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.
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…
Contacts
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