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

Condition(s) studied

Investigational drug(s) / intervention(s)

Platelet-rich Plasma Local injection: Two procedures are considered for obtaining an equivalent PRP formulation, with the aim of establishing a contingency plan for possible situations such as a shortage of specific materials (extraction tubes) or the unavailability of a dedicated clean room for preparation under open circuit conditions. PRP produced in-house, following the open technique, is prepared in a laminar flow cabinet within an environment that complies with the standards of asepsis and Good Manufacturing Practices required for this type of preparation.

betamethasone and Ropivacaine: consists of a mixture of 2 cc of betamethasone and 2 cc of ropivacaine. To prepare it, 2 cc of betamethasone will be extracted from an ampoule of injectable solution using a sterile syringe (without attaching the needle) and mixed with 2 cc of ropivacaine.

Study summary

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. The comparison between these two options will determine whether platelet-rich plasma offers advantages in terms of clinical efficacy and duration of benefits. The results obtained could contribute significantly to the development of more effective protocols and more precise management guidelines for patients with chronic omalgia, thus addressing existing controversies and improving clinical practice.

Eligibility

Primary outcome measure(s)

• functional improvement between the intervention group and the control group measured by the absolute change in the Constant-Murley scale score — 36 months
  Evaluate the efficacy of two PRP injections versus two injections of betamethasone with ropivacaine, both combined with a personalized exercise program, in the treatment of chronic shoulder pain secondary to rotator cuff tendinopathy.

Trial sites (2)

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