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

NCT07246434 | Completed

• 1 other identifier: 10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Rotator Cuff Injuries; Shoulder Joint; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain (VAS)

  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 Outcomes (4)

• Shoulder Range of Motion (Flexion, Extension, Abduction, Adduction, Internal and External Rotation)

  Baseline and 2 months after completing the intervention.

• Constant-Murley Score

  Baseline and 2 months post-intervention.

• Roles and Maudsley Score

  Baseline and 2 months post-intervention.

• QuickDASH Score

  Baseline and 2 months post-intervention.

Study Arms (2)

PRP Injection

EXPERIMENTAL

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.

Biological: Platelet-Rich Plasma (PRP)

Home-Based Exercise Program

ACTIVE COMPARATOR

Active Comparator

Other: Home Exercise Program

Interventions

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.

PRP Injection

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.

Home-Based Exercise Program

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

University of Extremadura

Badajoz, Badajoz, 06006, Spain

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Luis Espejo-Antúnez, Ph.D.

  University of Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Two-group prospective controlled design comparing PRP injections with a home-based exercise program in parallel arms.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: September 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

ES (1)