Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT04231357
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes between the ages of 35 and 75 years.
* At the screening visit, they present hip pain at 3 points out of 10 in EVA.
* Body Mass Index values between 20 and 35 (both values included).
* Commitment to comply with all study procedures.
* Diagnoses of chronic GTPS according to the diagnostic criteria that have been previously described.
* The patient must give written informed consent.
* Women of child-bearing age must obtain a negative test result of pregnancy in blood or urine and accept the use of appropriate contraception while in the trial.
Exclusion Criteria:
* • Body Mass Index\>35.
* Presence of full tendon tear.
* Systemic autoimmune rheumatologic disease (connective tissue diseases and systemic necrotizing vasculitis)
* Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
* Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb \<9)
* Patients receiving immunosuppressive treatments
* Treatment by intramuscular corticoid, during the 3 months prior to the first administration of the trial treatment.
* Treatment with non-steroidal anti-inflammatory drugs (more than 10 days consecutive to usual doses), opiates or oral steroids during the 15 days prior to treatment in the study.
* Severe heart disease
* Patients unable to comply with scheduled visits, for work or spend long periods away from their habitual residence.
* Patients with active cancer or cancer diagnosed in the last five years.
* Analytical Diagnosis Hepatitis B, C or HIV infection.
* Pregnant or lactating.
* People who are taking a drug in clinical investigation or participated in any investigational study clinic (with an authorized or not) within 30 days prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT04231357
Study Brief:
Protocol Section:
NCT04231357