Investigation of the Effectiveness of Exercise and Anti-Fibrotic Approaches in Frozen Shoulder
Istanbul University
33 participants
Jan 7, 2026
INTERVENTIONAL
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
Inclusion Criteria4
- 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 Criteria10
- 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 with allergy to losartan or its active/inactive components
- Patients taking medications known to have adverse interactions with losartan
- Patients who, in the investigator's opinion, have any medical condition, laboratory abnormality, or history that could pose risk, contraindicate participation, affect the conduct, objectives, or evaluation of the study, or prevent full participation in the study
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Interventions
During the first session, participants will receive information about the stages and prognosis of frozen shoulder and recommended sleeping positions for patients who have difficulty sleeping at night due to pain.
Participants in both groups will be enrolled in a structured exercise program consisting of exercises recommended in the literature. This program includes range of motion, stretching, and strengthening exercises. The exercises will be performed under the supervision of a physiotherapist, twice a week for four weeks, totaling eight sessions.
Participants will receive 12.5 mg of oral losartan once daily for four weeks.
Glenohumeral joint distraction and anterior, posterior, and inferior glides will be applied. Each technique will be performed for 2 minutes, with 3 repetitions. The intensity of the mobilization techniques will be adjusted according to each patient's pain and tolerance levels.
A cold pack will be applied for 15 minutes after each exercise session.
Locations(1)
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NCT07513350