PLATELET CONCENTRATE for Chronic omalgia|Rotator cuff tendinopathy

Inclusion criteria

• {"criterion_text":"-Patients aged between 35 and 75 years, both included."}
• {"criterion_text":"-Presence of pain in the affected shoulder with an intensity ≥3 points out of 10 on the visual analogue scale (VAS), assessed during the screening visit."}
• {"criterion_text":"-Body Mass Index (BMI) values between 20 and 27kg/m2, both values included."}
• {"criterion_text":"-Confirmed diagnosis of chronic omalgia associated with rotator cuff tendinopathy, following an unfavourable response to the standard regimen of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) for 4-6 weeks."}
• {"criterion_text":"-Patients who agree to participate in the study and sign the informed consent form."}

Exclusion criteria

• {"criterion_text":"-Confirmed diagnosis of complete rotator cuff tendon rupture."}
• {"criterion_text":"-Patients who are taking an investigational medicinal product or have participated in an investigational trial (with a licensed or unlicensed product) in the 30 days prior to randomisation."}
• {"criterion_text":"-Patient with any physical, social, or psychological impairment that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained from the patient's participation in the trial."}
• {"criterion_text":"-Pregnant women."}
• {"criterion_text":"-Breastfeeding women."}
• {"criterion_text":"-Women of childbearing age* who are unable or unwilling to use contraceptive methods with a failure rate <1% per year (bilateral tubal ligation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the four-week treatment period."}
• {"criterion_text":"-Patients with systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotising vasculitis)."}
• {"criterion_text":"-Poorly controlled diabetes mellitus, defined as glycosylated haemoglobin >9%."}
• {"criterion_text":"-Patients with haematological disorders (thrombopathy, thrombopenia, anaemias with Hb<9 g/dl)."}
• {"criterion_text":"-Patients undergoing immunosuppressive treatment."}
• {"criterion_text":"-Patients under treatment with intramuscular corticosteroids in the 3 months prior to the first administration of the trial treatment."}
• {"criterion_text":"-Patients on treatment with non-steroidal anti-inflammatory drugs (more than 10 consecutive days at usual doses), opioids or oral corticosteroids during the 15 days prior to study treatment."}
• {"criterion_text":"-Patients with severe heart disease."}
• {"criterion_text":"-Patients with active cancer or cancer diagnosed within the last 5 years."}

Primary endpoints

• {"endpoint_text":"-The difference in functional improvement between the intervention group (PRP infiltration combined with physical exercise) and the control group (corticosteroid infiltration combined with physical exercise), measured by the absolute change in the Constant-Murley scale (CMS) score at 6 months post-treatment, compared to the baseline score (14). An increase ≥ 10 points in the CMS score (15), in the absence of serious treatment-related complications, is considered a therapeutic success.","definition_or_measurement_approach":"Absolute change in Constant-Murley scale (CMS) score at 6 months post-treatment versus baseline; therapeutic success defined as an increase ≥ 10 points in CMS in absence of serious treatment-related complications."}

Spain

Earliest CTIS Part Ii Submission Date

12-06-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

130

Number Of Sites

2

Number Of Participants

86

Primary sponsor

Full Name

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain