish.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01984203
Study Brief:
Protocol Section:
NCT01984203