Clinical Trial to Evaluate the Efficacy and Safety of Platelet-rich Plasma Infiltration in Chronic Omalgia

Recruiting Phase 3 Interventional Study
Chronic Pain
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
35 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
86 (estimated)
Sponsor
Biobizkaia Health Research Institute · Government
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About This Trial
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…
Trial Locations
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Eligibility 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…
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