- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07246434
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Badajoz
-
Badajoz, Badajoz, Spain, 06006
- University of Extremadura
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 20 and 70 years.
Shoulder pain for more than 6 months with a Visual Analog Scale (VAS) score > 4.
Partial-thickness tear of the supraspinatus tendon confirmed by ultrasound.
No improvement in VAS after conservative treatment with NSAIDs and/or physical therapy during the previous 6 months.
Willingness to undergo blood extraction and PRP infiltrations as required by the protocol.
Exclusion Criteria:
- Age < 20 or > 70 years.
Full-thickness tear of the supraspinatus tendon.
Active infection (osteomyelitis, septic arthritis).
Current treatment with NSAIDs, antiplatelet agents, or systemic immunosuppressants.
Severe thrombocytopenia.
Positive serology (syphilis, HIV, HBV, HCV).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRP Injection
Participants receive three monthly ultrasound-guided intratendinous injections of platelet-rich plasma (PRP) in the affected supraspinatus tendon, preceded by local anesthetic infiltration in the subacromial bursa.
|
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.
|
|
Active Comparator: Home-Based Exercise Program
Active Comparator
|
A 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain (VAS)
Time Frame: Baseline and 2 months after completing the intervention.
|
Pain intensity measured using a 0-10 Visual Analog Scale (VAS).
Higher scores indicate greater pain.
|
Baseline and 2 months after completing the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Range of Motion (Flexion, Extension, Abduction, Adduction, Internal and External Rotation)
Time Frame: Baseline and 2 months after completing the intervention.
|
Active shoulder range of motion measured using standard goniometry in degrees.
|
Baseline and 2 months after completing the intervention.
|
|
Constant-Murley Score
Time Frame: Baseline and 2 months post-intervention.
|
Composite functional score assessing pain, daily activities, range of motion, and strength.
Total score ranges from 0 to 100; higher scores indicate better shoulder function.
|
Baseline and 2 months post-intervention.
|
|
Roles and Maudsley Score
Time Frame: Baseline and 2 months post-intervention.
|
Four-point scale evaluating patient-perceived outcome (1 = excellent, 4 = poor).
|
Baseline and 2 months post-intervention.
|
|
QuickDASH Score
Time Frame: Baseline and 2 months post-intervention.
|
Disability and symptoms of the upper limb measured with the QuickDASH questionnaire (0-100 scale).
Higher scores indicate greater disability.
|
Baseline and 2 months post-intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Luis Espejo-Antúnez, Ph.D., University of Extremadura
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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