Adhesive Capsulitis of ShoulderNCT07513350
Investigation of the Effectiveness of Exercise and Anti-Fibrotic Approaches in Frozen Shoulder
A study testing Patient Education, Shoulder Exercise Therapy and Losartan in people with Adhesive Capsulitis of Shoulder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Patient Education, Shoulder Exercise Therapy and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul
About this study
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.
Read the detailed description
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).
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Patient Education, Shoulder Exercise Therapy, Losartan, Joint Mobilization Techniques, Cold Application
- Keywords
- Frozen shoulder, Exercise therapy, Losartan, Shoulder pain
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
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 TherapyOther
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.
LosartanDrug
Participants will receive 12.5 mg of oral losartan once daily for four weeks.
Joint Mobilization TechniquesOther
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 ApplicationOther
A cold pack will be applied for 15 minutes after each exercise session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient Education; Other: Shoulder Exercise Therapy; Other: Joint Mobilization Techniques; Other: Cold Application |
| 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. Receives: Other: Patient Education; Other: Shoulder Exercise Therapy; Drug: Losartan; Other: Joint Mobilization Techniques; Other: Cold Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, at week 4, and at week 8
Secondary outcomes (4)
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."
Measured: At baseline, at week 4, and at week 8
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
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.
Measured: 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.
Measured: 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.
Measured: At baseline, at week 4, and at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start7 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Celik, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513350
- Sponsor's protocol ID
- 4801230564
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Exercise and Anti-Fibrotic Approaches in Frozen Shoulder
- ClinicalTrials.gov ID
- NCT07513350
- Acronym / sponsor ID
- 4801230564
- Conditions
- Adhesive Capsulitis of Shoulder
- Keywords
- Frozen shoulder, Exercise therapy, Losartan, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy Group (FT) | Active comparator | Other: Patient Education, Other: Shoulder Exercise Therapy, Other: Joint Mobilization Techniques, Other: Cold ApplicationParticipants 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. |
| Physiotherapy + Losartan Group (FT+L) | Experimental | Other: Patient Education, Other: Shoulder Exercise Therapy, Drug: Losartan, Other: Joint Mobilization Techniques, Other: Cold ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient EducationDuring 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. | Other | Physiotherapy + Losartan Group (FT+L), Physiotherapy Group (FT) |
| Shoulder Exercise TherapyParticipants 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. | Other | Physiotherapy + Losartan Group (FT+L), Physiotherapy Group (FT) |
| LosartanParticipants will receive 12.5 mg of oral losartan once daily for four weeks. | Drug | Physiotherapy + Losartan Group (FT+L) |
| Joint Mobilization TechniquesGlenohumeral 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. | Other | Physiotherapy + Losartan Group (FT+L), Physiotherapy Group (FT) |
| Cold ApplicationA cold pack will be applied for 15 minutes after each exercise session. | Other | Physiotherapy + Losartan Group (FT+L), Physiotherapy Group (FT) |
Primary outcome
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.
4 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: At baseline, at week 4, and at week 8
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: At baseline, at week 4, and at week 8
Pain Catastrophizing Scale (PCS)
Time frame: At baseline, at week 4, and at week 8
Shoulder Range of Motion
Time frame: At baseline, at week 4, and at week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education, Shoulder Exercise Therapy and Losartan in people with Adhesive Capsulitis of Shoulder, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Betül Erol, Bachelor's degree (+90 534 669 14 06, aysebetul.yildiz@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) (time frame: At baseline, at week 4, and at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.