Partial-Thickness Rotator Cuff Tear
Conditions
Keywords
Platelet-Rich Plasma, Prolotherapy, Betamethasone, Subacromial Injection, Ultrasound-Guided Injection, Shoulder Pain
Brief 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.
Interventions
BIOLOGICALAutologous 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.
DRUGDextrose 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.
DRUGBetamethasone 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.
DRUGSodium 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.
Sponsors
Ankara Ataturk Sanatorium Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Active infection. * Use of anticoagulant medication. * Contraindication to any component of the study injections. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain Assessed Using the Visual Analog Scale (VAS) | 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 | 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 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed