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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT05524116
Eligibility Criteria:
Inclusion Criteria:
* Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, presence of morning knee stiffness ≤ 30 minutes)
* BMI\<40
* Knee pain on most days for 3 months or more
* Average overall knee pain severity of ≥= 4 on a 11-point numeric rating scale during previous week
* Able to attend remote sessions
* Can speak and understand English at a sufficient level to understand the study procedures and informed consent.
* Available for study duration
Exclusion Criteria:
* Contraindications to exercise
* Other pain in lower back or legs that is greater than knee pain
* Received physical therapy treatment for knee OA in the past 6 months or currently receiving physical therapy
* Received any mindfulness programs such as Tai Chi, meditation, etc. in the past 6 months or currently receiving such program
* Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer
* History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors.
* Any knee surgery in the previous 6 months
* Joint replacement in either hip or ankle
* Previous knee osteotomy partial or total knee replacement in either knee
* Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period
* Planned major surgery in the next 6 months
* Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months
* Neurological conditions that impacts motor functioning (e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc).
* Pregnancy (self-report)
* Participation in another clinical trial for any joint or muscle pain
* Suspected or known drugs or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05524116
Study Brief:
Protocol Section:
NCT05524116