BridgeMD
RANDOMISED CLINICAL STUDY TO ASSESS THE EFFICACY AND SAFETY OF PLATELET-RICH PLASMA (PRP) INFILTRATION COMBINED WITH PHYSICAL EXERCISE IN CHRONIC OMALGIA
EU CTIS ID: 2025-522700-24-00
What this study is testing
To evaluate the efficacy of two PRP injections compared to two betamethasone + ropivacaine injections, both supplemented with a personalised exercise programme, for the treatment of chronic omalgia secondary to rotator cuff tendinopathy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged between 35 and 75 years, both included.
- Presence of pain in the affected shoulder with an intensity ≥3 points out of 10 on the visual analogue scale (VAS), assessed during the screening visit.
- Body Mass Index (BMI) values between 20 and 27kg/m2, both values included.
- Confirmed diagnosis of chronic omalgia associated with rotator cuff tendinopathy, following an unfavourable response to the standard regimen of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) for 4-6 weeks.
- Patients who agree to participate in the study and sign the informed consent form.
You likely can't join if
- Confirmed diagnosis of complete rotator cuff tendon rupture.
- Patients who are taking an investigational medicinal product or have participated in an investigational trial (with a licensed or unlicensed product) in the 30 days prior to randomisation.
- Patient with any physical, social, or psychological impairment that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained from the patient's participation in the trial.
- Pregnant women.
- Breastfeeding women.
- Women of childbearing age* who are unable or unwilling to use contraceptive methods with a failure rate <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.
See the full eligibility criteria
- Patients aged between 35 and 75 years, both included.
- Presence of pain in the affected shoulder with an intensity ≥3 points out of 10 on the visual analogue scale (VAS), assessed during the screening visit.
- Body Mass Index (BMI) values between 20 and 27kg/m2, both values included.
- Confirmed diagnosis of chronic omalgia associated with rotator cuff tendinopathy, following an unfavourable response to the standard regimen of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) for 4-6 weeks.
- Patients who agree to participate in the study and sign the informed consent form.
- Confirmed diagnosis of complete rotator cuff tendon rupture.
- Patients who are taking an investigational medicinal product or have participated in an investigational trial (with a licensed or unlicensed product) in the 30 days prior to randomisation.
- Patient with any physical, social, or psychological impairment that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained from the patient's participation in the trial.
- Pregnant women.
- Breastfeeding women.
- Women of childbearing age* who are unable or unwilling to use contraceptive methods with a failure rate <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.
- Patients with systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotising vasculitis).
- Poorly controlled diabetes mellitus, defined as glycosylated haemoglobin >9%.
- Patients with haematological disorders (thrombopathy, thrombopenia, anaemias with Hb<9 g/dl).
- Patients undergoing immunosuppressive treatment.
- Patients under treatment with intramuscular corticosteroids in the 3 months prior to the first administration of the trial treatment.
- Patients on treatment with non-steroidal anti-inflammatory drugs (more than 10 consecutive days at usual doses), opioids or oral corticosteroids during the 15 days prior to study treatment.
- Patients with severe heart disease.
- Patients with active cancer or cancer diagnosed within the last 5 years.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.