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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT03008668
Eligibility Criteria:
Inclusion Criteria:
* Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
* The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
* refractory knee pain for most days in the last month;
* joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
* laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count \< 2000/mm3;
* age 40 years or older;
* morning stiffness continues less than 30 minutes;
* bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).
Exclusion Criteria:
Patients will be excluded if they:
* Can not adhere to the study protocol in the future 6 months;
* Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
* Have sprain or other trauma;
* Are unable to walk properly due to foot deformity or pain;
* Are present with mental disorders;
* Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
* Females who are pregnant or lactating;
* Were using physiotherapy treatments for osteoarthritis knee pain;
* Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
* Received knee-replacement surgery;
* Were participating or had participated in the other clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03008668
Study Brief:
Protocol Section:
NCT03008668