Eligibility Module

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 @ 10:29 PM
Ignite Modification Date: 2025-12-24 @ 10:29 PM
NCT ID: NCT04687735
Eligibility Criteria: Inclusion Criteria: * Age ≥18 years * Diagnosis of unilateral or bilateral frozen shoulder, defined as greater than 50% limitation of passive ROM relative to the non affected side in one or more of three movement directions (i.e., abduction in the frontal plane, forward flexion in the sagittal plane, or external rotation in 0° of abduction) with a hard end feel * Symptoms of frozen shoulder that had lasted for at least 3 months. * Willing and able to provide informed consent and perform home-based exercises as instructed. * Willing and able to complete study questionnaires Exclusion Criteria: * Previous manipulation of the affected shoulder under anesthesia in the last year; * Other rheumatic conditions involving the shoulder (e.g., rheumatoid arthritis, ankylosing Spondylitis, * Fracture or dislocation of the affected shoulder; * Previous shoulder surgery; * Hill-Sachs lesion, severe osteoporosis, or malignancies in the shoulder region); * Neurologic deficits affecting shoulder function; * History of allergy to lidocaine; * Corticosteroid injection in the affected shoulder during the receding 4 weeks. * Non-English speakers; * Active non- controlled mental disorders * Multiple complete tear in ligaments of rotator cuff * Any infection including COVID-19
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT04687735
Study Brief:
Protocol Section: NCT04687735