E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Shoulder pain due to rotator cuff tendinopathy or partial tears of the supraspinatus tendon |
Dolor de hombro secundario a tendinopatía o rotura parcial del tendón del supraespinoso |
|
E.1.1.1 | Medical condition in easily understood language |
Shoulder pain due to tendon injury |
Dolor de hombro debido a lesión de los tendones del hombro |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
Evaluar la disminución del dolor tras la inyección eco-guiada con Plasma Rico en plaquetas o inyección de gran volumen en pacientes con dolor de hombro debido a tendinopatía o rotura parcial del tendón del supraespinoso |
|
E.2.2 | Secondary objectives of the trial |
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 |
Evaluar la mejora de la función del hombro mediante la inyección eco-guiada con Plasma Rico en plaquetas o inyección de gran volumen en pacientes con dolor de hombro debido a tendinopatía o rotura parcial del tendón del supraespinoso |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Shoulder pain due to tendinopathy or partial tear of the supraspinatus tendon for more than 3 months. |
Dolor de hombro debido a tendinopatía o rotura parcial del tendón del supraespinoso de más de 3 meses de evolucion. |
|
E.4 | Principal 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. |
- Embarazo. - Infección cutánea en la zona de la punción. - Enfermedad hematológica. - Antecedentes de sangrado. - Infección sistémica activa (VIH, VHC, Sepsis). - Enfermedad neoplásica activa. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Pain (VAS) -Function (Quick test Dash) |
-Dolor (EVA) -Función (Quick Test Dash) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1st visit 1.5 months. 3 months 6 months |
1 visita. 1.5 mes. 3 meses. 6 meses |
|
E.5.2 | Secondary end point(s) |
Cost-effectiveness analysis of treatment with PRP versus high volumen injection . |
Analisis del coste efectividad del tratamiento mediante PRP o injección de volumen. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1st visit 1.5 months. 3 months 6 months |
1 visita. 1.5 mes. 3 meses. 6 meses |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Saline Solution |
Saline Solution |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Ultima visita del último sujeto |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |