Platelet-rich plasma injections versus betamethasone plus ropivacaine for chronic shoulder (omalgia) pain
Randomized Clinical Trial to Evaluate the Efficacy and Safety of Platelet-Rich Plasma (PRP) Injection Combined With Physical Exercise in Chronic Omalgia
PHASE3 · Biobizkaia Health Research Institute · NCT07448285
This test will try platelet-rich plasma injections to see if they relieve chronic shoulder (omalgia) pain better and longer than a betamethasone plus ropivacaine injection in adults aged 35–75 with rotator cuff tendinopathy.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | Biobizkaia Health Research Institute (other gov) |
| Locations | 2 sites (Barakaldo, Bizkaia and 1 other locations) |
| Trial ID | NCT07448285 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 35–75 years old with at least three months of shoulder pain from rotator cuff tendinopathy, BMI 20–27, and persistent symptoms after 4–6 weeks of analgesic/NSAID treatment.
Not a fit: Patients with a complete rotator cuff tear, diabetes, systemic autoimmune disease, significant hematologic disorders, current immunosuppression, or very low hemoglobin/platelet counts are unlikely to qualify or benefit under this protocol.
Why it matters
Potential benefit: If successful, PRP could provide longer-lasting pain relief with fewer steroid exposures, improving function and helping define better treatment protocols for chronic shoulder pain.
How similar studies have performed: Previous randomized trials and meta-analyses of PRP for shoulder and tendon disorders have shown mixed results, with some studies reporting modest pain or functional gains but inconsistent overall benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Barakaldo, Bizkaia and 1 other locations
- Hospital Universitario Cruces — Barakaldo, Bizkaia, Spain (RECRUITING)
- Hospital Universitario Basurto — Bilbao, Bizkaia, Spain (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, omalgia