Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04851951
Recruitment Status : Completed
First Posted : April 21, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Supraspinatus Tendinitis Procedure: one-shot PRP injection

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Results Of Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis, Our Experience At Short-Term Follow Up
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : April 1, 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851951


Locations
Layout table for location information
Italy
AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, Italy, 70124
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
ClinicalTrials.gov Identifier: NCT04851951    
Other Study ID Numbers: PRP-shoulder
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari:
Supraspinatus tendinosis; PRP; Shoulder;
Additional relevant MeSH terms:
Layout table for MeSH terms
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries