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:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT05384093
Eligibility Criteria:
For Study Group 1- Adhesive Capsulitis (AC)
Inclusion Criteria:
* Exhibits symptoms of adhesive capsulitis i. Shoulder pain with limited motion for more than one month ii. AND ≤ 30 degrees external rotation with arm at side iii. AND ≤ 130 degrees forward flexion d. Cortisone shot for all patients
Exclusion Criteria:
* a. No prior shoulder surgery b. Infection c. Rheumatoid arthritis d. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder
For Study Group 2 - Postoperative Shoulder Stiffness Study (POS)
Inclusion Criteria:
c. Is not recovering normally based on objective criteria set for screening process i. Step 1 - Follow patients -all post-op patients with indicated procedures (see # 7 for list.) ii. Step 2 - Screen Patients -does patient meets inclusion criteria at 6 weeks or 3 months of follow-up?
1. \< 15 degrees external rotation with arm at side at 6 weeks post-op
2. OR \< 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group
Exclusion Criteria:
a. Revision surgery b. Infection c. Rheumatoid arthritis
7\. Procedures included
1. Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
2. ORIF Humerus fracture (23615)
For Study Group 3, Secondary Surgery Study (SAM)
Inclusion Criteria:
3. Underwent a manipulation under anesthesia or a lysis of adhesions procedure
Exclusion Criteria:
a. Infection b. Rheumatoid arthritis c. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder
7\. Procedures included
1. Manipulation under anesthesia (23700)
2. Lysis of adhesions (29825)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05384093
Study Brief:
Protocol Section:
NCT05384093