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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT06916650
Eligibility Criteria:
Inclusion Criteria:
Age between 40 and 70 years, inclusive. Clinical diagnosis of primary (idiopathic) frozen shoulder, defined by shoulder pain and ≥50% restriction in passive external rotation compared to the contralateral (unaffected) shoulder.
Symptom duration between 3 and 9 months. Average shoulder pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) over the past week.
Normal or age-appropriate radiographic findings of the glenohumeral joint (ruling out significant arthritis, fractures, calcific tendinitis).
Willingness and ability to attend scheduled treatment/assessment sessions. Ability to understand study procedures and provide written informed consent.
Exclusion Criteria:
Secondary frozen shoulder (e.g., post-traumatic, post-surgical, related to systemic disease like diabetes - clarify if diabetes is excluded or just secondary FS from diabetes).
Clinical or imaging evidence of significant rotator cuff tear requiring specific management.
Radiographic evidence of moderate to severe glenohumeral osteoarthritis (e.g., Kellgren-Lawrence grade ≥ 3).
Previous surgery on the index shoulder. Significant neurological disorders affecting shoulder or upper extremity function (e.g., cervical radiculopathy, stroke).
Received a corticosteroid injection in the index shoulder within the past 3 months.
Known contraindications to corticosteroid injections (e.g., uncontrolled diabetes, allergy, local infection).
Known contraindications to High-Intensity Laser Therapy (e.g., active malignancy in the treatment area, photosensitivity, pacemaker over treatment area).
Current participation in another interventional clinical trial for shoulder pain.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT06916650
Study Brief:
Protocol Section:
NCT06916650