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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:
A total of 33 patients diagnosed with frozen shoulder at the Orthopedics and Traumatology Clinic of Istanbul Faculty of Medicine will be included in this study. Patients will be randomly assigned to two groups using a computer-based randomization method: the physiotherapy-only group (FT) and the physiotherapy plus losartan group (FT+L). The same physiotherapy program will be applied to all patients. Both groups will receive a treatment program including range of motion exercises, stretching, strengthening exercises, and mobilization techniques. All participants will receive patient education and a home exercise program during the first session. After the exercises, a 15-minute cold application will be applied both at home and in the clinic. Patients will receive physiotherapy sessions twice a week for four weeks and will be followed for a total of eight weeks. In addition, patients in the FT+L group will receive 12.5 mg of oral losartan once daily for four weeks. All patients will be evaluated before treatment and at the 4th and 8th weeks after treatment initiation. Functional status will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (Q-DASH) and the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES). Pain at rest, during activity, and at night will be evaluated using the Numeric Pain Rating Scale (NPRS). Shoulder range of motion will be measured using a universal goniometer, and pain catastrophizing levels will be assessed using the Pain Catastrophizing Scale (PCS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy Group (FT) | Active Comparator | Participants will receive a physiotherapy program including range of motion exercises, stretching, strengthening exercises, and mobilization techniques. The program will be conducted twice a week for four weeks, totaling eight sessions. During the first session, participants will receive patient education and a home exercise program. After each exercise session, a 15-minute cold application will be applied. |
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| Physiotherapy + Losartan Group (FT+L) | Experimental | Participants will receive the same physiotherapy program as the FT group. In addition, participants in this group will receive 12.5 mg of oral losartan once daily for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) | The Q-DASH is a questionnaire used to assess upper extremity function and symptoms. It consists of 11 items, each scored from 1 to 5. The total score ranges from 0 to 100, with higher scores indicating greater functional limitation. | At baseline, at week 4, and at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Patients' pain at rest, during activity, and at night will be assessed using the NPRS. The NPRS is scored from 0 to 10, with 0 indicating "no pain" and 10 indicating "worst imaginable pain." | At baseline, at week 4, and at week 8 |
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayşe Betül Erol, Bachelor's degree | Contact | +90 534 669 14 06 | aysebetul.yildiz@ogr.iuc.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Recruiting | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D018771 | Arthralgia |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Shoulder Exercise Therapy | Other | 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. |
|
| Losartan | Drug | Participants will receive 12.5 mg of oral losartan once daily for four weeks. |
|
| Joint Mobilization Techniques | Other | 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. |
|
| Cold Application | Other | A cold pack will be applied for 15 minutes after each exercise session. |
|
The ASES is a questionnaire used to assess patients' shoulder function and pain levels. The scale consists of 10 items. The total score ranges from 0 to 100, with higher scores indicating better functional ability. |
| At baseline, at week 4, and at week 8 |
| Pain Catastrophizing Scale (PCS) | Pain Catastrophizing Scale (PCS) is used to assess individuals' levels of pain catastrophizing. The scale consists of 13 items, each scored from 1 to 4. Total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. | At baseline, at week 4, and at week 8 |
| Shoulder Range of Motion | Shoulder range of motion will be measured in degrees using a universal goniometer. Measurements will include flexion, abduction, external rotation, and internal rotation. | At baseline, at week 4, and at week 8 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |