Rotator Cuff InjuriesNCT07246434
Platelet-Rich Plasma Versus Home-Based Exercise for Partial-Thickness Supraspinatus Tears
A study testing Platelet-Rich Plasma (PRP) and Home Exercise Program in people with Rotator Cuff Injuries and Shoulder Joint, run by Universidad de Extremadura at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Joint, Shoulder Pain
- What is being tested?
- Platelet-Rich Plasma (PRP) and Home Exercise Program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Jul 2024
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Platelet-Rich Plasma (PRP), Home Exercise Program
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Platelet-Rich Plasma (PRP) |
| Home-Based Exercise Program | Active comparator | Active Comparator Receives: Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain (VAS)
Pain intensity measured using a 0-10 Visual Analog Scale (VAS). Higher scores indicate greater pain.
Measured: Baseline and 2 months after completing the intervention.
Secondary outcomes (4)
Shoulder Range of Motion (Flexion, Extension, Abduction, Adduction, Internal and External Rotation)
Active shoulder range of motion measured using standard goniometry in degrees.
Measured: Baseline and 2 months after completing the intervention.
Constant-Murley Score
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.
Measured: Baseline and 2 months post-intervention.
Roles and Maudsley Score
Four-point scale evaluating patient-perceived outcome (1 = excellent, 4 = poor).
Measured: Baseline and 2 months post-intervention.
QuickDASH Score
Disability and symptoms of the upper limb measured with the QuickDASH questionnaire (0-100 scale). Higher scores indicate greater disability.
Measured: Baseline and 2 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Sep 2023
- Primary completion30 Apr 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-group prospective controlled design comparing PRP injections with a home-based exercise program in parallel arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fernández-Morales, Universidad de Extremadura
- Investigators
- Luis Espejo-Antúnez, Ph.D., Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246434
- Sponsor's protocol ID
- 10
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-Rich Plasma Versus Home-Based Exercise in Patients With Partial-Thickness Supraspinatus Tears: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07246434
- Acronym / sponsor ID
- 10
- Conditions
- Rotator Cuff Injuries, Shoulder Joint, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 Nov 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group prospective controlled design comparing PRP injections with a home-based exercise program in parallel arms.
| Arm | Type | Receives |
|---|---|---|
| PRP Injection | Experimental | Biological: Platelet-Rich Plasma (PRP)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. |
| Home-Based Exercise Program | Active comparator | Other: Home Exercise ProgramActive Comparator |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Platelet-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. | Biological | PRP Injection |
| Home 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. | Other | Home-Based Exercise Program |
Primary outcome
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.
4 secondary outcomes
Shoulder Range of Motion (Flexion, Extension, Abduction, Adduction, Internal and External Rotation)
Time frame: Baseline and 2 months after completing the intervention.
Constant-Murley Score
Time frame: Baseline and 2 months post-intervention.
Roles and Maudsley Score
Time frame: Baseline and 2 months post-intervention.
QuickDASH Score
Time frame: Baseline and 2 months post-intervention.
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 24 Nov 2025.
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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.
Luis Espejo-Antúnez, Ph.D. study director
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma (PRP) and Home Exercise Program in people with Rotator Cuff Injuries and Shoulder Joint, run by Universidad de Extremadura at 1 site in Spain.
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 5 inclusion and 6 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 24 Nov 2025. 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 Spain. 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?
Shoulder Pain (VAS) (time frame: Baseline and 2 months after completing the intervention.). 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 24 Nov 2025.