Definitions of a proposed preliminary core domain set for trials of people with shoulder disorders.
| Domain | Definition |
|---|---|
| Inner core | |
| Pain | How much a person’s shoulder hurts, reflecting the overall magnitude of the pain experience (i.e., at rest, during and after activity, at night) |
| Physical function/activity | A person’s ability to carry out daily physical activities required to meet basic needs, ranging from self-care (e.g., bathing, combing hair) to more complex activities that require a combination of skills (e.g., driving a car) |
| Global perceived effect | A person’s assessment of their recovery or degree of improvement |
| Adverse events | Any major or minor adverse event that occurs during the course of the trial, including any deaths |
| Middle core | |
| Participation (recreation/work) | A person’s ability to engage in any form of play, recreational, or leisure activity acts (e.g., sports of any kind or levels), and the ability to meet physical and/or psychological demands of work (for people who work) |
| Sleep | Sleep functions such as onset, maintenance, quality, amount of sleep, and functions involving the sleep cycle. This domain also includes the effect on perceptions of alertness and sleepiness during usual waking hours |
| Emotional well-being | Effect on a person’s emotions, including levels of depression, anxiety, or other types of psychological distress. Depression refers to negative mood, loss of self-confidence, loss of motivation, and enjoyment. Anxiety refers to fear, extreme worrying, and hyper-arousal symptoms |