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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT05398666
Eligibility Criteria:
Inclusion Criteria:
-Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3 of the following: age \>50 years, stiffness less than 30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth
* Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
* All concurrent medications taken for any reason stable for 14 days
* Ability to follow protocol with reference to cognitive and situational factors (e.g. stable housing, ability to attend visits)
* Ability to read and write English
* Willing and able to give informed consent
Exclusion Criteria:
* Currently enrolled in other clinical trial involving a pharmaceutical treatment
* Arthroscopic surgery scheduled within 8 months of study initiation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05398666
Study Brief:
Protocol Section:
NCT05398666