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:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT04034394
Eligibility Criteria:
Inclusion Criteria:
1. ethnic Chinese;
2. aged 60 years or above;
3. ability to comprehend Chinese;
4. fulfilling any 3 of the following criteria: i. morning stiffness \</= 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity for OA knee diagnosis (Altman et al., 1986);
5. having knee pain for at least 3 months;
6. Knee pain ≥4 on a Likert pain scale from 1-10; and
7. willing to provide informed consent.
Exclusion Criteria:
1. medical diagnoses or conditions that preclude individuals from active participation (e.g. dementia, post-stroke syndrome, alcohol or drug abuse);
2. knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, rheumatism) as screened according to the red flags for further investigation or referral in the National Clinical Guideline Centre 2014 Guidelines for Osteoarthritis of the knee (National Clinical Guideline Centre, 2014);
3. presence of skin lesions or infections at the treatment sites;
4. ever had knee replacement surgery or knee joint implant; and
5. ever received moxibustion, electromoxibustion or steroid injection for knee pain over the past 6 months; Further investigation or referral, either at the screening or during the study, will be made when necessary.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04034394
Study Brief:
Protocol Section:
NCT04034394