A Phase 4 interventional study of Autologous Platelet-Rich Plasma (PRP) and Dextrose 15% in Partial-Thickness Rotator Cuff Tear, sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Ankara Ataturk Sanatorium Training and Research Hospital · Phase 4, Interventional, and Treatment
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.
724 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 129 is above the median of 60 across 577 interventional studies indexed under Shoulder Pain.
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Participants received two ultrasound-guided subacromial injections of autologous platelet-rich plasma (PRP), two weeks apart, at weeks 0 and 2.
Biological: Autologous Platelet-Rich Plasma (PRP)
Participants received two ultrasound-guided subacromial injections of 15% dextrose solution for prolotherapy, two weeks apart, at weeks 0 and 2.
Drug: Dextrose 15%
Participants received a single ultrasound-guided subacromial corticosteroid injection at treatment initiation (week 0). Local anesthesia was administered separately at the injection site.
Drug: Betamethasone Sodium Phosphate and Betamethasone Acetate
Participants received a single ultrasound-guided subacromial saline injection at treatment initiation (week 0). Local anesthesia was administered separately at the injection site.
Drug: Sodium Chloride 0.9% (Control)
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.
Also known as: PRP
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.
Also known as: Dextrose Prolotherapy
Drug page: Betamethasone sodium phosphate
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.
Also known as: CALES
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.
Also known as: Normal Saline
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline immediately before the first injection, and 6, 12, and 24 weeks after the first injection.
Plan to share: No — There is no plan to make individual participant data collected in this study available to other researchers.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Platelet rich plasma · Glucose
Ankara Ataturk Sanatorium Training and Research Hospital