Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis

Supraspinatus Tendinitis Clinical Trial

Official title:

Clinical Results Of Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis, Our Experience At Short-Term Follow Up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04851951
• Other study ID #: PRP-shoulder
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It was conducted a prospective study with a series of 50 patients treated with PRP one-shot injection in patient affected by Supraspinatus Tendinosis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection). Constant Score, The Disabilites of the Arm,Shoulder and Hand Score (DASH) And Visual Analogue Scale (VAS) were administered at each evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years old;
• Supraspinatus tendinosis detected by MRI.

Exclusion Criteria:

• Supraspinatus rupture;
• Previous shoulder surgery;
• Rotator cuff tears secondary to fracture;
• Hemoglobin <7 g/dL or Platelets < 30,000 microL;
• Active infection;
• Pregnant patients;
• Patients with hematologic and oncologic diseases.

Related Conditions & MeSH terms

• Supraspinatus Tendinitis
• Tendinopathy

Intervention

Procedure:
• one-shot PRP injection
A single injection of PRP (7% concentrate) ml 4 was made in the Supraspinatus tendon and in the Subacromial space under ultrasound guidance.

Locations

Country	Name	City	State
Italy	AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analogic Scale	The shoulder pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).	Day 0; Month 1; Month 3; Month 6 (after the injection)