Exercise plus losartan for frozen shoulder
Investigation of the Effectiveness of Exercise and Anti-Fibrotic Approaches in Frozen Shoulder
This trial will test whether adding a daily low dose of losartan to a four-week physiotherapy program helps adults with frozen shoulder have less pain and better shoulder motion and function than physiotherapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07513350 on ClinicalTrials.gov |
What this trial studies
This randomized trial will enroll 33 adults with adhesive capsulitis and assign them to either a physiotherapy-only group or a physiotherapy plus losartan group. All participants receive the same supervised physiotherapy program twice weekly for four weeks, home exercises, patient education, and cold application; the losartan group also takes 12.5 mg orally once daily for four weeks. Outcomes including Q-DASH and ASES function scores, numeric pain ratings at rest/activity/night, shoulder range of motion measured by goniometer, and pain catastrophizing are measured at baseline and at weeks 4 and 8. Participants are followed for eight weeks total to compare changes between groups.
Who should consider this trial
Good fit: Adults (age 18+) with stage II or III adhesive capsulitis who have documented ≥25% loss of shoulder range of motion in at least two planes (or <50% ROM in one plane) compared with the unaffected side are ideal candidates.
Not a fit: Patients with stage I disease, rotator cuff pathology or glenohumeral arthritis, prior shoulder surgery, inflammatory joint disease, hypotension, pregnancy/breastfeeding, or other contraindications to angiotensin receptor blockers are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding losartan could speed recovery by reducing shoulder pain and improving range of motion and daily function more than physiotherapy alone.
How similar studies have performed: The antifibrotic use of ARBs like losartan is supported by preclinical data and limited clinical work in fibrotic conditions, but randomized trials specifically for frozen shoulder are sparse, so this approach is relatively novel in this condition.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Istanbul
- Istanbul University-Cerrahpasa — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ayşe Betül Erol, Bachelor's degree
- Email: aysebetul.yildiz@ogr.iuc.edu.tr
- Phone: +90 534 669 14 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.