Rotator Cuff
Conditions
Interventions
This is a randomized, double-blind, controlled clinical trial that will be conducted with a total of 110 patients. Participants will be randomly allocated into two different groups: 1) Corticosteroid
2)injectable platelet-rich fibrin (i-PRF) group PLUS physiotherapy treatment (Intervention Group). In the screening process, participants will be registered and the following items will be checked: cl
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 65 years old; Shoulder pain and/or lateral deltoid; At least 3 months of symptoms; Physical examination with positive JOBE test, no pain in the acromioclavicular joint and no symptoms of instability; Tendinopathy/partial injury (less than 50%) of the supraspinatus muscle tendon confirmed by magnetic resonance imaging (MRI); no prior surgical intervention; agreement with the Free and Informed Consent Form (TCLE)
Exclusion criteria
Exclusion criteria: Body mass index greater than 18 and less than 35 kg/m2; pregnancy or lactation; systemic diseases (DM – glycated hemoglobin greater than 6.5); hematological disease (anemia, coagulopathy, thrombophilia); hemoglobin less than 11g/dL; Hematocrit less than 33%; Platelets less than150,000/µL; presence of another disease that could cause pain and dysfunction in the shoulder, such as arthritis or bone injury; such as arthritis or bone damage; ipsilateral limb orthopedic disease; rheumatological disease; chronic kidney disease on dialysis. Respiratory pathology (Rhinitis, Asthma, Chronic obstructive pulmonary disease); oncological disease; fibromyalgia or psychiatric pathology under treatment; chemical dependency (smoking, alcoholism, others); use of non-steroidal anti-inflammatory drugs in the last 30 days; use of glucocorticoids in the last 3 months (systemic, articular, topical, inhaled); Use of anticoagulants or antiplatelet agents; Anesthetic risk: ASA greater than or equal 3; patients receiving social security benefits (sickness benefit); limitation of range of motion compared to the contralateral side; partial injury, such as fissure, partial, fissure-type injury, partial rupture less than 50% or total of the supraspinatus tendon proven by magnetic resonance imaging; presence of acromion hooked seen on MRI; patients unwilling or unable to provide Free and Informed Consent Form (TCLE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of improvement in the visual analogue scale (VAS) for pain at 3, 6, 12 weeks, and at 6, 12 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of patient's reports on the use of analgesics and compliance with the rehabilitation protocol; analysis of scores to parameterize the assessments: American Shoulder and Elbow Surgeons (ASES) protocols and the Western Ontario Rotator Cuff index (WORC); evaluation of the appearance and thickness of the supraspinatus tendon using Doppler ultrasound and magnetic resonance imaging | — |
Countries
Brazil
Contacts
Public ContactPaulo Belangero
Universidade Federal de São Paulo
Outcome results
None listed