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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05861960
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 yrs
* Scheduled to undergo primary total shoulder arthroplasty (TSA) or reversed shoulder arthroplasty (RSA) for primary shoulder osteoarthritis or cuff tear arthropathy
* American Society of Anesthesiologists score 1, 2 or 3
* Able to provide written informed consent
Exclusion Criteria:
* Regular use of anti-depressants or anti-epileptics for any purpose, including SNRIs and gabapentinoids
* The presence of any chronic pain disorder other than osteoarthritis
* Osteoarthritis in joints other than the affected shoulder, for which arthroplasty is/will be planned in the near future
* Difficulty with or inability to perform psychophysical testing (eg. in case of cognitive or psychiatric disorders)
* Difficulty with or inability to communicate with the investigators (eg. difficulty with the Dutch language, cognitive/memory disorders)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05861960
Study Brief:
Protocol Section:
NCT05861960