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

NCT07448285 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-03-04

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

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.

DRUG

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.

Sponsors & Collaborators

  • Biobizkaia Health Research Institute

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-24
Primary Completion
2029-02-28
Completion
2029-04-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448285 on ClinicalTrials.gov