Supraspinatus TendinitisNCT04851951
Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis
An observational study of Supraspinatus Tendinitis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraspinatus Tendinitis
- What is being tested?
- one-shot PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years old;
- Supraspinatus tendinosis detected by MRI.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, 70124
About this study
Official title: 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.
- Conditions
- Supraspinatus Tendinitis
- Being tested
- one-shot PRP injection
- Keywords
- Supraspinatus tendinosis; PRP; Shoulder;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-shot PRP injectionProcedure or surgery
A single injection of PRP (7% concentrate) ml 4 was made in the Supraspinatus tendon and in the Subacromial space under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| patients treated by one-shot PRP injection | Not described Receives: Procedure: one-shot PRP injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0; Month 1; Month 3; Month 6 (after the injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jan 2018
- Primary completion1 Jul 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851951
- Sponsor's protocol ID
- PRP-shoulder
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results Of Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis, Our Experience At Short-Term Follow Up
- ClinicalTrials.gov ID
- NCT04851951
- Acronym / sponsor ID
- PRP-shoulder
- Conditions
- Supraspinatus Tendinitis
- Keywords
- Supraspinatus tendinosis; PRP; Shoulder;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated by one-shot PRP injection | – | Procedure: one-shot PRP injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age > 18 years old;
- Supraspinatus tendinosis detected by MRI.
Key exclusion criteria (7 listed)
- Supraspinatus rupture;
- Previous shoulder surgery;
- Rotator cuff tears secondary to fracture;
- Hemoglobin <7 g/dL or Platelets < 30,000 microL;
- Active infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one-shot PRP injectionA single injection of PRP (7% concentrate) ml 4 was made in the Supraspinatus tendon and in the Subacromial space under ultrasound guidance. | Procedure or surgery | patients treated by one-shot PRP injection |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraspinatus Tendinitis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogic Scale (time frame: Day 0; Month 1; Month 3; Month 6 (after the injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.