Partial-Thickness Rotator Cuff TearPhase 4NCT07871695
Injection Therapies for Partial Rotator Cuff Tears
A Phase 4 study testing Autologous Platelet-Rich Plasma (PRP), Dextrose 15% and Betamethasone Sodium Phosphate and Betamethasone Acetate in people with Partial-Thickness Rotator Cuff Tear, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This completed study compared four injection treatments in patients with painful partial tears of the rotator cuff, the tendons that help move and stabilize the shoulder. The aim was to compare changes in shoulder pain, shoulder function, and difficulty with everyday activities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Partial-Thickness Rotator Cuff Tear
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP), Dextrose 15% and Betamethasone Sodium Phosphate and Betamethasone Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 8 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Shoulder symptoms lasting at least 12 weeks.
- Magnetic resonance imaging (MRI)-confirmed partial-thickness rotator cuff tear involving less than 50% of tendon thickness.
Who cannot join
- Previous surgery on the affected shoulder.
- Full-thickness or high-grade partial-thickness rotator cuff tear.
- Adhesive capsulitis.
- Calcific tendinitis.
- Biceps tendinitis.
- Systemic inflammatory, neurological, or malignant disease.
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- Active infection.
- Use of anticoagulant medication.
- Contraindication to any component of the study injections.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Ataturk Sanatorium Training and Research Hospital
Ankara, Ankara, 06290
About this study
Official title: Comparison of Platelet-Rich Plasma, Prolotherapy, Corticosteroid, and Placebo Injections for Partial-Thickness Rotator Cuff Tears: A Randomized Controlled Trial
This completed study compared four injection treatments in patients with painful partial tears of the rotator cuff, the tendons that help move and stabilize the shoulder. The aim was to compare changes in shoulder pain, shoulder function, and difficulty with everyday activities.
Participants were assigned by chance to one of four treatment groups: platelet-rich plasma prepared from the patient's own blood, prolotherapy containing dextrose (a type of sugar), corticosteroid medication, or a saline placebo injection. Ultrasound was used to guide needle placement into the space above the rotator cuff tendons. The platelet-rich plasma and prolotherapy groups received two injections two weeks apart. The corticosteroid and placebo groups received one injection.
All groups followed the same rehabilitation program, starting two weeks after the first injection. Pain, shoulder function, and disability were assessed immediately before the first injection and at 6, 12, and 24 weeks after the first injection.
- Conditions
- Partial-Thickness Rotator Cuff Tear
- Being tested
- Autologous Platelet-Rich Plasma (PRP), Dextrose 15%, Betamethasone Sodium Phosphate and Betamethasone Acetate, Sodium Chloride 0.9% (Control)
- Keywords
- Platelet-Rich Plasma, Prolotherapy, Betamethasone, Subacromial Injection, Ultrasound-Guided Injection, Shoulder Pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma (PRP)Biological
Also called PRP
Autologous platelet-rich plasma was prepared using a double-spin centrifugation method. Approximately 4-5 mL was administered per injection into the subacromial space under ultrasound guidance using an in-plane technique. Two injections were administered two weeks apart, at weeks 0 and 2. No local anesthetic was added to the PRP.
Dextrose 15%Drug
Also called Dextrose Prolotherapy
Each injection consisted of 10 mL of 15% dextrose solution, prepared by mixing 3 mL of 50% dextrose with 7 mL of 0.9% sodium chloride. The entire prepared volume was injected into the subacromial space under ultrasound guidance using an in-plane technique. Two injections were administered two weeks apart, at weeks 0 and 2. Prilocaine 2% was administered locally at the injection site and was not mixed with the dextrose solution.
Betamethasone Sodium Phosphate and Betamethasone AcetateDrug
Also called CALES
A single subacromial injection was administered at week 0 under ultrasound guidance using an in-plane technique. The injectate consisted of 1 mL of CALES, containing betamethasone sodium phosphate equivalent to 3 mg of betamethasone plus 3 mg of betamethasone acetate, mixed with 1 mL of 0.9% sodium chloride, for a total subacromial volume of 2 mL. One milliliter of 2% prilocaine was administered separately at the injection site for local anesthesia and was not mixed with the subacromial injectate.
Sodium Chloride 0.9% (Control)Drug
Also called Normal Saline
A single injection of 3 mL of 0.9% sodium chloride was administered into the subacromial space at week 0 under ultrasound guidance using an in-plane technique. One milliliter of 2% prilocaine was administered separately at the injection site for local anesthesia and was not mixed with the saline injectate. The subacromial injectate contained no corticosteroid, platelet-rich plasma, or dextrose.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma (PRP) | Experimental | Participants received two ultrasound-guided subacromial injections of autologous platelet-rich plasma (PRP), two weeks apart, at weeks 0 and 2. Receives: Biological: Autologous Platelet-Rich Plasma (PRP) |
| Dextrose Prolotherapy | Experimental | Participants received two ultrasound-guided subacromial injections of 15% dextrose solution for prolotherapy, two weeks apart, at weeks 0 and 2. Receives: Drug: Dextrose 15% |
| Corticosteroid (Betamethasone) | Active comparator | Participants received a single ultrasound-guided subacromial corticosteroid injection at treatment initiation (week 0). Local anesthesia was administered separately at the injection site. Receives: Drug: Betamethasone Sodium Phosphate and Betamethasone Acetate |
| Saline Control (Placebo) | Placebo comparator | Participants received a single ultrasound-guided subacromial saline injection at treatment initiation (week 0). Local anesthesia was administered separately at the injection site. Receives: Drug: Sodium Chloride 0.9% (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain Assessed Using the Visual Analog Scale (VAS)
Shoulder pain intensity was assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10. Higher scores indicate more severe pain, and lower scores indicate a better outcome.
Measured: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.
Shoulder Function Assessed Using the Constant-Murley Score
Shoulder function was assessed using the Constant-Murley Score. The total score ranges from 0 to 100, with higher scores indicating better shoulder function.
Measured: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.
Shoulder Pain and Disability Index (SPADI) Total Score
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI). The total score ranges from 0 to 100, with higher scores indicating greater pain and disability and lower scores indicating a better outcome.
Measured: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Oct 2024
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-Thickness Rotator Cuff TearStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Semih Umut Çetin, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871695
- Sponsor's protocol ID
- 2024-KAEK-24/03
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data collected in this study available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Platelet-Rich Plasma, Prolotherapy, Corticosteroid, and Placebo Injections for Partial-Thickness Rotator Cuff Tears: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07871695
- Acronym / sponsor ID
- 2024-KAEK-24/03
- Conditions
- Partial-Thickness Rotator Cuff Tear
- Keywords
- Platelet-Rich Plasma, Prolotherapy, Betamethasone, Subacromial Injection, Ultrasound-Guided Injection, Shoulder Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 13 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 completed study compared four injection treatments in patients with painful partial tears of the rotator cuff, the tendons that help move and stabilize the shoulder. The aim was to compare changes in shoulder pain, shoulder function, and difficulty with everyday activities.
Participants were assigned by chance to one of four treatment groups: platelet-rich plasma prepared from the patient's own blood, prolotherapy containing dextrose (a type of sugar), corticosteroid medication, or a saline placebo injection. Ultrasound was used to guide needle placement into the space above the rotator cuff tendons. The platelet-rich plasma and prolotherapy groups received two injections two weeks apart. The corticosteroid and placebo groups received one injection.
All groups followed the same rehabilitation program, starting two weeks after the first injection. Pain, shoulder function, and disability were assessed immediately before the first injection and at 6, 12, and 24 weeks after the first injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma (PRP) | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP)Participants received two ultrasound-guided subacromial injections of autologous platelet-rich plasma (PRP), two weeks apart, at weeks 0 and 2. |
| Dextrose Prolotherapy | Experimental | Drug: Dextrose 15%Participants received two ultrasound-guided subacromial injections of 15% dextrose solution for prolotherapy, two weeks apart, at weeks 0 and 2. |
| Corticosteroid (Betamethasone) | Active comparator | Drug: Betamethasone Sodium Phosphate and Betamethasone AcetateParticipants received a single ultrasound-guided subacromial corticosteroid injection at treatment initiation (week 0). Local anesthesia was administered separately at the injection site. |
| Saline Control (Placebo) | Placebo comparator | Drug: Sodium Chloride 0.9% (Control)Participants received a single ultrasound-guided subacromial saline injection at treatment initiation (week 0). Local anesthesia was administered separately at the injection site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65 years.
- Shoulder symptoms lasting at least 12 weeks.
- Magnetic resonance imaging (MRI)-confirmed partial-thickness rotator cuff tear involving less than 50% of tendon thickness.
Key exclusion criteria (10 listed)
- Previous surgery on the affected shoulder.
- Full-thickness or high-grade partial-thickness rotator cuff tear.
- Adhesive capsulitis.
- Calcific tendinitis.
- Biceps tendinitis.
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 |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP)Also: PRPAutologous platelet-rich plasma was prepared using a double-spin centrifugation method. Approximately 4-5 mL was administered per injection into the subacromial space under ultrasound guidance using an in-plane technique. Two injections were administered two weeks apart, at weeks 0 and 2. No local anesthetic was added to the PRP. | Biological | Platelet-Rich Plasma (PRP) |
| Dextrose 15%Also: Dextrose ProlotherapyEach injection consisted of 10 mL of 15% dextrose solution, prepared by mixing 3 mL of 50% dextrose with 7 mL of 0.9% sodium chloride. The entire prepared volume was injected into the subacromial space under ultrasound guidance using an in-plane technique. Two injections were administered two weeks apart, at weeks 0 and 2. Prilocaine 2% was administered locally at the injection site and was not mixed with the dextrose solution. | Drug | Dextrose Prolotherapy |
| Betamethasone Sodium Phosphate and Betamethasone AcetateAlso: CALESA single subacromial injection was administered at week 0 under ultrasound guidance using an in-plane technique. The injectate consisted of 1 mL of CALES, containing betamethasone sodium phosphate equivalent to 3 mg of betamethasone plus 3 mg of betamethasone acetate, mixed with 1 mL of 0.9% sodium chloride, for a total subacromial volume of 2 mL. One milliliter of 2% prilocaine was administered separately at the injection site for local anesthesia and was not mixed with the subacromial injectate. | Drug | Corticosteroid (Betamethasone) |
| Sodium Chloride 0.9% (Control)Also: Normal SalineA single injection of 3 mL of 0.9% sodium chloride was administered into the subacromial space at week 0 under ultrasound guidance using an in-plane technique. One milliliter of 2% prilocaine was administered separately at the injection site for local anesthesia and was not mixed with the saline injectate. The subacromial injectate contained no corticosteroid, platelet-rich plasma, or dextrose. | Drug | Saline Control (Placebo) |
Primary outcome
Shoulder Pain Assessed Using the Visual Analog Scale (VAS)
Time frame: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.
Shoulder pain intensity was assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10. Higher scores indicate more severe pain, and lower scores indicate a better outcome.
Shoulder Function Assessed Using the Constant-Murley Score
Time frame: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.
Shoulder function was assessed using the Constant-Murley Score. The total score ranges from 0 to 100, with higher scores indicating better shoulder function.
Shoulder Pain and Disability Index (SPADI) Total Score
Time frame: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI). The total score ranges from 0 to 100, with higher scores indicating greater pain and disability and lower scores indicating a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data collected in this study available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autologous Platelet-Rich Plasma (PRP), Dextrose 15% and Betamethasone Sodium Phosphate and Betamethasone Acetate in people with Partial-Thickness Rotator Cuff Tear, run by Ankara Ataturk Sanatorium Training and Research Hospital 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 3 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: finished, as of the sponsor's last update on 13 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Shoulder Pain Assessed Using the Visual Analog Scale (VAS) (time frame: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.). The study lists 3 primary outcomes in all. 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 13 Oct 2026.