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 | A person’s ability to carry out daily physical activities, ranging from self-care (e.g., bathing, combing hair) to more complex activities that require a combination of skills (e.g., driving a car). |
Patient global — shoulder | Patient-reported global rating of the status of the shoulder. |
Adverse events including death | Any major or minor adverse event that occurs during the course of the trial, including any deaths. |
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 hyperarousal symptoms. |
Participation (recreation and work) | A person’s ability to engage in a life situation, 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. |
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. |
Pathophysiological manifestations | Could be range of motion, muscle strength, radiographic outcomes, stability, fracture, malunion, weakness. |