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

Phase 1

• Conditions: Shoulder pain due to rotator cuff tendinopathy or partial tears of the supraspinatus tendon; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-003709-25-ES
• Lead Sponsor: Hospital Son Llatzer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary end point(s): -Pain (VAS)<br> -Function (Quick test Dash)<br> ;<br> Timepoint(s) of evaluation of this end point: 1st visit<br> 1.5 months.<br> 3 months<br> 6 months<br> ;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Cost-effectiveness analysis of treatment with PRP versus high volumen injection .;<br> Timepoint(s) of evaluation of this end point: 1st visit<br> 1.5 months.<br> 3 months<br> 6 months<br>