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Tests treatment safety and results for Chronic Pain
Official title Clinical Trial to Evaluate the Efficacy and Safety of Platelet-rich Plasma Infiltration in Chronic Omalgia
ClinicalTrials.gov ID: NCT07448285
What this study is testing
What is Platelet-rich Plasma Local injection?
Platelet-rich Plasma Local injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for chronic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The experimental group will receive intralesional injections of platelet-rich plasma, evaluating its ability to relieve pain and provide sustained improvement through biological modulation of the joint and tendon environment. In contrast, the control group will be treated with a combination of betamethasone and ropivacaine, representing the current standard of care for short-term inflammatory pain management.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- 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...
- 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 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.
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Barakaldo, Bizkaia, Spain
- Bilbao, Bizkaia, Spain
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, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barakaldo, Bizkaia, Spain; Bilbao, Bizkaia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.