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NCT Number: NCT07246434

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

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.

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Key information

Conditions

Rotator Cuff Injuries Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rupture Shoulder Injuries Shoulder Joint Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Extremadura

Badajoz, 06006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Platelet-Rich Plasma (PRP)

Biological

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.

Home exercise program

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Roles and Maudsley Score

    Time frame: Baseline and 2 months post-intervention.

    Four-point scale evaluating patient-perceived outcome (1 = excellent, 4 = poor).

  4. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Extremadura

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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