NCT07513350 Investigation of the Effectiveness of Exercise and Anti-Fibrotic Approaches in Frozen Shoulder
| NCT ID | NCT07513350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University |
| Condition | Adhesive Capsulitis of Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-01-07 |
| Primary Completion | 2026-11 |
Trial Parameters
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Brief Summary
The purpose of this clinical study is to investigate the efficacy of losartan as an antifibrotic approach in addition to a physiotherapy program in patients diagnosed with frozen shoulder. The effects of losartan use on pain intensity, shoulder joint range of motion, functional status, and pain catastrophizing level will be evaluated and compared with the outcomes of patients participating in a physiotherapy program alone. The key questions this study aims to answer are: * Is there a difference in shoulder functionality between frozen shoulder patients using losartan in addition to a physiotherapy program and those participating in a physiotherapy program alone? * Is there a difference in pain intensity, shoulder joint range of motion, and pain catastrophizing level between frozen shoulder patients using losartan in addition to a physiotherapy program and those participating in a physiotherapy program alone? A total of 33 patients will be enrolled in the study. Participants will be randomly assigned to one of two groups: the physiotherapy group (PT) and the physiotherapy + losartan group (PT+L). Both groups will receive the same physiotherapy program comprising range of motion exercises, stretching exercises, strengthening exercises, and mobilization techniques. Patients in the PT+L group will additionally receive 12.5 mg of oral losartan once daily for four weeks. Clinical assessments will be conducted at baseline, at week 4, and at week 8.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older diagnosed with frozen shoulder (adhesive capsulitis) * Having less than 50% of range of motion (ROM) in at least one of the following shoulder movements compared to the unaffected side: external rotation, abduction, flexion, or internal rotation * Having more than 25% loss of ROM in at least two movement planes compared to the unaffected shoulder * Patients in stage II or III of frozen shoulder Exclusion Criteria: * Women who are pregnant, breastfeeding, or planning pregnancy during the study * Patients in stage I of frozen shoulder * Patients diagnosed with inflammatory or other types of arthritis due to autoimmune diseases affecting the shoulder * Patients with rotator cuff pathology and/or glenohumeral arthritis * Patients with a history of prior shoulder infection * Patients with hypotension * Patients who have undergone previous upper extremity surgery or plan to undergo upper extremity surgery during the study period * Patients