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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT05975957
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes, aged between 50 and 75 years;
* Uni or bilateral symptomatic gonarthrosis grades II or III according to the Kellgren-Lawrence classification confirmed on radiographs with weight bearing in anteroposterior, lateral and axial patella. When the disease is bilateral, the knee indicated by the patient as being the most symptomatic will be included;
* Complaint of knee pain ≥4 on the Visual Analogue Scale at the time of inclusion in the study;
* Able to walk independently, with or without walking aids;
* Cognitive ability to answer questionnaires and perform physical tests;
* Agreement to participate in the study by signing the Free and Informed Consent Form (TCLE).
Exclusion Criteria:
* Diagnosis of active malignancy except basal cell carcinoma (BCC);
* Diseases or neurological conditions that compromise the ability to perform the physical tests;
* Epilepsy;
* Skin lesions on the lower limb, close to the TFBM application site;
* Tattoos on the lower limb, close to the TFBM application site;
* Unicompartmental or total knee arthroplasty in the knee included in the study;
* History of direct trauma to the knee included in the study within the last six months;
* Active systemic inflammatory disease;
* Rheumatological diseases;
* Any previous procedure with an intra-articular approach to the knee in the last six months;
* Anticipation of adopting another form of treatment during the study period, including arthroplasty;
* Patients undergoing knee shock wave treatment in the knee included in the study;
* Absence, inability or refusal to sign the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT05975957
Study Brief:
Protocol Section:
NCT05975957