Clinical Trials Directory

Trials / Completed

CompletedNCT07246434

Platelet-Rich Plasma Versus Home-Based Exercise for Partial-Thickness Supraspinatus Tears

Efficacy of Platelet-Rich Plasma Versus Home-Based Exercise in Patients With Partial-Thickness Supraspinatus Tears: A Prospective Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Universidad de Extremadura · Academic / Other
Sex
All
Age
20 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This study evaluates the clinical effectiveness of platelet-rich plasma (PRP) injections compared with a home-based exercise program in patients with partial-thickness tears of the supraspinatus tendon. Partial supraspinatus tears are a common cause of chronic shoulder pain and functional limitation. PRP has been proposed as a biological treatment that may promote tissue healing, while therapeutic exercise remains a standard conservative intervention. This prospective, controlled study includes two parallel groups. The PRP group receives three monthly ultrasound-guided intratendinous PRP injections, preceded by local anesthesia. The control group follows a structured home-based exercise program for the same overall treatment period. All participants are assessed at baseline and again two months after completing their assigned intervention. The primary outcome is shoulder pain measured with a Visual Analog Scale (VAS). Secondary outcomes include shoulder range of motion (flexion, extension, abduction, adduction, internal and external rotation) and functional disability measured with the Constant-Murley Score. The study also analyzes whether patient characteristics such as age or sex are associated with clinical improvement. The aim of this research is to compare two commonly used conservative treatment strategies and provide evidence to guide clinical decision-making for patients with partial-thickness supraspinatus tears.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPlatelet-Rich Plasma (PRP)Ultrasound-guided intratendinous injection of 4 mL PRP prepared from autologous blood using the BS PRP SYSTEM-20 kit. A total of three injections are administered at one-month intervals. Local anesthesia with 5 mL mepivacaine 2% is applied subacromially prior to PRP administration.
OTHERHome Exercise ProgramA supervised-prescribed home-based shoulder exercise program including mobility, strengthening, and scapular stabilization exercises. The program is performed regularly over approximately three months, with progression based on clinical guidelines for rotator cuff rehabilitation.

Timeline

Start date
2023-09-01
Primary completion
2024-04-30
Completion
2024-07-31
First posted
2025-11-24
Last updated
2025-11-24

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07246434. Inclusion in this directory is not an endorsement.

Platelet-Rich Plasma Versus Home-Based Exercise for Partial-Thickness Supraspinatus Tears (NCT07246434) · Clinical Trials Directory