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

ConditionChronic Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age35-75
SponsorBiobizkaia Health Research Institute

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 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 criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Platelet-rich Plasma Local injection
  • betamethasone and Ropivacaine

Treatment groups

86 Participants
are divided into 2 treatment groups