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RecruitingNCT07513350Updated Apr 7, 2026

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

An interventional study of Patient Education and Shoulder Exercise Therapy in Adhesive Capsulitis of Shoulder, sponsored by Istanbul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
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).

02

Conditions studied

  • Adhesive Capsulitis of Shoulder

Keywords

  • Frozen shoulder
  • Exercise therapy
  • Losartan
  • Shoulder pain
03

In context

Bursitis

383 studies on the registry are indexed under Bursitis; 111 are open to participants now.

This study's planned enrollment of 33 is below the median of 44 across 346 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Istanbul University is the lead sponsor of 511 studies on the registry; 78 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
33 participants (estimated)

Study arms

  • Active comparator
    Physiotherapy Group (FT)

    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.

    Other: Patient Education · Other: Shoulder Exercise Therapy · Other: Joint Mobilization Techniques · Other: Cold Application

  • Experimental
    Physiotherapy + Losartan Group (FT+L)

    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.

    Other: Patient Education · Other: Shoulder Exercise Therapy · Drug: Losartan · Other: Joint Mobilization Techniques · Other: Cold Application

Interventions

  • OtherPatient Education

    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.

  • OtherShoulder Exercise Therapy

    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.

  • OtherJoint Mobilization Techniques

    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.

  • OtherCold Application

    A cold pack will be applied for 15 minutes after each exercise session.

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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."

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Nov 2026, 10 months after the start.

Of 217 non-industry interventional studies with no phase under Bursitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 10 months is close to that.

Counting every sponsor, half of 217 studies reached it within 10 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2026
First posted
Apr 7, 2026
StartActual
Jan 7, 2026
Primary completionEst.
Nov 2026
CompletionEst.
Jan 2027
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07513350
Responsible party
Derya Celik (Professor, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Apr 7, 2026
Start date
Jan 7, 2026
Primary completion
Nov 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Apr 7, 2026

Study contacts

Ayşe Betül Erol, Bachelor's degree
Contact
aysebetul.yildiz@ogr.iuc.edu.tr
+90 534 669 14 06

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Losartan

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