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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT00609557
Eligibility Criteria:
Inclusion Criteria:
* Age 50-80
* Physician diagnosis of OA in hip, knee or spine.
* Significant activity limitation due to pain for at least one month on the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) and average pain \>5/10 on Brief Pain Inventory despite adequate treatment with acetaminophen or NSAIDs. \[This will identify an OA group with significant psychological distress and a desire for treatment.\]
* Depression status is not restricted, but will be monitored with PRIME-MD interview and the SCL-20. We anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.
Exclusion Criteria:
* Cannot read and write English
* Significant cognitive impairment
* History of psychosis or mania
* Current suicidal ideation
* Current substance abuse or dependence
* Current use of opioids or any antidepressant medication
* Use of investigational drug within the past month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT00609557
Study Brief:
Protocol Section:
NCT00609557