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Injection Therapies for Partial Rotator Cuff Tears
Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
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. 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.
Official title: Comparison of Platelet-Rich Plasma, Prolotherapy, Corticosteroid, and Placebo Injections for Partial-Thickness Rotator Cuff Tears: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2024-10-15
Completion Date
2026-01-08
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Autologous Platelet-Rich Plasma (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%
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 Acetate
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)
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.
Locations (1)
Ankara Ataturk Sanatorium Training and Research Hospital
Ankara, Ankara, Turkey (Türkiye)