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

April 23, 2021 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and July 2020 with Supraspinatus tendinosis were prospectively recruited.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients treated by one-shot PRP injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogic Scale
Time Frame: Day 0; Month 1; Month 3; Month 6 (after the injection)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ACTUAL)

April 1, 2021

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (ACTUAL)

April 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP-shoulder

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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