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To compare the response of treatment with platelet rich plasma or saline solution injections in patients with shoulder pain.

Value of ultrasound-guided treatment with Platelet Rich Plasma or high volume injection in the rotator cuff tendon: Prospective randomized clinical trial. EudraCT number 2018-003709-25 - PRPVol

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2018-003709-25-ES
Enrollment
60
Registered
2019-04-12
Start date
2019-06-11
Completion date
Unknown
Last updated
2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder pain due to rotator cuff tendinopathy or partial tears of the supraspinatus tendon

Interventions

Trade Name: Platelet Rich Plasma Product Name: Platelet Rich Plasma Product Code: PRP Pharmaceutical Form: Blood fraction modifier INN o

Sponsors

Hospital Son Llatzer
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Shoulder pain due to tendinopathy or partial tear of the supraspinatus tendon for more than 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Pregnancy. - Cutaneous infection in the area of the puncture. - Hematological disease. - History of bleeding. - Active systemic infection (HIV, HCV, Sepsis). - Active neoplastic disease.

Design outcomes

Primary

MeasureTime frame
Primary end point(s): -Pain (VAS) -Function (Quick test Dash) ; Timepoint(s) of evaluation of this end point: 1st visit 1.5 months. 3 months 6 months ;Main Objective: To evaluate the shoulder pain after treatment with ultrasound guided injection of Platelet rich plasma or High volumen injection in patients with shoulder pain due to tendinopathy or partial tears of the supraspinatus tendon;Secondary Objective: To evaluate the shoulder function after treatment with ultrasound guided injection of Platelet rich plasma or High volumen injection in patients with shoulder pain due to tendinopathy or partial tears of the supraspinatus tendon

Secondary

MeasureTime frame
Secondary end point(s): Cost-effectiveness analysis of treatment with PRP versus high volumen injection .; Timepoint(s) of evaluation of this end point: 1st visit 1.5 months. 3 months 6 months

Countries

Spain

Contacts

Public ContactSecretaría Radiología

Hospital Son Llatzer

Españ0034678556372

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026