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NCT Number: NCT07513350

Investigation of the Effectiveness of Exercise and Anti-Fibrotic Approaches in Frozen Shoulder

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)

    Time frame: At baseline, at week 4, and at week 8

    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.

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: At baseline, at week 4, and at week 8

    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."

  2. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

    Time frame: At baseline, at week 4, and at week 8

    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.

  3. Pain Catastrophizing Scale (PCS)

    Time frame: At baseline, at week 4, and at week 8

    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.

  4. Shoulder Range of Motion

    Time frame: At baseline, at week 4, and at week 8

    Shoulder range of motion will be measured in degrees using a universal goniometer. Measurements will include flexion, abduction, external rotation, and internal rotation.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Betül Erol, Bachelor's degree

CONTACT

[email protected]

+90 534 669 14 06

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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