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 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT02304003
Eligibility Criteria:
Inclusion Criteria:
Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )
1. Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
2. Symptom duration of minimum 3 months.
3. Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:
* Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop \& Veer, 2003)
* Painful arc during active abduction (Ombregt, Bisschop \& Veer, 2003)
* Positive Neers sign (Neer, 1972 ; Tennent, Beach \& Meyers, 2003)
* Positive Jobes test (Jobe \& Moynes, 1982 ; Tennent, Beach \& Meyers, 2003)
* Positive Hawkins-Kennedy impingement test (Hawkins \& Kennedy, 1980)
Exclusion Criteria:
1. Shoulder pain due to trauma, e.g. fall.
2. Reduced ROM consistent with adhesive capsulitis/frozen shoulder
3. History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
4. Full thickness rupture of rotator cuff tendon
5. OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
6. Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
7. Subjects suffering from serious psychiatric illness.
8. Subjects unable to understand English or Norwegian.
9. Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02304003
Study Brief:
Protocol Section:
NCT02304003