Supraspinatus TendinopathyNCT07880522
Subacromial Corticosteroid Injection Combined With Exercise in Supraspinatus Tendinopathy
A study testing Subacromial Triamcinolone Acetonide Injection and Home-Based Exercise Program in people with Supraspinatus Tendinopathy, run by Dr.Rumeysa Türkoğlu at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind, placebo-controlled clinical trial evaluates the effects of a subacromial corticosteroid injection combined with a 12-week home-based exercise program in patients aged 18 to 60 years with supraspinatus tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Supraspinatus Tendinopathy
- What is being tested?
- Subacromial Triamcinolone Acetonide Injection and Home-Based Exercise Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 31 Dec 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years.
- Unilateral shoulder pain in the dominant extremity lasting 3 to 12 months.
- At least 3 positive findings among the following clinical tests: painful arc test, Neer test, Hawkins test, Jobe test, and Full Can test.
- Tendinopathy or partial supraspinatus tear (<3 mm; mild/minimal partial tear) confirmed by MRI.
- Patte grade I and Goutallier grade 0-I on MRI.
- Signed informed consent.
Who cannot join
- Full-thickness or advanced partial supraspinatus tear; Patte grade II-III and/or Goutallier grade II-IV.
- Acute trauma or infection.
- History of fracture or shoulder surgery.
- Adhesive capsulitis.
- Significant glenohumeral osteoarthritis.
- Calcific tendinitis.
Show all 14Show fewer
- Systemic rheumatologic disease.
- Malignancy.
- Diabetes mellitus.
- History of shoulder injection within the previous 6 months.
- Coagulopathy.
- Pregnancy.
- Cervical radiculopathy or other neurological deficits in the upper extremity.
- Known neuromuscular disease or brachial plexus injury.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, Istanbul
About this study
Official title: Effect of Subacromial Corticosteroid Injection Combined With an Exercise Program on Tendon Elastography and Clinical Outcomes in Rotator Cuff Pathologies: A Prospective Randomized Controlled Study
This prospective, randomized, double-blind, placebo-controlled clinical trial evaluates the effects of a subacromial corticosteroid injection combined with a 12-week home-based exercise program in patients aged 18 to 60 years with supraspinatus tendinopathy. A total of 56 participants will be randomized into two groups. The intervention group will receive an ultrasound-guided subacromial-subdeltoid injection of 20 mg triamcinolone acetonide plus saline, while the placebo group will receive an ultrasound-guided intramuscular saline injection into the deltoid. Both groups will follow the same 12-week exercise program. The primary outcome is the change in supraspinatus tendon elasticity measured by shear wave elastography. Secondary outcomes include pain, shoulder function, disability, and quality of life assessed using VAS, Constant-Murley Score, QuickDASH, SPADI, and SF-12.
Read the detailed description
Participants who meet the eligibility criteria and provide written informed consent will be randomized using a computer-based block randomization method. The corticosteroid group will receive an ultrasound-guided injection of 20 mg triamcinolone acetonide (1 mL) plus 1 mL saline into the subacromial-subdeltoid bursa. The placebo group will receive an equal volume of 0.9% saline administered intramuscularly into the deltoid under ultrasound guidance.
Following the injection, participants in both groups will begin the same 12-week home-based exercise program, performed three days per week for approximately 30-40 minutes per session. The program includes warm-up, scapular stabilization, rotator cuff strengthening, eccentric exercises, stretching, and mobility exercises, with progression according to pain level, muscle control, and exercise technique.
Shear wave elastography measurements of the supraspinatus tendon will be performed at baseline and at week 12. Clinical assessments, including VAS, SF-12, Constant-Murley Score, QuickDASH, and SPADI, will be performed at baseline, week 6, and week 12. The study aims to determine whether the addition of subacromial corticosteroid injection to exercise alters tendon elasticity and clinical outcomes compared with placebo injection plus exercise.
- Conditions
- Supraspinatus Tendinopathy
- Being tested
- Subacromial Triamcinolone Acetonide Injection, Intramuscular Saline Placebo Injection, Home-Based Exercise Program
- Keywords
- Rotator Cuff, Supraspinatus, Subacromial Corticosteroid Injection, Shear Wave Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subacromial Triamcinolone Acetonide InjectionDrug
A single ultrasound-guided injection of 20 mg triamcinolone acetonide (1 mL) plus 1 mL saline into the subacromial-subdeltoid bursa.
Intramuscular Saline Placebo InjectionDrug
An equal volume of 0.9% saline administered as a single ultrasound-guided intramuscular injection into the deltoid.
Home-Based Exercise ProgramBehavioural
A 12-week home-based exercise program performed 3 days per week for approximately 30-40 minutes per session. The program includes warm-up, scapular stabilization, rotator cuff strengthening, eccentric exercises, stretching, and mobility exercises
| Study group | Role | What they receive |
|---|---|---|
| Subacromial Corticosteroid Injection + Exercise | Experimental | Participants will receive an ultrasound-guided injection of 20 mg triamcinolone acetonide (1 mL) plus 1 mL saline into the subacromial-subdeltoid bursa. Following the injection, participants will begin a 12-week home-based exercise program performed 3 days per week. Receives: Drug: Subacromial Triamcinolone Acetonide Injection; Behavioral: Home-Based Exercise Program |
| Placebo Injection + Exercise | Placebo comparator | Participants will receive an equal volume of 0.9% saline administered intramuscularly into the deltoid under ultrasound guidance. Following the injection, participants will begin the same 12-week home-based exercise program performed 3 days per week. Receives: Drug: Intramuscular Saline Placebo Injection; Behavioral: Home-Based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Supraspinatus Tendon Elasticity Measured by Shear Wave Elastography
Supraspinatus tendon elasticity will be assessed using shear wave elastography (SWE). Measurements will be obtained from the tendon footprint and mid-substance regions, with at least three measurements taken from each region and the median value recorded. The change in tendon elasticity from baseline to week 12 will be evaluated.
Measured: Baseline and Week 12
Secondary outcomes (5)
Change in Shoulder Pain Measured by Visual Analog Scale (VAS)
Shoulder pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Rest pain, activity-related pain, and night pain will be recorded separately. Higher scores indicate greater pain severity.
Measured: Baseline, Week 6, and Week 12
Change in Shoulder Function Measured by Constant-Murley Score
Shoulder function will be assessed using the Constant-Murley Score, ranging from 0 to 100 points. The score evaluates pain, activities of daily living, range of motion, and strength. Higher scores indicate better shoulder function
Measured: Baseline, Week 6, and Week 12
Change in Upper Extremity Disability Measured by QuickDASH
Upper extremity disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire, scored from 0 to 100. Higher scores indicate greater disability and poorer upper extremity function.
Measured: Baseline, Week 6, and Week 12
Change in Shoulder Pain and Disability Measured by SPADI
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI), scored from 0 to 100. The scale includes pain and disability subscales. Higher scores indicate greater pain and disability.
Measured: Baseline, Week 6, and Week 12
Change in Health-Related Quality of Life Measured by SF-12
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The SF-12 provides a Physical Component Summary (PCS-12) score and a Mental Component Summary (MCS-12) score, each ranging from 0 to 100. Higher scores indicate better health status and health-related quality of life.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinopathyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.Rumeysa Türkoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.Rumeysa Türkoğlu, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Kadriye Banu Kuran, MD,Professor, Principal investigator, University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880522
- Sponsor's protocol ID
- RT-RC-2026-01
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no data-sharing plan was specified in the approved study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Subacromial Corticosteroid Injection Combined With an Exercise Program on Tendon Elastography and Clinical Outcomes in Rotator Cuff Pathologies: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07880522
- Acronym / sponsor ID
- RT-RC-2026-01
- Conditions
- Supraspinatus Tendinopathy
- Keywords
- Rotator Cuff, Supraspinatus, Subacromial Corticosteroid Injection, Shear Wave Elastography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Dr.Rumeysa TürkoğluUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Oct 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.
This prospective, randomized, double-blind, placebo-controlled clinical trial evaluates the effects of a subacromial corticosteroid injection combined with a 12-week home-based exercise program in patients aged 18 to 60 years with supraspinatus tendinopathy. A total of 56 participants will be randomized into two groups. The intervention group will receive an ultrasound-guided subacromial-subdeltoid injection of 20 mg triamcinolone acetonide plus saline, while the placebo group will receive an ultrasound-guided intramuscular saline injection into the deltoid. Both groups will follow the same 12-week exercise program. The primary outcome is the change in supraspinatus tendon elasticity measured by shear wave elastography. Secondary outcomes include pain, shoulder function, disability, and quality of life assessed using VAS, Constant-Murley Score, QuickDASH, SPADI, and SF-12.
Detailed description
Participants who meet the eligibility criteria and provide written informed consent will be randomized using a computer-based block randomization method. The corticosteroid group will receive an ultrasound-guided injection of 20 mg triamcinolone acetonide (1 mL) plus 1 mL saline into the subacromial-subdeltoid bursa. The placebo group will receive an equal volume of 0.9% saline administered intramuscularly into the deltoid under ultrasound guidance.
Following the injection, participants in both groups will begin the same 12-week home-based exercise program, performed three days per week for approximately 30-40 minutes per session. The program includes warm-up, scapular stabilization, rotator cuff strengthening, eccentric exercises, stretching, and mobility exercises, with progression according to pain level, muscle control, and exercise technique.
Shear wave elastography measurements of the supraspinatus tendon will be performed at baseline and at week 12. Clinical assessments, including VAS, SF-12, Constant-Murley Score, QuickDASH, and SPADI, will be performed at baseline, week 6, and week 12. The study aims to determine whether the addition of subacromial corticosteroid injection to exercise alters tendon elasticity and clinical outcomes compared with placebo injection plus exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subacromial Corticosteroid Injection + Exercise | Experimental | Drug: Subacromial Triamcinolone Acetonide Injection, Behavioral: Home-Based Exercise ProgramParticipants will receive an ultrasound-guided injection of 20 mg triamcinolone acetonide (1 mL) plus 1 mL saline into the subacromial-subdeltoid bursa. Following the injection, participants will begin a 12-week home-based exercise program performed 3 days per week. |
| Placebo Injection + Exercise | Placebo comparator | Drug: Intramuscular Saline Placebo Injection, Behavioral: Home-Based Exercise ProgramParticipants will receive an equal volume of 0.9% saline administered intramuscularly into the deltoid under ultrasound guidance. Following the injection, participants will begin the same 12-week home-based exercise program performed 3 days per week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 60 years.
- Unilateral shoulder pain in the dominant extremity lasting 3 to 12 months.
- At least 3 positive findings among the following clinical tests: painful arc test, Neer test, Hawkins test, Jobe test, and Full Can test.
- Tendinopathy or partial supraspinatus tear (<3 mm; mild/minimal partial tear) confirmed by MRI.
- Patte grade I and Goutallier grade 0-I on MRI.
Key exclusion criteria (14 listed)
- Full-thickness or advanced partial supraspinatus tear; Patte grade II-III and/or Goutallier grade II-IV.
- Acute trauma or infection.
- History of fracture or shoulder surgery.
- Adhesive capsulitis.
- Significant glenohumeral osteoarthritis.
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 |
|---|---|---|
| Subacromial Triamcinolone Acetonide InjectionA single ultrasound-guided injection of 20 mg triamcinolone acetonide (1 mL) plus 1 mL saline into the subacromial-subdeltoid bursa. | Drug | Subacromial Corticosteroid Injection + Exercise |
| Intramuscular Saline Placebo InjectionAn equal volume of 0.9% saline administered as a single ultrasound-guided intramuscular injection into the deltoid. | Drug | Placebo Injection + Exercise |
| Home-Based Exercise ProgramA 12-week home-based exercise program performed 3 days per week for approximately 30-40 minutes per session. The program includes warm-up, scapular stabilization, rotator cuff strengthening, eccentric exercises, stretching, and mobility exercises | Behavioural | Placebo Injection + Exercise, Subacromial Corticosteroid Injection + Exercise |
Primary outcome
Change in Supraspinatus Tendon Elasticity Measured by Shear Wave Elastography
Time frame: Baseline and Week 12
Supraspinatus tendon elasticity will be assessed using shear wave elastography (SWE). Measurements will be obtained from the tendon footprint and mid-substance regions, with at least three measurements taken from each region and the median value recorded. The change in tendon elasticity from baseline to week 12 will be evaluated.
5 secondary outcomes
Change in Shoulder Pain Measured by Visual Analog Scale (VAS)
Time frame: Baseline, Week 6, and Week 12
Change in Shoulder Function Measured by Constant-Murley Score
Time frame: Baseline, Week 6, and Week 12
Change in Upper Extremity Disability Measured by QuickDASH
Time frame: Baseline, Week 6, and Week 12
Change in Shoulder Pain and Disability Measured by SPADI
Time frame: Baseline, Week 6, and Week 12
Change in Health-Related Quality of Life Measured by SF-12
Time frame: Baseline, Week 6, and Week 12
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 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no data-sharing plan was specified in the approved study protocol.
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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. This study is not recruiting at the moment.
Kadriye Banu Kuran, MD,Professor principal investigator
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subacromial Triamcinolone Acetonide Injection and Home-Based Exercise Program in people with Supraspinatus Tendinopathy, run by Dr.Rumeysa Türkoğlu 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 6 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Supraspinatus Tendon Elasticity Measured by Shear Wave Elastography (time frame: Baseline and Week 12). 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 21 Oct 2026.