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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02984228
Eligibility Criteria:
Inclusion Criteria:
* English speaking/literate
* Age 18-100 years
* Visual analog score pain \>= 5
* Greater than or equal to 3 months of pain after onset of symptoms that has failed conservative treatments
* Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and within the past year)
* Transient relief of symptoms after diagnostic intra-articular injection into the glenohumeral joint
Exclusion Criteria:
* Non-English speaking/illiterate
* Painful active, concurrent cervical spine conditions
* Current non-steroidal anti-inflammatory drug (NSAID) use
* History of taking coumadin or similar anticoagulant, have a known coagulopathy, bleeding dyscrasia, or platelet count \< 150,000/cubic mm
* Allergic reaction to poultry or previous viscosupplementation
* Involved in workers' compensation or active litigation involving affected shoulder
* Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection
* History of corticosteroid injection to affected shoulder within the last 3 months
* History of viscosupplementation or platelet-rich plasma to affected shoulder within the last 6 months
* Presence of acute fracture
* History of shoulder tumor
* Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency virus, vasculitis, autoimmune/inflammatory disease)
* Psychiatric and somatoform disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02984228
Study Brief:
Protocol Section:
NCT02984228