Platelet-rich plasma injections versus betamethasone plus ropivacaine for chronic shoulder (omalgia) pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized interventional study compares intralesional platelet-rich plasma (PRP) injections to a standard combination of betamethasone and ropivacaine in adults with chronic shoulder pain due to rotator cuff tendinopathy. Participants aged 35–75 with at least three months of shoulder pain and a BMI of 20–27 who did not improve after 4–6 weeks of analgesic/NSAID therapy will be enrolled and randomly assigned to one of the two local injection treatments. Outcomes focus on pain relief, duration of benefit, functional change, and safety with scheduled follow-up visits. The trial is conducted at two tertiary hospitals in Bizkaia, Spain, using standardized PRP preparation and local injection procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients between 35 and 75 years of age, both inclusive.
* Presence of pain in the affected shoulder for 3 or more months.
* Body Mass Index (BMI) values between 20 and 27 kg/m2, including both values.
* Confirmed diagnosis of chronic shoulder pain associated with rotator cuff tendinopathy, following an unfavorable response to standard treatment with analgesics and nonsteroidal anti-inflammatory drugs for 4-6 weeks.
* Patients who agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Confirmed diagnosis of complete rotator cuff tear.
* Patients with systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
* Patients with diabetes mellitus.
* Patients with hematological disorders (thrombopathy, thrombocytopenia, anemia with Hb\<9 g/dl).
* Patients undergoing immunosuppressive treatment at the time of inclusion.
* Patients undergoing treatment with intramuscular corticosteroids in the 3 months prior to the first administration of the trial treatment.
* Patients undergoing treatment with nonsteroidal anti-inflammatory drugs (more than 10 consecutive days at usual doses), opioids, or oral corticosteroids during the 15 days prior to treatment in the study.
* Patients with severe heart disease.
* Patients with active cancer or cancer diagnosed in the last 5 years.
* Patients who are taking a drug in clinical trials or have participated in any clinical trial (with an authorized or unauthorized product) in the 30 days prior to randomization.
* Patients with any physical, social, or psychological condition that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained from their participation in it.
* Pregnant women.
* Breastfeeding women.
* Women of childbearing age\* who are unable or unwilling to use contraceptive methods with a failure rate of \<1% per year (bilateral tubal ligation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the four-week treatment period.

Where it's running

• Hospital Universitario Cruces
  Barakaldo, Bizkaia, Spain Recruiting
• Hospital Universitario Basurto
  Bilbao, Bizkaia, Spain Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.