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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT05267093
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed as hand OA according to the American College of Rheumatology (ACR) clinical classification criteria
* History of hand OA for at least 3 months before enrollment and history of taking nonsteroidal anti-inflammatory drugs (NSAIDs) to treat hand OA
* Aged 18-80 years
* At least 40 mm in visual analog scale (VAS) on the average pain intensity of the dominant hand over the last 48 hours (patients applying NSAIDs at the screening have to have an increase in pain in the dominant hand of ≥ 20 mm after 1-week washout)
* Posterior-anterior radiographs of the dominant hand shows Kellgren-Lawrence grade 1, 2, or 3 changes in symptomatic joints
* Negative results in both rheumatoid factor and anticyclonic citrullinated peptide
* Able to comply with the study protocol and understand the medical information forms
* Voluntarily sign the informed consent
Exclusion Criteria:
* History or current evidence of secondary OA (due to causes other than a solely degenerative joint disease) or symptomatic OA at additional locations besides the hand(s) requiring treatment, or any painful syndrome of the upper limb which may interfere with evaluation of hand pain;
* History of inflammatory arthritis (such as rheumatoid arthritis (RA) or psoriatic arthritis), hemochromatosis, metabolic, or neuropathic arthropathies;
* History of trauma, dislocation or operation to the hand or arm in the previous 3 months;
* Hand pain and stiffness due to tissue scarring or tendinitis;
* Skin damage or serious skin disorders in the hands;
* Intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 days prior to beginning the study;
* Oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronic acid injection within 3 months preceding enrollment;
* Serious uncontrolled medical conditions such as cancer, uncontrolled cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder;
* Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05267093
Study Brief:
Protocol Section:
NCT05267093