Study of Platelet-Rich Plasma Injections Combined with Exercise Compared to Betamethasone and Ropivacaine for Chronic Shoulder Pain Treatment

3 1 1 1

What is this study about?

This clinical trial focuses on treating chronic omalgia, which is persistent shoulder pain associated with rotator cuff tendinopathy – a condition affecting the tendons in the shoulder. The study compares two different treatment approaches to help patients with shoulder pain that hasn’t responded to standard pain medications.

The study will test two treatments: platelet-rich plasma (PRP) injections, which use concentrated platelets from the patient’s own blood, compared to injections containing betamethasone (a steroid) and ropivacaine (a pain medication). Both groups of patients will also follow a personalized exercise program. The main goal is to determine if PRP injections combined with exercise are more effective at reducing shoulder pain and improving function than steroid injections with exercise.

During the study, patients will receive two injections of either PRP or the combination of betamethasone and ropivacaine. The treatment period lasts up to 15 days, and patients will be monitored for changes in their shoulder function and pain levels over six months. The effectiveness of the treatment will be measured using a special scoring system that evaluates shoulder function and pain.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups: either platelet-rich plasma (PRP) injections or betamethasone with ropivacaine injections.

Both groups will receive a personalized exercise program as part of the treatment.

2 Treatment administration – First injection

You will receive your first injection treatment based on your assigned group.

The injection will be administered directly into the affected shoulder area.

3 Treatment administration – Second injection

You will receive a second injection of the same treatment as your first injection.

The injection will be administered into the same shoulder area.

4 Exercise program participation

Throughout the study period, you will follow a personalized exercise program designed specifically for your condition.

The exercises will focus on improving your shoulder function.

5 Progress evaluation

Your shoulder function will be measured using the Constant-Murley scale, which assesses shoulder performance and pain levels.

The main evaluation will take place 6 months after your treatment begins.

The evaluation will compare your shoulder function to your initial condition before treatment.

6 Study completion

The study will track your progress for 6 months after treatment.

Your participation will help determine which treatment is more effective for chronic shoulder pain (chronic omalgia).

Who Can Join the Study?

Age requirement: Must be between 35 and 75 years old
Must have shoulder pain with a severity of at least 3 out of 10 on the pain scale when checked during the first visit
Body weight requirements: Must have a Body Mass Index (BMI) between 20 and 27 (BMI is a measure calculated from your weight and height)
Must have been diagnosed with chronic shoulder pain related to rotator cuff tendinopathy (a condition affecting the tendons in the shoulder) that hasn’t improved after 4-6 weeks of regular pain medications and anti-inflammatory drugs
Must be willing to participate in the study and provide written consent by signing the appropriate forms

Who Cannot Join the Study?

Age under 18 or over 65 years
Previous shoulder surgery or injury in the past 3 months
Current rotator cuff tear (damage to the muscles and tendons around the shoulder)
Active infection in the shoulder area
Current use of blood-thinning medications (anticoagulants)
Ongoing cancer treatment
Pregnancy or breastfeeding
Known allergies to local anesthetics or corticosteroids
Current participation in another clinical trial
Presence of other significant shoulder conditions that could affect the study results
Inability to follow the prescribed exercise program
Uncontrolled diabetes mellitus (high blood sugar disease)
Active inflammatory joint disease (such as rheumatoid arthritis)
History of adverse reactions to steroid injections
Severe chronic pain conditions affecting other parts of the body

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Basurto	Bilbao	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	15.12.2025

Trial locations

Investigated drugs:

Platelet-Rich Plasma (PRP)
This is a preparation made from a patient’s own blood. It contains a high concentration of platelets, which release growth factors that can help heal injured tissues. In this trial, it’s used as an injection to treat shoulder pain related to rotator cuff problems.

Betamethasone
This is a corticosteroid medication that helps reduce inflammation and pain. It’s commonly used in injection form to treat various joint and muscle conditions. In this trial, it’s used as an injection for shoulder pain treatment.

Ropivacaine
This is a local anesthetic medication that helps reduce pain by numbing the area where it’s injected. It’s used together with betamethasone in this trial to provide pain relief for shoulder conditions.

Physical Exercise
While not a medication, this therapy is an important part of the treatment plan. It involves personalized exercise programs designed specifically for patients with shoulder pain from rotator cuff problems.

Chronic Omalgia – A persistent condition characterized by shoulder pain that lasts for an extended period. It commonly develops due to inflammation or damage to the rotator cuff tendons, which are essential for shoulder movement and stability. The condition typically causes pain during arm movement, especially when lifting or reaching overhead. Patients often experience discomfort during daily activities and may have reduced range of motion in the affected shoulder. The pain can vary from mild to severe and may worsen with certain movements or activities. The condition can develop gradually over time, often affecting one shoulder more than the other.

Trial ID:

2025-522700-24-00

Protocol code:

SHIELD-PRP

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider