Partial Rotator Cuff TearsNCT07688902
Intralesional Versus Perilesional 5% Dextrose Injection in Partial Rotator Cuff Tears
A study testing Intralesional 5% Dextrose Injection and Perilesional 5% Dextrose Injection in people with Partial Rotator Cuff Tears and Rotator Cuff Tendinopathy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind controlled clinical trial aims to compare the clinical and ultrasonographic outcomes of intralesional and perilesional 5% dextrose injection in patients with partial rotator cuff tears. Eligible participants will be randomized into two parallel groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Partial Rotator Cuff Tears, Rotator Cuff Tendinopathy, Shoulder Pain Chronic
- What is being tested?
- Intralesional 5% Dextrose Injection and Perilesional 5% Dextrose Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of partial rotator cuff tear by a specialist physician after appropriate clinical examination and imaging evaluation
- Shoulder pain and functional limitation lasting for at least 3 months
- Clinically confirmed shoulder impingement findings, defined as at least one positive test among Neer, Hawkins-Kennedy, or painful arc tests
- Age between 18 and 75 years
- Ability to comply with the study procedures and attend follow-up visits regularly
- Willingness to participate in the study and provide written informed consent
Who cannot join
- Advanced cognitive impairment or dementia preventing reliable completion of questionnaires
- Refusal to participate in the study or inability to provide informed consent
- Full-thickness rotator cuff tear
- Major tendon pathology other than the supraspinatus tendon, such as full-thickness subscapularis tear or biceps tendon rupture
- Advanced acromioclavicular joint osteoarthritis, marked impingement, or marked adhesive capsulitis
- Advanced glenohumeral joint arthritis
Show all 17Show fewer
- Active infection, cellulitis, or dermatologic lesion at the injection site
- Bleeding diathesis or anticoagulant use
- Known allergy or intolerance to dextrose injection
- Intra-articular shoulder injection, including steroid, platelet-rich plasma, or prolotherapy, within the last 3 months
- Previous shoulder surgery
- Uncontrolled diabetes mellitus, defined as HbA1c >8.5%, or severe endocrine or metabolic disorder
- Immunosuppression or active infection
- Rheumatologic shoulder involvement
- Neurological disease affecting shoulder movements
- Pregnancy
- Active malignancy
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
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Ankara
Esra Ülgen Kıratlıoğlu, +905079614194, esraulgen@gmail.com
About this study
Official title: Comparison of Clinical and Ultrasonographic Outcomes of Intralesional and Perilesional 5% Dextrose Injection in Patients With Partial Rotator Cuff Tears: A Prospective Randomized Double-Blind Controlled Trial
This prospective, randomized, double-blind controlled clinical trial aims to compare the clinical and ultrasonographic outcomes of intralesional and perilesional 5% dextrose injection in patients with partial rotator cuff tears. Eligible participants will be randomized into two parallel groups. Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, one group will receive intralesional 5% dextrose injection, while the other group will receive perilesional 5% dextrose injection using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. Clinical outcomes will be assessed at baseline, 9 weeks, and 12 weeks after treatment, and ultrasonographic outcomes will be assessed at baseline and 12 weeks.
Read the detailed description
Rotator cuff tears are one of the leading causes of shoulder pain and functional limitation. Partial rotator cuff tears may become chronic and may not respond adequately to conventional conservative treatments such as activity modification, physical therapy, and nonsteroidal anti-inflammatory drugs.
Dextrose injection is a regenerative injection therapy that aims to stimulate tissue healing responses in chronic musculoskeletal disorders. It is thought to promote fibroblast activation, collagen synthesis, and proliferative healing processes in degenerative tendon, ligament, and enthesis lesions. Ultrasound guidance allows accurate and safe delivery of the injectate to the target tissue and enables objective follow-up of tendon morphology during the treatment process.
This study will include adult patients with partial rotator cuff tears diagnosed by clinical examination and imaging. Participants will be randomized into two groups using a computer-based random number system. The researcher performing the randomization will know the treatment allocation, while the participants and the physician assessing the clinical outcomes will be blinded to treatment groups.
Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. The intralesional group will additionally receive intralesional 5% dextrose injection, and the perilesional group will additionally receive perilesional 5% dextrose injection. Injections will be applied using the peppering technique, with 0.1-0.2 cc administered to each point. A total of three treatment sessions will be performed at 21-day intervals.
Clinical outcomes will include shoulder pain assessed by the Numeric Rating Scale, shoulder pain and disability assessed by the Shoulder Pain and Disability Index, and health-related quality of life assessed by the Short Form-12 Health Survey. Ultrasonographic outcomes will include supraspinatus tendon thickness and partial defect size. Clinical evaluations will be performed at baseline, 9 weeks, and 12 weeks after treatment. Ultrasonographic evaluations will be performed at baseline and 12 weeks.
- Conditions
- Partial Rotator Cuff Tears, Rotator Cuff Tendinopathy, Shoulder Pain Chronic, Supraspinatus Tendon Tear
- Being tested
- Intralesional 5% Dextrose Injection, Perilesional 5% Dextrose Injection
- Keywords
- Dextrose injection, Prolotherapy, Intralesional injection, Perilesional injection, Partial rotator cuff tear, Supraspinatus tendon, Ultrasound-guided injection, Shoulder Pain and Disability Index, Numeric Rating Scale, Ultrasonography
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional 5% Dextrose InjectionProcedure or surgery
Ultrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally into the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals.
Perilesional 5% Dextrose InjectionProcedure or surgery
Ultrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally around the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional 5% Dextrose Injection | Experimental | Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, intralesional 5% dextrose injection will be applied to the partial rotator cuff tear using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. Receives: Procedure: Intralesional 5% Dextrose Injection |
| Perilesional 5% Dextrose Injection | Active comparator | Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, perilesional 5% dextrose injection will be applied around the partial rotator cuff tear using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. Receives: Procedure: Perilesional 5% Dextrose Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
Shoulder pain intensity will be assessed using the Numeric Rating Scale. Night pain, worst daytime shoulder pain, and average shoulder pain will be evaluated on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: Baseline, 9 weeks, and 12 weeks after treatment
Secondary outcomes (4)
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. The scale consists of 13 items in two domains: pain and disability. Each item is scored from 0 to 10, and the total score is converted to a 0-100 scale. Higher scores indicate greater pain and functional impairment.
Measured: Baseline, 9 weeks, and 12 weeks after treatment
Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey
Health-related quality of life will be assessed using the Short Form-12 Health Survey. The questionnaire includes 12 items and provides physical component summary and mental component summary scores. Higher scores indicate better health-related quality of life.
Measured: Baseline, 9 weeks, and 12 weeks after treatment
Change in Supraspinatus Tendon Thickness Assessed by Ultrasonography
Supraspinatus tendon thickness will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
Measured: Baseline and 12 weeks after treatment
Change in Partial Rotator Cuff Defect Size Assessed by Ultrasonography
Partial rotator cuff defect size will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
Measured: Baseline and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Feb 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Rotator Cuff TearsStudies 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
- Model description
- Participants will be randomized into two parallel groups: intralesional 5% dextrose injection and perilesional 5% dextrose injection.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent
- Investigators
- ESRA Ülgen Kıratlıoğlu, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688902
- Sponsor's protocol ID
- E2-26-14590
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 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 due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Ultrasonographic Outcomes of Intralesional and Perilesional 5% Dextrose Injection in Patients With Partial Rotator Cuff Tears: A Prospective Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07688902
- Acronym / sponsor ID
- E2-26-14590
- Conditions
- Partial Rotator Cuff Tears, Rotator Cuff Tendinopathy, Shoulder Pain Chronic, Supraspinatus Tendon Tear
- Keywords
- Dextrose injection, Prolotherapy, Intralesional injection, Perilesional injection, Partial rotator cuff tear, Supraspinatus tendon, Ultrasound-guided injection, Shoulder Pain and Disability Index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Jul 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 controlled clinical trial aims to compare the clinical and ultrasonographic outcomes of intralesional and perilesional 5% dextrose injection in patients with partial rotator cuff tears. Eligible participants will be randomized into two parallel groups. Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, one group will receive intralesional 5% dextrose injection, while the other group will receive perilesional 5% dextrose injection using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. Clinical outcomes will be assessed at baseline, 9 weeks, and 12 weeks after treatment, and ultrasonographic outcomes will be assessed at baseline and 12 weeks.
Detailed description
Rotator cuff tears are one of the leading causes of shoulder pain and functional limitation. Partial rotator cuff tears may become chronic and may not respond adequately to conventional conservative treatments such as activity modification, physical therapy, and nonsteroidal anti-inflammatory drugs.
Dextrose injection is a regenerative injection therapy that aims to stimulate tissue healing responses in chronic musculoskeletal disorders. It is thought to promote fibroblast activation, collagen synthesis, and proliferative healing processes in degenerative tendon, ligament, and enthesis lesions. Ultrasound guidance allows accurate and safe delivery of the injectate to the target tissue and enables objective follow-up of tendon morphology during the treatment process.
This study will include adult patients with partial rotator cuff tears diagnosed by clinical examination and imaging. Participants will be randomized into two groups using a computer-based random number system. The researcher performing the randomization will know the treatment allocation, while the participants and the physician assessing the clinical outcomes will be blinded to treatment groups.
Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. The intralesional group will additionally receive intralesional 5% dextrose injection, and the perilesional group will additionally receive perilesional 5% dextrose injection. Injections will be applied using the peppering technique, with 0.1-0.2 cc administered to each point. A total of three treatment sessions will be performed at 21-day intervals.
Clinical outcomes will include shoulder pain assessed by the Numeric Rating Scale, shoulder pain and disability assessed by the Shoulder Pain and Disability Index, and health-related quality of life assessed by the Short Form-12 Health Survey. Ultrasonographic outcomes will include supraspinatus tendon thickness and partial defect size. Clinical evaluations will be performed at baseline, 9 weeks, and 12 weeks after treatment. Ultrasonographic evaluations will be performed at baseline and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: intralesional 5% dextrose injection and perilesional 5% dextrose injection.
| Arm | Type | Receives |
|---|---|---|
| Intralesional 5% Dextrose Injection | Experimental | Procedure: Intralesional 5% Dextrose InjectionParticipants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, intralesional 5% dextrose injection will be applied to the partial rotator cuff tear using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. |
| Perilesional 5% Dextrose Injection | Active comparator | Procedure: Perilesional 5% Dextrose InjectionParticipants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, perilesional 5% dextrose injection will be applied around the partial rotator cuff tear using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of partial rotator cuff tear by a specialist physician after appropriate clinical examination and imaging evaluation
- Shoulder pain and functional limitation lasting for at least 3 months
- Clinically confirmed shoulder impingement findings, defined as at least one positive test among Neer, Hawkins-Kennedy, or painful arc tests
- Age between 18 and 75 years
- Ability to comply with the study procedures and attend follow-up visits regularly
Key exclusion criteria (17 listed)
- Advanced cognitive impairment or dementia preventing reliable completion of questionnaires
- Refusal to participate in the study or inability to provide informed consent
- Full-thickness rotator cuff tear
- Major tendon pathology other than the supraspinatus tendon, such as full-thickness subscapularis tear or biceps tendon rupture
- Advanced acromioclavicular joint osteoarthritis, marked impingement, or marked adhesive capsulitis
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 |
|---|---|---|
| Intralesional 5% Dextrose InjectionUltrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally into the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals. | Procedure or surgery | Intralesional 5% Dextrose Injection |
| Perilesional 5% Dextrose InjectionUltrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally around the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals. | Procedure or surgery | Perilesional 5% Dextrose Injection |
Primary outcome
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
Time frame: Baseline, 9 weeks, and 12 weeks after treatment
Shoulder pain intensity will be assessed using the Numeric Rating Scale. Night pain, worst daytime shoulder pain, and average shoulder pain will be evaluated on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
4 secondary outcomes
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
Time frame: Baseline, 9 weeks, and 12 weeks after treatment
Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey
Time frame: Baseline, 9 weeks, and 12 weeks after treatment
Change in Supraspinatus Tendon Thickness Assessed by Ultrasonography
Time frame: Baseline and 12 weeks after treatment
Change in Partial Rotator Cuff Defect Size Assessed by Ultrasonography
Time frame: Baseline and 12 weeks after treatment
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 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and ethical restrictions.
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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.
ESRA Ülgen Kıratlıoğlu principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralesional 5% Dextrose Injection and Perilesional 5% Dextrose Injection in people with Partial Rotator Cuff Tears and Rotator Cuff Tendinopathy, run by Ankara City Hospital Bilkent 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 17 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 Jul 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 Esra Ülgen Kıratlıoğlu, MD (+905079614194, esraulgen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale (time frame: Baseline, 9 weeks, and 12 weeks after treatment). 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 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.